Explorez tous les épisodes du podcast Diagnosing Dx
| Titre | Date | Durée | |
|---|---|---|---|
| Could More Frequent Blood Testing Transform How We Detect Disease? | 09 Sep 2026 | 00:39:43 | |
In this episode of Diagnosing Dx, David Filby is joined by Octavian Florescu, CEO of In Diagnostics. An electrical engineer and microchip designer by training, Octavian has spent his career exploring how semiconductor technology can be applied to blood testing. After building and exiting his first diagnostics company, he took those lessons into In Diagnostics alongside his co-founder and wife, Ana. Octavian explains how the company is developing microchip-based blood testing from a drop of blood, why they are launching first in the veterinary market, and how a two-person “minimum viable company” is working towards profitability before expanding further into human diagnostics. We also discuss what founders learn when capital is scarce, why diagnostics may need different funding models, and how better access to longitudinal blood data could support more personalised healthcare. Key takeaways: Chapters: Guest: Octavian Florescu Host: David Filby 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Why Are Vector-Borne Infections Still So Difficult to Diagnose? | 02 Sep 2026 | 00:36:15 | |
In this episode of Diagnosing Dx, David Filby is joined by Nicole Bell, CEO of Galaxy Diagnostics. Nicole’s route into vector-borne disease diagnostics is deeply personal. After her husband was initially diagnosed with early-onset Alzheimer’s disease, she continued searching for answers and later discovered he had Lyme disease alongside Babesia and Bartonella infections. That experience led Nicole to Galaxy Diagnostics, where the company is working to improve direct detection of vector-borne infections using approaches including urine antigen testing and high-sensitivity PCR. Nicole discusses why these infections are so difficult to diagnose, how outdated and antibody-based testing can leave patients without clear answers, and Galaxy’s plans to take its Lyme urine antigen test through clinical studies towards FDA submission. Key takeaways: Chapters: Guest: Nicole Bell Learn more about Galaxy Diagnostics: https://www.galaxydx.com/ Host: David Filby 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| What Can Diagnostics Founders Learn From Two Successful Exits? Andrew Miller | 26 Aug 2026 | 00:36:17 | |
In this episode of Diagnosing Dx, David Filby is joined by Andrew Miller, a diagnostics founder, advisor and two-time exited CEO. A scientist by training, Andrew founded and led companies focused on rapid molecular diagnostics, taking Ionian Technologies through acquisition by Alere and later building NAT Diagnostics, which was acquired by Becton Dickinson in 2020. The technology developed at Ionian ultimately became central to Abbott’s ID NOW platform. Andrew shares what he learned from going through the acquisition process twice, why his second company was designed for sale from the outset, and the four risks he believes every diagnostics founder needs to manage: technology, operations, finance and commercial relevance. Key takeaways: Chapters: Guest: Andrew Miller, PhD Host: David Filby 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| 98% of Cancer Patients Outside the US Miss Genomic Testing. Can AI Change That? | 18 Aug 2026 | 00:38:54 | |
In this episode of Diagnosing Dx, David Filby is joined by Travis Wold, Chief Executive Officer at Imagenomix. Travis brings experience across cancer diagnostics, genomics, liquid biopsy, and international commercialization. We explore how Imagenomix is using AI to help make genomic testing more accessible to cancer patients globally. With around 98% of cancer patients outside the US not receiving NGS testing, Travis explains how analysing standard H&E pathology images could help identify patients who are more likely to benefit from confirmatory genomic testing. We also discuss Imagenomix’s commercial strategy, digital pathology partnerships, and the longer-term potential for AI to support more precise treatment decisions in oncology. Key takeaways: Chapters: Guest: Travis Wold LinkedIn: https://www.linkedin.com/in/travisjwold/ Host: David Filby 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Could 20-Minute Hormone Testing Transform Patient Care? Nedal Safwat, SVP at Canatu | 11 Aug 2026 | 00:45:30 | |
In this episode of Diagnosing Dx, David Filby is joined by Nedal Safwat, Senior Vice President of Medical Diagnostics at Canatu and President of Canatu Inc. With more than 20 years in diagnostics, Nedal has held leadership roles across Cepheid, QIAGEN, bioMérieux and Luminex. He now leads Canatu’s expansion into medical diagnostics, taking the company’s carbon nanotube technology into point-of-care testing. Nedal explains why Canatu has chosen hormone testing and sepsis as its first areas of focus, and why the company started with the unmet clinical need rather than trying to find an application for its technology. We also discuss the opportunity for faster hormone testing, the shift towards decentralised diagnostics, reimbursement and design-to-cost, and how Canatu is combining the speed of a startup with the infrastructure and backing of an established company. Key takeaways: Chapters: Guest: Nedal Safwat LinkedIn: https://www.linkedin.com/in/nedal-safwat/ Learn more about Canatu, Medical Diagnostics here: https://canatu.com/products/medical-diagnostics/ Host: David Filby 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Could a $127M Seed Round Change Women's Health Forever? - Dean Remy, Co-Founder @ Mativa Dx | 04 Aug 2026 | 00:38:25 | |
In this episode of Diagnosing Dx, David Filby is joined by Dean Remy, Co-Founder and Chief Commercial Officer at Mativa Diagnostics. Dean brings 35 years of experience across diagnostics, biotechnology, and therapeutics. He explains why pregnancy testing has barely changed in 50 years and how the traditional positive-or-negative result can leave women without critical information during the earliest weeks of pregnancy. Mativa is developing a reusable handheld device combining multiplex biomarker testing, graphene nanosensor technology, an AI-enabled app, and immediate care navigation. The company is also building a large longitudinal maternal biorepository to support future diagnostics, biomarker discovery, and therapeutic development. This is a practical conversation about maternal health innovation, consumer access, partnerships, regulation, data, and building a platform designed to support women throughout the pregnancy journey. Key takeaways: Chapters: Guest: Dean Remy Host: David Filby 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Red Drop’s Bet on Pain-Free Blood Collection and the Next Wave of Diagnostics | 28 Jul 2026 | 00:38:10 | |
In this episode of Diagnosing Dx, David Filby is joined by Thomas Briggs, Chief Growth Officer at RedDrop Dx. We also get into the commercial reality behind a product like this: where the most promising markets are, why education still matters, how labs and platforms need to adapt, and what it takes to build a medtech business without following the usual VC-heavy playbook. This is a practical conversation about workflow, access, patient experience, and what happens when a simple shift in blood collection could unlock broader changes across diagnostics and healthcare delivery. | |||
| Why Cancer Patients Still Die From Infections We Can't Diagnose - Karius | 21 Jul 2026 | 00:51:23 | |
In this episode of Diagnosing Dx, David Filby is joined by Alec Ford, Chief Executive Officer at Karius. Alec brings decades of leadership experience across therapeutics, vaccines, and genomics. In this conversation, we explore how Karius is bringing genomics into infectious disease and why the company has focused so sharply on immunocompromised patients. The scale of the unmet need is staggering. Alec explains that 52% of cancer deaths in the US are due to infection rather than the underlying malignancy, rising to more than 60% in hematologic malignancies. He also shares that there are around 4 million hospital admissions for infection among cancer patients in the US each year, yet the standard hospital workup can still fail to identify the cause in far too many cases. We also discuss the company’s growth, physician adoption, and why outpatient infectious disease testing could become a major next step. This is a practical conversation about infectious disease diagnostics, commercialization, and building in one of the most important unmet areas in healthcare. Key takeaways: 🔹 Why infectious disease remains one of the biggest threats to immunocompromised patients Chapters: Guest: Alec Ford Host: David Filby Learn more about Karius here: https://kariusdx.com/ 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Can AI Rescue Cancer Drugs That Clinical Trials Say Have Failed? | 15 Jul 2026 | 00:36:28 | |
In this episode of Diagnosing Dx, David Filby is joined by Alexander Bagaev, Chief Product Officer at BostonGene. Alexander has spent more than a decade helping build BostonGene from an early-stage team into a global precision medicine company. In this conversation, we explore why oncology is moving beyond single biomarkers and how BostonGene has expanded from diagnostics into AI-powered treatment selection and clinical trial support. We also discuss the challenge of bringing more comprehensive diagnostics into routine use, the role of multimodal data in better decision-making, and how BostonGene is working with pharma to design smarter trials from the outset. This is a practical conversation about precision oncology, multimodal diagnostics, AI in drug development, and turning complex biology into clinically useful decisions. Key takeaways: 🔹 Why single-gene and narrow-panel testing often misses the full picture in oncology Chapters: Guest: Alexander Bagaev LinkedIn: https://www.linkedin.com/in/alexander-bagaev-5548166b/ Host: David Filby 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| What If We Could Test Depression Drugs Before Patients Take Them? Dr Talia Cohen Solal - NeuroKaire | 07 Jul 2026 | 00:29:19 | |
In this episode of Diagnosing Dx, David Filby is joined by Talia Cohen Solal, CEO at NeuroKaire. Talia is a neuroscientist by training who spent more than a decade in academia, including time at Oxford, UCL, and Columbia, before moving into the startup world to get closer to real patient impact. In this conversation, we explore why precision medicine has transformed fields like oncology but still has so far to go in psychiatry, and how NeuroKaire is trying to change that. We discuss the limits of current antidepressant prescribing and how NeuroKaire is using patient-derived neurons to predict which treatments are most likely to work for each individual. This is a practical conversation about precision psychiatry, commercialization, clinical evidence, and what it takes to bring better mental health diagnostics into real patient care. Key takeaways: 🔹 Why psychiatry still lacks the precision medicine approach seen in other fields Guest: Talia Cohen Solal LinkedIn: https://www.linkedin.com/in/talia-cohen-solal-5b49a78/ Host: David Filby Chapters: 00:00 Introduction to Talia Cohen Solal and her background 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Why AI Multiomics Will Replace Ultrasound in Liver Cancer Screening with Bharat Tewarie | 30 Jun 2026 | 00:31:11 | |
In this episode of Diagnosing Dx, David Filby is joined by Bharat Tewarie, MD, MBA, CEO at Helio Genomics.
Bharat has led Helio Genomics since July 2025, bringing decades of global healthcare leadership across pharma, biotech, diagnostics, and digital health. In this conversation, we explore why liver cancer surveillance still relies too heavily on outdated imaging, why so many high-risk patients fall through the cracks, and how Helio Genomics is trying to change that with HelioLiver, its blood-based test designed to improve early detection.
We discuss the limitations of ultrasound in liver cancer screening, the promise of AI-powered multiomics, and why early detection only matters if patients can actually access it. Bharat also shares how his clinical and commercial background shapes Helio’s strategy, from workflow design and physician adoption to partnerships, awareness, and the infrastructure needed to move from scientific validation to real clinical impact.
This is a practical conversation about liver cancer, access, commercialization, and what it takes to turn better diagnostics into better outcomes.
Key takeaways:
🔹 Why liver cancer surveillance still leaves too many high-risk patients undetected 🔹 How AI-powered multiomics and HelioLiver could improve early liver cancer detection 🔹 Why access and workflow matter just as much as scientific performance 🔹 How partnerships can accelerate commercialization and patient reach 🔹 What Helio Genomics is building beyond HelioLiver as it expands its platform
Guest: Bharat Tewarie, MD, MBA CEO at Helio Genomics LinkedIn: https://www.linkedin.com/in/bharattewarie/
Host: David Filby Founder and CEO of Elevra Consulting LinkedIn: https://www.linkedin.com/in/davidfilby/ Chapters:
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Start with Reimbursement and Work Backwards - Jonathan Romanowsky | 17 Jun 2026 | 00:46:00 | |
In this episode of Diagnosing Dx, I’m joined by Jonathan Romanowsky, co-founder of Inflammatix and Principal at Kadima Spark.Jonathan shares lessons from leading diagnostics launches at CareDx, CardioDX, Veracyte, and Inflammatix. We discuss commercialization, reimbursement, fundraising, and why startups need to think about market adoption much earlier than before.We also explore Inflammatix’s evolution into a full IVD company and the key factors that separate diagnostics companies that launch from those that successfully scale.Key takeaways:🔹 Why reimbursement strategy needs to shape diagnostics planning from the start🔹 What makes a launch succeed beyond strong science and clinical validation🔹 Why early-stage companies now need commercial credibility much sooner🔹 How Inflammatix evolved from a molecular signature company into an IVD platform business🔹 What diagnostics founders need to understand about scale, systems, and adoption in 2026Chapters:01:28 Jonathan Romanowsky’s background and career in diagnostics06:20 Why he launched Kadima Spark and what companies need most today11:46 How fundraising pressure is changing commercial strategy22:00 The origin story of Inflammatix29:16 Building a platform company and preparing for launch33:23 Why some diagnostics launches succeed and others fail41:44 How early adoption really works inside health systems44:32 Jonathan’s outlook on the diagnostics market in 2026Guest: Jonathan RomanowskyMedical technology commercialization expert, co-founder of Inflammatix, and Principal at Kadima SparkLinkedIn: https://www.linkedin.com/in/jonathan-romanowsky-6a122/Host: David FilbyFounder and CEO of Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.#Diagnostics #Commercialization #Inflammatix #MedicalTechnology #IVD #Biotech #HealthTech #Reimbursement #ProductMarketFit #Fundraising #GoToMarket #ClinicalAdoption #Veracyte #CareDx #DiagnosingDx | |||
| The EU Market Access Playbook for Diagnostics Companies - Svetlana Nikic | 28 May 2026 | 00:46:01 | |
