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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.

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 adoption Key chapters: 00:00 Introduction to diagnostics, capital, and the market landscape 03:57 Ajit Singh’s career journey and lessons from Siemens 10:02 Moving from corporate leadership to startup life 12:57 Harbinger Health and the challenge of cancer diagnosis 18:48 Building a new category in cancer detection 23:52 Early testing, commercialization, and market adoption 30:52 Leadership transition, company growth, and scaling 33:15 Venture capital, funding, and future growth strategy 37:08 Navigating complexity in healthcare and the role of mentorship 43:06 Future milestones, product launches, and the capital landscape Guest: Ajit Singh CEO, Harbinger Health LinkedIn: ⁠https://www.linkedin.com/in/ajit-singh-flagship/⁠ Host: David Filby CEO, Elevra Consulting LinkedIn: ⁠https://www.linkedin.com/in/davidfilby/⁠ 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

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 PMWC Conference - https://pmwcintl.com/ Health Equity Business Accelerator (Blue Cross Blue Shield of Massachusetts / MassChallenge) - https://masschallenge.org/heba-2026/ Berkeley SkyDeck Fund - https://skydeck.vc/ Granatus Ventures - https://www.granatusventures.com/ Supernode Ventures - https://www.supernode.vc/ First Spark Ventures - https://www.firstsparkventures.com/ 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.

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.

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.

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: Women’s Health Initiative - https://www.womenshealth.gov/about-us/who-we-are/our-work/womens-health-initiative MIT Catalyst Program - https://catalyst.mit.edu/ For You and Me (FYM) - https://foryouandme.org/ Nobel Prize in Medicine and Physiology - https://www.nobelprize.org/prizes/medicine/ 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.

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.

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.

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.

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.

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.

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.

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.

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.

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-synuclein is such a powerful biomarker, and what it really takes to commercialise a diagnostic platform in one of the toughest areas of biotech. Key Takeaways: 🔹Early detection is essential for slowing neurodegenerative diseases 🔹Misfolded proteins can appear up to 20 years pre-symptom 🔹Diagnostics commercialisation requires deep regulatory expertise 🔹Partnerships like Amprion’s with Mayo Clinic accelerate scaling 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics.