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
🔹 How BostonGene is combining genomics, transcriptomics, and immune profiling to improve treatment selection
🔹 Why reimbursement still lags behind the scientific need for integrated diagnostics
🔹 How multimodal AI and foundation models could reshape drug development and clinical trial design
🔹 What precision medicine companies need to understand about flexibility, regulation, and real-world adoption

Chapters:
00:00 Introduction to Alexander Bagaev
03:25 Journey from physics to immunology
05:07 The evolution of BostonGene
07:55 Precision medicine and patient-centric treatment selection
10:28 Challenges in drug development and clinical trials
13:02 Growth and milestones of BostonGene
15:19 Navigating diagnostics and the role of AI
20:48 Future opportunities and advice for early-stage companies

Guest: Alexander Bagaev
Chief Product Officer at BostonGene

LinkedIn: https://www.linkedin.com/in/alexander-bagaev-5548166b/

Host: David Filby
Founder and CEO of 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.

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
🔹 How NeuroKaire is using patient-derived neurons to guide antidepressant treatment
🔹 Why clinical trials and guideline change are essential for real adoption
🔹 How the company is balancing commercial growth with platform expansion and pharma partnerships
🔹 What the future could look like for diagnostics in depression, anxiety, ADHD, and beyond

Guest: Talia Cohen Solal
CEO at NeuroKaire

LinkedIn: https://www.linkedin.com/in/talia-cohen-solal-5b49a78/

Host: David Filby
Founder and CEO of Elevra Consulting
LinkedIn: https://www.linkedin.com/in/davidfilby/

Chapters:

00:00 Introduction to Talia Cohen Solal and her background
08:23 Transitioning from academia to startups
09:52 The vision behind NeuroKaire and precision psychiatry
12:38 Clinical trials and validation of NeuroKaire’s technology
14:37 Commercialization, distribution, and reimbursement
16:46 Education and awareness in the medical community
19:44 Future growth, market potential, and new indications
26:47 Outlook on diagnostics and the future of neurodiagnostics

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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:
00:00 Introduction to Bharat Tewarie and Helio Genomics
01:42 Bharat’s journey from medicine to business
06:25 The evolution of diagnostics, omics, and AI
10:36 Helio Genomics’ mission and differentiators
12:03 Unmet needs in liver cancer surveillance
14:01 Awareness, access, and clinical workflow challenges
19:10 The role of partnerships in commercialization
26:27 Growth strategy and the future of diagnostics

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

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.

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.

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.

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:

1. Women’s Health Initiative

2. MIT Catalyst Program

3. For You and Me (FYM)

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.

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.

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.

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.

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:
• Why diagnostics are central to the future of healthcare and early disease detection
• How fundraising strategies are changing in today’s cautious market
• The role of fractional leadership in helping startups scale efficiently
• Common mistakes founders make when pitching investors and how to avoid them

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics.

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.

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.

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.

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.

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.

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:
🔹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.

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.

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.

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.

From early-stage planning to FDA engagement, we cover the decisions that make or break go-to-market timelines - and how emerging models are shaping the regulatory future.

🔥 What You’ll Learn:

• How to use FDA pre-submissions to clarify your path to approval

• What it takes to secure Breakthrough Designation - and why it matters

• The most common regulatory missteps made by startups

• How AI and direct-to-consumer models are shifting regulatory expectations

• What support MDSS provides to help startups navigate compliance

Whether you're a founder, operator, or innovator in diagnostics, this episode delivers clear, practical insights to help you build smarter - and faster.

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics.

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.

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.

With 24 years of experience in molecular diagnostics, Kimshares what it takes to build breakthrough science in a startup, scale it, and navigate the evolving challenges of today’s diagnostics landscape.

🔥 In This Episode, You’ll Learn:

 • How early-stage culture and leadership shape long-term innovation

• What it’s like to build diagnostics from scratch—then scale with impact

• Why commercialization and reimbursement strategy are non-negotiable

• What scientists and R&D leaders need to consider when joining startups vs. corporates

Whether you're scaling science, leading R&D, or enteringthe diagnostics field, Kim offers hard-earned insights for building a lasting career—and technology that truly matters.

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics.

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.

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.

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 candid conversation, Sam shares the hard truths about why diagnostics companies struggle for funding, why prognostics are quietly becoming the next frontier, and how early partnerships - especially with pharma, can make or break a startup.

With deep insights from his work in chronic kidney disease, Alzheimer’s, and early diagnostics ventures, this episode is essential listening for anyone building, backing, or navigating the Dx space.

🔥 What You’ll Learn:

• Why prognostic biomarkers are shaping the future of diagnostics

• How early-stage partnerships with pharma drive commercial success

• The biggest funding challenges facing Dx startups today

• What investors really want in a diagnostics pitch

Whether you're a founder, investor, or clinical innovator, Sam’s experience offers practical insight into the future of diagnostics, and what it takes to get there.

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics.

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.

We unpack the FDA’s recent ruling, and reversal on LDTs (Laboratory Developed Tests) and what this moment of uncertainty means for diagnostics startups.

Mort shares how to build a credible regulatory strategy that not only keeps you compliant but also supports your commercial goals and attracts investor confidence.

🔥 What You’ll Learn:

• How FDA’s LDT decision impacts diagnostics startups

• Why aligning regulatory with commercial strategy is critical

• What investors need to see in today’s uncertain regulatory climate

• How startups can stay credible and competitive through compliance

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics.

With a career spanning industry giants like Amgen and IonTorrent, Janine shares what it takes to lead in a fast-evolving space - where scalability, speed, and strategy matter more than ever.

We dive into how Pictor’s flexible platform is pushing proteomics toward its tipping point, why patient-centric design is critical, and how regulatory momentum is working in their favour.

🔥 What You’ll Learn:

• Why proteomics is the "new genomics" in diagnostics

• How Pictor is building a fast, scalable, and cost-effective platform

• The impact of recent regulatory changes on startup strategy

• How strong leadership and patient focus shape product success

🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of Diagnostics.

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.

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.

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.

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.

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.

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

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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

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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

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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/

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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.

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.