In this episode of Diagnosing Dx, I’m joined by Svetlana Nikic, Founder of Precision Oncology Consulting.Svetlana shares her journey from Roche and Illumina into building her own consultancy focused on helping diagnostics companies navigate the realities of market access in Europe. We explore the gap between innovation and implementation, why strong science alone does not guarantee patient access, and what US diagnostics companies often underestimate when they look at Europe as a commercial opportunity.We also discuss what it really takes to make oncology diagnostics work across European markets, from KOL engagement and clinical utility studies to health economics, reimbursement strategy, and the complexity of regional healthcare systems. This is a practical conversation about precision oncology, policy, and why implementation may now matter more than innovation.Key takeaways:🔹 Why innovation without implementation does not create real patient impact🔹 What diagnostics companies need to understand before entering Europe🔹 Why clinical utility alone is often not enough for reimbursement in European markets🔹 How KOL engagement, local evidence, and health economics shape adoption🔹 Why diagnostics now needs more implementation focus and less innovation for innovation’s sakeGuest:Svetlana NikicLinkedIn: https://www.linkedin.com/in/svetlananikic/Host:David FilbyLinkedIn: https://www.linkedin.com/in/davidfilby/Chapters:01:50 Svetlana Nikic’s background in diagnostics and oncology07:37 What Precision Oncology Consulting helps companies do in Europe10:25 When diagnostics companies should start planning for Europe15:23 How reimbursement works across European markets19:22 Why KOL engagement is so important for market access20:57 Choosing the right European market and identifying low-hanging fruit25:28 Why the reimbursement bar is often higher in Europe43:30 Diagnostics in 2026: implementation, policy, and what needs to change next🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.#PrecisionOncology #Diagnostics #MarketAccess #Reimbursement #Europe #Oncology #BiomarkerTesting #healthcarepolicy #ClinicalUtility #HealthEconomics #CancerDiagnostics #LifeSciences #HealthCare #PrecisionMedicine #Innovation | |||
| The Future of Kidney Transplant Monitoring: Moving Beyond Biopsies - Sara Barrington, CEO of Verici Dx | 19 May 2026 | 00:45:07 | |
In this episode of Diagnosing Dx, I’m joined by Sara Barrington, CEO at Verici Dx. Sara explains how Verici Dx is tackling one of the biggest unresolved problems in kidney transplant care: helping clinicians monitor patients more precisely after transplant without relying so heavily on biopsies and legacy testing. We explore why balancing rejection risk against unnecessary immunosuppression is so difficult, and how better molecular insight could support earlier, more accurate decisions. We also discuss Verici Dx’s RNA sequencing and AI-driven approach, the decision to license one test to Thermo Fisher while commercialising another directly, and what it means to build a diagnostics company that went public from day one. This is a practical conversation about transplant medicine, commercialization, and better clinical decision-making. Key takeaways: 🔹 Why post-transplant monitoring still relies too heavily on invasive and outdated methods 🔹 How RNA sequencing and AI could improve rejection prediction and patient management 🔹 Why reducing unnecessary immunosuppression is such an important clinical goal 🔹 How Verici Dx built an end-to-end transplant testing strategy across pre- and post-transplant care 🔹 What licensing, reimbursement, and public-market strategy look like in a real diagnostics company Guest: Sara Barrington CEO at Verici Dx LinkedIn: https://www.linkedin.com/in/sara-barrington-06926382/ Host: David Filby LinkedIn: https://www.linkedin.com/in/davidfilby/ 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| How Cleveland Diagnostics Is Redefining Prostate Cancer Testing | 07 May 2026 | 00:44:30 | |
In this episode of Diagnosing Dx, I’m joined by Arnon Chait, PhD, MBA, Chief Innovation Officer at Cleveland Diagnostics.Arnon shares his journey from NASA physicist to diagnostics innovator, and explains how Cleveland Diagnostics tackled one of the biggest challenges in prostate cancer testing: turning a widely used but flawed marker like PSA into something more clinically useful. We explore the role of protein structure and biomarkers in disease, why so many diagnostics fall short after the science is proven, and what it means to build from real clinical need rather than lab-first thinking.We also discuss the road from development to commercialization, the realities of regulatory strategy and FDA approval, and where diagnostics could be heading next as AI and new technologies reshape disease detection. This is a practical conversation about what it really takes to make diagnostics work in the real world.Key takeaways:🔹 Why strong science alone is not enough to build a successful diagnostic🔹 How Cleveland Diagnostics rethought prostate cancer testing beyond traditional PSA🔹 Why clinical utility, adoption, and reimbursement matter as much as validation🔹 What Arnon learned moving from physics and space science into diagnostics🔹 How AI and new technologies could shape the future of disease detectionGuest:Arnon Chait, PhD, MBAChief Innovation Officer, Cleveland DiagnosticsLinkedIn: https://www.linkedin.com/in/arnonchait/ Host:David FilbyFounder & CEO, Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/Chapters:00:00 Introduction and background03:56 Transition from NASA to diagnostics06:48 Lessons from NASA applied to diagnostics09:40 Founding Cleveland Diagnostics and developing the prostate cancer test15:52 Clinical challenges in prostate cancer18:31 Commercialization and FDA approval21:53 Future of Cleveland Diagnostics and the impact of AI27:22 Market outlook, industry changes, and lessons learned🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.#Diagnostics #ProstateCancer #Biotech #Biomarkers #Proteomics #PrecisionMedicine #MedicalDiagnostics #HealthcareInnovation #DiseaseDetection #MolecularDiagnostics #ClinicalUtility #AIinHealthcare #CancerDiagnostics #LifeSciences #DiagnosingDx | |||
| From Single Cell to Atera: The Future of Biology Measured at Scale - Serge Saxonov, Co-founder & CEO of 10x Genomics | 29 Apr 2026 | 00:47:01 | |
In this episode of Diagnosing Dx, I’m joined by Serge Saxonov, Co-founder and CEO of 10x Genomics, a leader in single cell and spatial biology. Serge shares the story behind 10x Genomics, the evolution of its foundational technologies, and the launch of Atera, a new platform designed to enable whole transcriptome analysis in tissue at scale with single cell level sensitivity. We explore why biology has been fundamentally limited by the way we measure it, what changes when those constraints are removed, and how better tools can open up entirely new possibilities for discovery and precision medicine. We also discuss the intersection of AI and biology, the challenge of translating research tools into clinical impact, and what it takes to build and scale a category-defining company in life sciences. From innovation and platform thinking to talent, culture, and the future of biotech, this is a practical conversation about how the next generation of biology tools could shape healthcare. Key takeaways: 🔹 How 10x Genomics helped define the single cell and spatial biology category 🔹 Why better measurement tools can fundamentally change what is possible in biology 🔹 How AI and biology together could accelerate discovery and precision medicine 🔹 Why most research technologies never make it into the clinic 🔹 What skills, culture, and execution will matter most in biotech over the next decade Guest: Serge Saxonov Co-founder and CEO, 10x Genomics LinkedIn: https://www.linkedin.com/in/serge-saxonov-7b42572/ Host: David Filby Founder and CEO of Elevra Consulting LinkedIn: www.linkedin.com/in/davidfilby/ Key chapters: 00:00 Introduction and background of Serge Saxonov 14:32 The birth of 10x Genomics 25:54 The future of disease understanding and diagnostics 28:09 Evolution of 10x Genomics and market fit 34:25 Building culture, talent, and innovation at scale 38:27 Skills for the future in the age of AI 40:47 The convergence of AI and biology for precision medicine 46:51 Future directions for 10x Genomics and new technologies 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| True At-Home Diagnostics: Reshaping Infectious Disease with Nathalya Mamane, CEO of Anywhere Dx | 27 Apr 2026 | 00:41:08 | |
In this episode of Diagnosing Dx, I’m joined by Nathalya Mamane, Co-Founder and CEO at Anywhere Dx. Nathalya shares the origin story behind Anywhere Dx and how a personal pain point led her to build a diagnostics company focused on bringing molecular testing into the home. We explore why the current standard of care for infectious disease testing is still too slow, too expensive, and too dependent on centralised infrastructure, and what COVID revealed about how people actually want to engage with diagnostics when access and convenience matter most. We also discuss what it really takes to build an at-home diagnostic that can scale, from creating a fully disposable, instrument-free molecular platform to navigating regulatory validation, strategic partnerships, and the commercial realities of diagnostics today. This is a practical conversation about access, simplicity, and what it means to design diagnostics for real consumer use rather than idealised clinical workflows. Key takeaways: 🔹 Why most at-home diagnostics still fall short on simplicity and scalability 🔹 How Anywhere Dx is approaching low-cost, disposable molecular testing 🔹 Why strategic partnerships are critical for commercialising diagnostics effectively 🔹 What COVID revealed about consumer behaviour and diagnostic access 🔹 Why funding, validation, and regulatory strategy remain major hurdles in diagnostics Guest: Nathalya Mamane LinkedIn: www.linkedin.com/in/nathalya-mamane/ Learn more about Anywhere Dx: https://www.anywhere.health/ Host: David Filby LinkedIn: www.linkedin.com/in/davidfilby/ Learn more about Elevra Consulting: https://elevraconsulting.com/ Key chapters: 01:48 Nathalya’s journey into diagnostics 03:38 The birth of Anywhere Dx 07:54 Technology and product overview 10:45 Market need, strep, and the impact on healthcare systems 14:44 Science behind the product 19:41 Development status and funding challenges 26:19 Commercial strategy, partnerships, and regulatory pathway 30:18 Investor sentiment and market outlook 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| The New Rules of Diagnostics: Lean Teams, Faster Revenue, Smarter Growth - MJ Hymes, i5 BioPartners | 22 Apr 2026 | 00:40:53 | |
In this episode of Diagnosing Dx, I’m joined by MJ Hymes, Managing Partner at i5 BioPartners. MJ shares his journey from molecular biology into the commercial side of life sciences, and explains why great science alone is rarely enough to build a successful diagnostics or biotech company. We explore the gap between innovation and execution, why so many early-stage companies struggle to turn promising technology into real traction, and how the funding landscape has shifted for founders building today. We also discuss what it takes to get a life sciences company market-ready, from building leaner models earlier on to navigating commercialization, fundraising, and strategic support at the right time. From AI and multiomics to emerging technologies in diagnostics and drug discovery, this is a practical conversation about turning early-stage science into a real business. Key takeaways: 🔹 Why strong science alone is not enough to build a successful company 🔹 How early-stage biotech and diagnostics teams should think about commercialization sooner 🔹 Why product-market fit matters earlier than many founders realise 🔹 How the funding environment is changing for pre-seed to Series A companies 🔹 What makes a pitch deck, investor process, and go-to-market strategy more effective Chapters: 00:00 Introduction and background of MJ Hymes 03:26 Transitioning from science to commercialization 06:16 The formation of i5 Bio Partners 09:41 Market trends and outsourcing in life sciences 12:20 Supporting early-stage companies and revenue generation 18:15 Exciting developments in life sciences 21:21 Common gaps in early-stage companies 24:36 Fundraising strategies, pitch decks, and market insights 30:39 Establishing product-market fit 33:33 Future plans for i5 Bio Partners Guest: MJ Hymes LinkedIn: https://www.linkedin.com/in/matthewhymes Host: David Filby LinkedIn: https://www.linkedin.com/in/davidfilby/ Resources mentioned: BioTools Innovator Program - https://biotoolsinnovator.com/ 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| “Wait and Watch” Is Failing Cancer Patients — Harbinger Health on What Comes Next | 15 Apr 2026 | 00:48:50 | |
In this episode of Diagnosing Dx, I’m joined by Ajit Singh, CEO at Harbinger Health.Ajit has spent decades building, scaling, and investing in diagnostics companies, and this conversation draws on that full perspective. We explore why cancer diagnosis remains one of the biggest unresolved problems in care, what happens after suspicion enters the system, and why so many patients still face delays, uncertainty, and fragmented pathways before they get answers.Ajit explains how Harbinger Health is approaching this challenge, not by competing directly with existing screening models, but by helping define a new category focused on resolving ambiguity earlier and more effectively. We also discuss what it takes to build in diagnostics today: operational agility, leadership transitions, stakeholder complexity, commercialisation strategy, and the capital landscape shaping biotech in 2026.This is one of the most important conversations we’ve had on Diagnosing Dx, a practical look at what separates diagnostics companies that launch from those that actually scale.Key takeaways:🔹 Why healthcare innovation depends on nimbleness, not just process🔹 What it takes to build a new category in cancer detection🔹 Why leadership needs to evolve as a diagnostics company grows🔹 How strong positioning and ecosystem leverage can shape fundraising success🔹 Why stakeholder complexity is one of the biggest barriers to adoptionKey chapters:00:00 Introduction to diagnostics, capital, and the market landscape03:57 Ajit Singh’s career journey and lessons from Siemens10:02 Moving from corporate leadership to startup life12:57 Harbinger Health and the challenge of cancer diagnosis18:48 Building a new category in cancer detection23:52 Early testing, commercialization, and market adoption30:52 Leadership transition, company growth, and scaling33:15 Venture capital, funding, and future growth strategy37:08 Navigating complexity in healthcare and the role of mentorship43:06 Future milestones, product launches, and the capital landscapeGuest:Ajit SinghCEO, Harbinger Health LinkedIn: https://www.linkedin.com/in/ajit-singh-flagship/ Host: David FilbyCEO, Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Women Wait 11 Years for a Diagnosis, Endometrics Are Changing That - Yana Aznavour | 08 Apr 2026 | 00:36:22 | |
This week I’m joined by Yana Aznavour, MD, PhD, OB-GYN surgeon and Founder & CEO of Endometrics. We unpack one of the biggest failures in modern healthcare: why women are still waiting up to 11 years for an endometriosis diagnosis, why the current standard still relies on surgery, and what it takes to build a diagnostic that clinicians will actually trust and use. This conversation goes beyond the science. We also explore why so many diagnostics fail at the point of adoption, what founders consistently get wrong when bringing new tests to market, and why evidence, workflow fit, and clinical credibility matter just as much as innovation itself. Key takeaways: 🔹 Why endometriosis diagnosis still takes years for so many women 🔹 How a non-invasive diagnostic could change the standard of care 🔹 Why trust, evidence, and workflow fit determine whether a test gets adopted 🔹 What founders often miss when building and commercialising diagnostics Chapters: 00:00 Introduction to Yana Aznavour and Endometrics 03:45 Transition from Clinical Practice to Entrepreneurship 06:51 The Vision Behind Endometrics 09:49 Recent Achievements and Recognition 12:52 Understanding the Unmet Needs in Women's Health 15:58 Current Status and Future Plans for Endometrics 19:00 Challenges and Opportunities in the Diagnostics Market 22:00 The Importance of Clinical Impact in Innovation 25:04 Building a Strong Team and Advisory Board 27:53 Future Directions and Expanding the Platform Resources mentioned: RADx® Tech ACT ENDO Challenge (NIH) - https://www.nichd.nih.gov/research/supported/challenges/radx-tech-endometriosis Guest: Yana Aznavour, MD, PhD LinkedIn: https://www.linkedin.com/in/yana-aznavour-md/ Host: David Filby LinkedIn: https://www.linkedin.com/in/davidfilby/ Diagnosing WDx is a sister series from Diagnosing Dx, hosted by Elevra Consulting, spotlighting the gaps, opportunities, and innovations shaping the future of women’s diagnostics. Learn more about Elevra Consulting: https://elevraconsulting.com/ 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Finding Lung Cancer Before It’s Too Late: From Uncertainty to Action | 31 Mar 2026 | 00:42:53 | |
In this episode of Diagnosing Dx, I’m joined by Maria Zannes, Chief Executive Officer and Director at bioAffinity Technologies. Maria shares her journey from journalism and business leadership into diagnostics, and explains how bioAffinity Technologies is building a non-invasive platform for lung disease diagnosis, starting with early lung cancer detection. We explore the limitations of current pathways for indeterminate pulmonary nodules, how CyPath Lung is designed to support faster, more confident decision-making, and why earlier detection can have such a major impact on outcomes. We also discuss what it really takes to build and scale in diagnostics, from clinical validation and workflow adoption to balancing commercialization with continued innovation. From lung cancer screening and clinical trials to asthma, COPD, and future opportunities in the platform, this is a practical conversation about bringing meaningful diagnostic advances to market. Key takeaways: 🔹 Why early detection remains one of the biggest opportunities in lung cancer care 🔹 How non-invasive testing could improve patient comfort and clinical decision-making 🔹 Why strong science, clinical validation, and commercial execution all matter in diagnostics 🔹 How bioAffinity Technologies is balancing commercialization with continued discovery and innovation 🔹 What the company’s upcoming military and VA clinical trial could mean for wider adoption Chapters: 00:00 Introduction 02:24 Why Texas is becoming a hub for diagnostics companies 02:58 Maria Zannes’ background and the origins of bioAffinity Technologies 05:42 Personal motivation, team building, and the role of science in innovation 09:27 bioAffinity’s platform technology and how CyPath Lung works 11:31 Early lung cancer detection, screening awareness, and non-invasive testing 16:25 Commercial strategy, test performance, and real-world use cases 20:02 Team growth, company milestones, and the journey to commercialization 23:27 Clinical validation, the upcoming military and VA trial, and the economic case for CyPath Lung 31:36 Company setup, future growth, therapeutic potential, and what’s next Guest: Maria Zannes LinkedIn: https://www.linkedin.com/in/maria-zannes-32496815/ Host: David Filby LinkedIn: https://www.linkedin.com/in/davidfilby/ 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| Scaling Precision Medicine: Faster Reports, Smarter Trials, Better Care - Garreth Hippe at GenomOncology | 24 Mar 2026 | 00:42:11 | |
In this episode of Diagnosing Dx, I’m joined by Garreth Hippe, Chief Commercial Officer at GenomOncology, a software company helping turn complex genomic data into faster, more actionable decisions in oncology. Garreth has spent much of his career in clinical genomics, bioinformatics, and healthcare software, and in this conversation we explore how the field has evolved over the last 20 years, from far slower sequencing workflows to a point where whole genomes can now be analysed in clinically meaningful timeframes. We also unpack how GenomOncology is helping labs bring genomic reporting in-house, reduce turnaround times, ease pressure on molecular pathologists, and match patients to relevant clinical trials before those opportunities are missed. A big part of the discussion focuses on AI, not as hype, but as a real force multiplier in healthcare software. Garreth shares how it is accelerating development, improving reporting workflows, and opening up new ways to work with clinical and omics data. We also discuss why genomics is still underused in parts of oncology, where adoption is heading next, and why whole genome sequencing could play a much bigger role in the future of cancer care. Key takeaways: 🔹 How software is helping translate genomic complexity into clinical action 🔹 Why clinical trial matching remains such a critical challenge in oncology 🔹 Where AI could have the biggest impact across precision medicine 🔹 Why whole genome sequencing may define the future of cancer care Chapters: 00:00 Introduction 01:56 Garreth Hippe’s background in clinical genomics and software 03:04 What clinical genomics means: somatic vs germline testing 05:28 How software in genomics has evolved over the last 20 years 07:14 AI in healthcare and precision medicine 09:34 What GenomOncology does and where it fits in the oncology workflow 15:14 How AI is accelerating product development and lean growth 20:21 The core problems GenomOncology is solving in reporting and clinical trial matching 26:10 Company progress, product development, and commercial milestones 33:46 Adoption challenges in genomics and the future of whole genome sequencing 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics. | |||
| The Women’s Health Data Gap: Why Diagnostics Are Decades Behind - Marra Francis, MD | 12 Mar 2026 | 00:48:33 | |
In this first episode of Diagnosing WDx, the new women’s health-focused sister series from Diagnosing Dx, I’m joined by Marra Francis, MD, board-certified OB-GYN, women’s health expert, and advisor to multiple early-stage diagnostics companies.
Recorded in the week of International Women’s Day, this conversation explores one of the biggest blind spots in healthcare: the historic and ongoing gap in women’s diagnostics.
Marra breaks down why women were excluded from clinical trials for decades, why many diagnostics and therapeutics still used today were originally studied in men, and why conditions like preeclampsia remain dangerously under-researched. We also explore the role of startups, investors, and AI in helping close the data gap and drive a new era of innovation in women’s health.
If Diagnosing Dx shines a light on the diagnostics industry, Diagnosing WDx shines a light on the women it has overlooked for far too long.
Key takeaways:
🔹 Why women were historically excluded from clinical research 🔹 How gaps in data still affect diagnostics and therapeutics today 🔹 Why preeclampsia and autoimmune disease expose major weaknesses in women’s health research 🔹 The investment gap holding back progress in women’s diagnostics 🔹 Where AI, startups, and new research models could help move the field forward
Chapters: 00:00 Introduction 01:02 Welcome to Diagnosing WDx 01:53 Marra’s background and path into women’s health diagnostics 04:49 The real diagnostic gaps women face in clinical practice 08:05 Marra’s work across women’s health startups and innovation 11:11 Consumer health, trust, and access to testing 17:13 The history of women’s exclusion from clinical trials 20:10 Preeclampsia, autoimmune disease, and the real-world impact of the data gap 25:41 Why progress in women’s health is still not moving fast enough 29:22 Diagnostics tested in men and what that means for women today 32:59 Can AI help close the women’s health data gap? 42:10 What needs to change next in women’s diagnostics 47:47 Why Diagnosing WDx matters
Guest: Marra S. Francis LinkedIn: https://www.linkedin.com/in/marrasfrancis/
Resources mentioned: 4. Nobel Prize in Medicine and Physiology
Diagnosing WDx is a sister series from Diagnosing Dx, hosted by Elevra Consulting, spotlighting the gaps, opportunities, and innovations shaping the future of women’s diagnostics.
Learn more: https://elevraconsulting.com/
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| The $4 Billion Problem in Lyme Diagnostics with Aces Diagnostics | 17 Feb 2026 | 00:42:33 | |
In this episode of Diagnosing Dx, I’m joined by Tammy Crawford, Chief Executive Officer, and Holly Ahern, Chief Scientific Officer at Aces Diagnostics, a company building what could become the first highly accurate test across all stages of Lyme disease. We explore why early Lyme is so often missed, the myth of the bullseye rash, and the structural gaps in today’s testing pathway. Tammy and Holly explain how their personal experiences shaped Aces Diagnostics’ mission and how they’re approaching the problem with a more rigorous, data-driven framework built for real-world adoption. This conversation is a grounded look at what it takes to restore confidence in infectious disease diagnostics and why more reliable testing could transform both patient outcomes and healthcare economics. Key takeaways: 🔹 Why current Lyme diagnostics frequently miss early-stage disease 🔹 How combining multiple biomarkers improves diagnostic accuracy 🔹 The role of machine learning in interpreting complex immune signatures 🔹 Why FDA approval is essential for trust, adoption, and scale 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Reimbursement-First Thinking in Early-Stage Diagnostics with OraLiva | 11 Feb 2026 | 00:43:47 | |
In this episode of Diagnosing Dx, I’m joined by Spencer Price, Chief Executive Officer at OraLiva, a company building an AI-powered precision diagnostic designed to transform oral cancer detection and shift the standard of care. We explore Spencer’s unconventional move from autonomous vehicles into diagnostics, why OraLiva built commercialisation and reimbursement strategy into the company from day one, and what it really takes to turn breakthrough science into a product that fits seamlessly into clinical workflows. Spencer shares how understanding the healthcare landscape early can shape smarter partnerships, stronger positioning, and long-term scalability. This conversation is a grounded look at how diagnostics startups can balance innovation with practicality, building technology that not only works, but gets adopted and paid for. Key takeaways: 🔹 Why reimbursement strategy needs to start at seed stage 🔹 How AI is accelerating preventative diagnostics in oral cancer 🔹 The importance of stakeholder engagement across the healthcare ecosystem 🔹 Why flexibility and optionality are critical in early-stage diagnostics companies 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Building Diagnostics Without Building Hardware: Checktor’s Strategic Play | 05 Feb 2026 | 00:41:55 | |
In this episode of Diagnosing Dx, I’m joined by Jake Lesinski, Co-founder and CEO of Checktor Biosciences, an ETH Zurich spin-out building a CRISPR-based chemistry platform designed to upgrade existing diagnostic systems rather than replace them. We explore why speed, decentralisation, and practical integration, not hype, will define the next wave of molecular diagnostics. Jake shares how Checktor is approaching CRISPR from a clinical and commercial perspective, why matching PCR-level performance matters, and how distribution strategy can make or break even the strongest science. This conversation is a grounded look at how diagnostics companies can scale responsibly, partner intelligently, and deliver real value to patients and healthcare systems. Key takeaways: 🔹 Why rapid, accurate diagnostics remain one of healthcare’s biggest unmet needs 🔹 How CRISPR is finally finding its footing in real clinical workflows 🔹 Why upgrading existing diagnostic infrastructure beats starting from scratch 🔹 What founders need to understand about partnerships, validation, and scale 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Why Great Diagnostics Fail: Turning Single-Cell Science Into a Real Product | 28 Jan 2026 | 00:41:42 | |
In this episode of Diagnosing Dx, I’m joined by Zivjena Vucetic, Chief Medical Officer at Mission Bio, to explore what it really takes to turn breakthrough diagnostics science into tools that change clinical decisions. With nearly two decades across oncology, neurology, infectious disease, and single-cell technologies, Zivjena shares a rare perspective on the messy middle of diagnostics, where great science often stalls before reaching patients. We dive into why starting with a clinical decision (not the technology) matters, how single-cell multiomics can unlock new insight in complex diseases like AML, and why diagnostics companies must think like product builders to succeed. This conversation cuts through the hype to focus on adoption, workflow, validation, and what actually drives impact in modern diagnostics. Key takeaways 🔹 Why most diagnostics fail on product design and workflow, not science 🔹 How single-cell multiomics can reveal clinically meaningful insights in heterogeneous diseases 🔹 Why defining the clinical decision and target product profile early is critical 🔹 What it really takes to move diagnostics from discovery to standard of care 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Why Diagnostic Labs Are Breaking — and How The Proficient Lab Is Fixing It - Unika Alexander | 13 Jan 2026 | 00:40:06 | |
In this episode of Diagnosing Dx, I’m joined by Unika Alexander, Co-Founder and CEO of The Proficient Lab, to unpack what’s really happening inside today’s diagnostic labs and why many are under more pressure than ever. This conversation goes beyond hype to look at the operational reality of diagnostics — from compliance and reimbursement challenges to why modern labs need better data visibility to scale sustainably. Key takeaways 🔹 Why staffing shortages are one of the biggest operational risks facing labs today 🔹 How AI can simplify compliance, audits, and data management — without adding complexity 🔹 Why data governance and traceability are critical as labs scale across sites 🔹 What diagnostic leaders need to understand about regulation, reimbursement, and efficiency 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| AGED Dx: Grit, Purpose, and the Fight to Diagnose Liver Disease Early - Rachel Zayas, CEO | 08 Jan 2026 | 00:47:53 | |
In this episode of Diagnosing Dx, I’m joined by Rachel Zayas, CEO of AGED Diagnostics, a company tackling one of the most underdiagnosed and overlooked conditions in healthcare: liver disease.
Rachel shares what it really takes to build a diagnostics company from scratch in a high-friction clinical space, why liver disease is so difficult to detect early, and how systemic gaps in specialist access are leaving high-risk patients behind. We also explore the discipline, resilience, and hard lessons that shaped AGED Diagnostics’ mission to diagnose disease earlier—before irreversible damage occurs.
This conversation is a grounded look at early diagnostics, healthcare bottlenecks, and the realities of building in an area where the need is massive, but the infrastructure is stretched thin.
Takeaways:
🔹 Why liver disease often goes undetected until it’s too late 🔹 How non-specific symptoms and specialist shortages delay diagnosis 🔹 The lessons learned as a two-time Founding CEO in Diagnostics 🔹 What early diagnostics could change for high-risk patients
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Head & Neck Cancer Is Still Found Too Late — And OrisDX Is Changing That | 17 Dec 2025 | 00:48:10 | |
In this episode of Diagnosing Dx, I’m joined by Harald Steltzer, CEO of OrisDX, a company tackling one of the most overlooked gaps in diagnostics: early detection of head and neck cancer. Harald shares his journey from biochemistry and genetics into startup leadership, and why dentistry may be one of the most overlooked frontlines for early cancer detection today. We explore how OrisDX is rethinking diagnostics to reduce clinical friction, improve patient outcomes, and tackle one of healthcare’s hardest problems: reimbursement and adoption. This episode is a focused deep dive into purpose-driven diagnostics, smart go-to-market strategy, and what it really takes to launch a new clinical test in today’s healthcare system. Key takeaways: 🔹 Why head and neck cancer remains under-detected—and how dentistry can change that🔹 The role of early detection, education, and digital health in improving outcomes🔹 How diagnostics founders should think about reimbursement from day one🔹 What it takes to take a novel diagnostic from concept to clinical launch 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| EXCLUSIVE: Inside VedaBio - The Breakthrough That Could Redefine Point-of-Care Diagnostics | 09 Dec 2025 | 00:53:31 | |
In this episode of Diagnosing Dx, I sit down with Frédéric D. Sweeney, President & CEO of VedaBio, the company pioneering a completely new class of molecular diagnostics — one that detects DNA and RNA without amplification while maintaining full clinical sensitivity in under 10 minutes.
We explore how this platform could transform urgent care, decentralised testing, and infectious disease workflows — and why VedaBio believes the next leap in molecular diagnostics won’t come from making PCR faster, but from removing amplification entirely.
Frédéric also opens up about the realities of transitioning from feasibility to product development, building the right team, navigating today’s funding climate, and why 2026 is shaping up to be a pivotal year for the company.
Takeaways:
🔹Why removing amplification could reshape point-of-care diagnostics 🔹How patient experience drives VedaBio’s product vision 🔹The importance of strategic partnerships during early scaling 🔹What founders need to know about fundraising and team building in today’s diagnostics market
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| The 20-Year Head Start: How Amprion Is Transforming Neurodiagnostics | 02 Dec 2025 | 00:46:49 | |
In this episode, Dr. Russ Lebovitz, CEO of Amprion, explains why detecting misfolded proteins years before symptoms begin could completely reshape how we diagnose Alzheimer’s, Parkinson’s, and other neurodegenerative diseases.
He breaks down how early detection unlocks new possibilities for intervention, why alpha-synucleinis such a powerful biomarker, and what it really takes to commercialise a diagnostic platform in one of the toughest areas of biotech.
Key Takeaways: 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Inside the Single-Cell Revolution: One Biosciences’ Path to Clinical Reality | 25 Nov 2025 | 00:37:00 | |
In this episode of DiagnosingDx, I’m joined by Wissam Hamou, Chief Operating Officer of One Biosciences, a company bringing single-cell diagnostics out of the lab and into real clinical practice. We explore why single-cell analysis is finally ready for the clinic, how AI is unlocking insights that were previously impossible to see, and what this technology means for trials, treatment response, and the future of precision medicine. Key Takeaways: 🔹 Single-cell technology is advancing toward real clinical validation, backed by fresh Series A funding. 🔹 AI is essential for making sense of the complex and high-dimensional data single-cell methods produce. 🔹 Cost, trust, and education remain key barriers to adoption among clinicians. 🔹 Regulatory clarity is urgently needed to establish standardized guidelines for single-cell assays. 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| The One-Hour Test That Could Stop Sepsis - Mustafa Al-Adhami from Astek Diagnostics | 19 Nov 2025 | 00:39:16 | |
In this episode of Diagnosing Dx, I’m joined by Mustafa Al-Adhami, CEO and founder of Astek Consulting.
We dive into how his team is building a rapid testing platform that can confirm a UTI, detect E. coli, and identify the right antibiotic within one hour - a breakthrough that has the potential to prevent sepsis and reshape frontline care.
We also explore the realities of building a diagnostics company today, from navigating regulatory pathways to securing funding in a challenging market.
Takeaways: 🔹Mustafa’s journey from refugee to diagnostics founder — and the mission driving Astek Consulting. 🔹How Astek’s rapid UTI platform delivers actionable, one-hour results. 🔹Why regulatory and reimbursement pathways must be built early to ensure adoption. 🔹The challenges of fundraising for diagnostics in the current environment. 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| The Rise of AI in Diagnostics & Clinical Trials - Slava Akmaev, Chief AI Officer | 10 Nov 2025 | 00:50:23 | |
In this episode of Diagnosing Dx, I’m joined by Slava Akmaev, Chief AI Officer and COO at BPGbio, and one of the earliest pioneers applying AI to diagnostics and precision medicine. We discuss how AI has evolved from early scepticism in pharma to becoming the operational backbone of modern biotech, how it’s reshaping clinical trial design and diagnostic development, and what it will take to rebuild investor confidence in the space. Takeaways: 🔹How attitudes toward AI in diagnostics and drug development have shifted over the last decade. 🔹Where AI can remove bottlenecks in clinical trials and patient selection. 🔹Why integrating AI across teams, not just data science is now essential for life sciences companies. 🔹The role of diagnostics in enabling precision medicine at scale. 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| From Type 1 Detection to Total Health: How KiHealth is Redefining Preventive Testing | 04 Nov 2025 | 00:46:27 | |
In this episode of Diagnosing Dx, I sit down with Jenna Anderson, CEO of KiHealth, the company behind a breakthrough diagnostic test that can detect Type 1 diabetes years before symptoms appear. We discuss how this innovation could transform preventative healthcare, why consumer empowerment is reshaping the industry, and how KiHealth is building a future where early detection becomes the norm. Takeaways: 🔹Why COVID-19 changed how consumers think about their health. 🔹The growing role of preventative and accessible diagnostics. 🔹How healthcare marketing can catch up with other industries. 🔹Jenna’s vision for affordable, early disease detection. 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| The Shelf Problem: Why Life-Saving Diagnostics Stay Hidden - Sally and BJ | 29 Oct 2025 | 00:46:40 | |
In this episode of Diagnosing Dx, I’m joined by Sally Bowden and BJ Kerns, founders of P3 Consulting, who help early-stage diagnostics startups navigate the realities of funding, regulation, and leadership.
We unpack why so much innovation never makes it off the shelf, what investors expect before backing a product, and how founders can de-risk their science to survive in today’s challenging market.
Takeaways: 🔹How funding constraints are reshaping diagnostics innovation. 🔹The growing importance of regulatory strategy and FDA engagement. 🔹Why strong leadership and clear product definition determine success. 🔹Signs of optimism emerging in the diagnostics market.
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Tasso’s Painless Future of Blood Testing: From Fear to Freedom | 21 Oct 2025 | 00:37:13 | |
In this episode of Diagnosing Dx, I’m joined by Ben Casavant, Co-founder and CEO of Tasso, a company redefining how blood testing works. Ben shares how a PhD side project turned into a diagnostics breakthrough, with over $120 million raised and more than two million patients served. He explains how Tasso’s painless, at-home blood collection device is making healthcare more accessible, and why innovation in something as simple as a blood draw was long overdue. Key Takeaways: 🔹Tasso’s journey from PhD research to a global diagnostics company 🔹Making blood draws painless, patient-friendly, and scalable 🔹Lessons in iteration, team culture, and deep tech innovation 🔹Why failing fast can accelerate meaningful healthcare change 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Building Better Labs: Julie Ballard on CLIA, LDTs, and the Hidden Costs of Getting It Wrong | 14 Oct 2025 | 00:55:52 | |
In this episode of Diagnosing Dx, I’m joined by Julie Ballard, founder of Carrot Clinical and Tiger Team Bio, who has helped shape leading diagnostics companies including Genomic Health, GRAIL, and Guardant Health.Julie shares her journey from clinical laboratory scientist to entrepreneur and consultant, and what she’s learned from years of helping startups navigate the complex world of lab operations and regulatory compliance. She dives into the realities of LDT validation, the high stakes of hiring, and how even well-funded teams can make costly mistakes when moving too fast.Key Takeaways:• Transitioning from clinical science to entrepreneurship in diagnostics• Why quality systems are critical for lab operations• Common mistakes in LDT development and validation timelines• The growing focus on women’s health and new opportunities for founders🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Juniper Genomics: Rewriting the IVF Playbook for Hope, Science, and Access - Kaylene Ready | 07 Oct 2025 | 00:42:39 | |
This week on Diagnosing Dx, I’m joined by Kaylene Ready, Chief Product Officer at Juniper Genomics, a company transforming the future of IVF through whole genome embryo testing. We explore how Juniper is turning IVF from a 50/50 coin flip into a more certain path to success, empowering families with better information and outcomes. Kayleen also shares how her background in genetics and startup leadership fuels her mission to make fertility treatment more accessible and effective. 🔥 What You’ll Learn: • How Juniper Genomics is improving IVF success rates through advanced genetic testing • Why education and awareness are key to genetic testing adoption • The role of genetic counselors in guiding patients and clinicians • How startups like Juniper are making IVF more accessible and efficient 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Workflow, Customers, and Course Corrections: Scott O’Brien on Scaling GenMark | 29 Sep 2025 | 00:57:50 | |
This week on Diagnosing Dx, I’m joined by Scott O’Brien, who helped lead GenMark from a small startup to a $1.8 billion acquisition by Roche.
Scott shares how his transition from science to commercial strategy shaped GenMark’s journey, the critical role of customer experience in competing against industry giants, and what it really takes to scale a diagnostics company through both breakthroughs and setbacks.
🔥 What You’ll Learn: • How commercial strategy can define success in diagnostics • The power of customer experience and retention in building long-term value • Lessons from scaling a startup to a billion-dollar acquisition • Why adaptability and feedback culture are key to growth
Whether you’re a founder, commercial leader, or diagnostics enthusiast, this conversation offers a rare inside look at the decisions that built one of the sector’s standout success stories.
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Bench in a Box: Redefining PCR for Anywhere, Anytime Diagnostics - Josh Smith | 23 Sep 2025 | 00:47:39 | |
This week on Diagnosing Dx, I’m joined by Josh Smith, founder of Bench in a Box and scientist with a background in genetics and microbiology. Josh shares the breakthrough idea that inspired his platform, the journey to patent-pending status, and the realities of building a diagnostics startup in today’s economic climate. 🔥 What You’ll Learn: • The breakthrough behind Bench in a Box and its role in simplifying diagnostics • Why fundraising is especially challenging for early-stage founders today • The value of advisory teams, feedback, and adaptability in startup success • How the diagnostics market is evolving with new technologies Whether you’re a founder, scientist, or investor, this episode offers an inside look into what it takes to innovate and scale in the diagnostics space. 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Going Global: Victoria Polyanskaya on Expanding Diagnostics Beyond the US | 17 Sep 2025 | 00:44:53 | |
This week on Diagnosing Dx, I’m joined by Victoria Polyanskaya, a healthcare leader with over 10 years of experience who is driving global expansion for LinusBio.
We explore how diagnostics companies can successfully scale internationally, the opportunities in emerging markets, and the hard truths leaders need to hear when looking abroad.
🔥 What You’ll Learn: • Why exposomics is shaping the next generation of diagnostics • How regulation in the US differs from international markets • The role of partnerships, funding, and cultural understanding in the Middle East
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics. | |||
| Mission Meets Money: Dean Remy on Fundraising and the Future of Diagnostics | 08 Sep 2025 | 00:57:49 | |
This week on Diagnosing Dx, I’m joined by Dean Remy, a 35-year veteran of the life sciences industry, founder, and fundraising strategist. Dean shares his unique journey from diagnostics into technology and commercial leadership, and why fractional leadership is becoming a smart, cost-effective model for today’s startups. We dive into the evolving world of fundraising, the growing gap between investors and early-stage companies, and why diagnostics remain one of the most vital and investable areas of healthcare. Dean also sheds light on the shifting global investment landscape, from the U.S. to Europe and the Middle East, and the most common mistakes founders make when raising capital. 🔥 What You’ll Learn: 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics. | |||
| Inside BioFire: Culture, Growth, and the Rocket Ship Ride - Rachel Jones | 03 Sep 2025 | 01:06:21 | |
This week on Diagnosing Dx, I’m joined by Rachel Jones,former Chief Commercial Officer at BioFire and now at VedaBio. Rachel shares her remarkable journey from bench scientist to helping rebrand Idaho Technology into BioFire, scaling its commercial team from just 12 people into a billion-dollar diagnostics powerhouse, and ultimately shaping one of the most iconic success stories in infectious disease diagnostics.
We dig into the culture, growth, and lessons that definedBioFire’s rise, and what it takes to balance scientific innovation with commercial execution in a fast-changing market.
🔥 What You’ll Learn: • How Rachel transitioned from the lab to commercialleadership • Why integrating science and business is key to scalingdiagnostics • The pivotal role of syndromic testing in BioFire’s success • Lessons from BioFire’s acquisition by BioMérieux and itscultural impact
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics. | |||
| From Hypothesis-Driven to Hypothesis-Free: The Future of Dx with Brad Murray | 26 Aug 2025 | 00:44:35 | |
This week on Diagnosing Dx, I’m joined by Bradley Murray, CEO and co-founder of Delve Bio. Bradley shares his journey from academic research, success as a biotech startup, investment into life sciences and onto entrepreneurship, andhow those experiences shaped his approach to building diagnostics that put patients first.
We dive into why execution, not just vision is critical for survival in today’s diagnostics market, how Delve is transforming infectious disease testing through metagenomic sequencing, and what it takes to scale a company that’s tackling some of healthcare’s toughest problems.
🔥 What You’ll Learn: • Why operational excellence is as important as scientific innovation • How metagenomic next-generation sequencing is reshaping infectious diseasediagnostics • The critical role of evidence generation for adoption and reimbursement • Why execution, not just big ideas, drives real patient impact
Whether you’re an entrepreneur, scientist, or investor in diagnostics, this episode offers a rare look into what it takes to build a company that’s changing how we fight life-threatening infections.
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics. | |||
| Truth-Seeking in Diagnostics: Lessons from Genomic Health to Mental Health - Tara Maddala | 18 Aug 2025 | 00:48:52 | |
This week on Diagnosing Dx, I’m joined by Tara Maddala,statistician, diagnostics veteran, and founder of Pandora Bio and Tiger Team Bio, whose career also spans Genomic Health and Grail.
We explore how the truth-seeking culture at Genomic Healthshaped her approach to building and advising early-stage companies, why mental health diagnostics is still decades behind, and how AI is often misrepresented in our field. Tara also shares lessons on adaptability, the pitfalls of poordata, and what it really takes to align technology, clinical design, and people for success in a fast-changing diagnostics market.
🔥 What You’ll Learn: • Why most “AI in diagnostics” is really just advancedstatistics • How early-stage founders can avoid costly mistakes withpoor data and convenience samples • The potential of behavioral and social biomarkers inmental health diagnostics • What investors are really looking for in adaptable,evidence-driven teams • How lessons from Genomic Health and Grail still shape thefuture of diagnostics today
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics. | |||
| From Science to Sales — The Hard Truths of Commercializing Diagnostics Today - Mark Oldroyd | 12 Aug 2025 | 00:55:50 | |
This week on Diagnosing Dx, I’m joined by Mark Oldroyd, a commercialisation strategist with over 30 years in healthcare, including leadership roles at Foundation Medicine, Tempus, and C2i Genomics.
Mark has guided diagnostics and omics companies across the US, Europe, and Asia, helping them find the right path from breakthrough science to a sustainable business.
🔥What You’ll Learn: • Why moving from science to market in diagnostics is harder than it looks • How funding, reimbursement, and market conditions shape your strategy • Why sometimes starting small is the smartest move • The role of AI and software in the future of diagnostics
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics. | |||
| AI, Virtual Staining & the Future of Pathology – James Kelley | 05 Aug 2025 | 00:39:55 | |
This week on Diagnosing Dx, I’m joined by James Kelley, Chief Medical Officer at Pictor Labs and a respected leader in lab medicine and diagnostics. We explore how AI is reshaping pathology, what makes virtual staining such a transformative innovation, and why data ownership and transparency are becoming urgent conversations for clinicians. From regulatory frameworks to AI education in healthcare, this episode offers a sharp look at what’s ahead. 🔥What You’ll Learn: • How virtual staining could transform pathology workflows • Why data ownership matters in AI-powered diagnostics • The current adoption curve and limitations of AI in lab medicine • What healthcare professionals need to understand about AI today 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics. | |||
| Building Assays, Battling COVID on the Frontline, and What’s Next in Dx – Vincent Funari | 28 Jul 2025 | 00:47:34 | |
This week on Diagnosing Dx, I’m joined by Vincent Funari, a genomics leader whose career spans from the Human Genome Project to pioneering liquid biopsy assays and driving innovation at NeoGenomics during its major growth years.
We dive into how Vincent scaled R&D through M&A, led testing innovation during the COVID-19 crisis, and earned praise from the FDA for breakthrough assay development. He also reflects on his path from bench scientist to CSO,and what scientists need to know about making that leap.
🔥 What You’ll Learn: • Why liquid biopsy and minimal residual disease (MRD) testing are redefining cancer diagnostics • How NeoGenomics scaled through bold acquisitions and scientific vision and navigated Covid on the front line • How FDA and Medicare recognition validated their novel assays • What it takes to move from researcher to executive in life sciences - an insight for aspiring R&D leaders
🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics. | |||