Diagnosing Dx

What If the Patients Who Need Your Test Are Already Hiding in the EHR? Sagacity Diagnostics

In this episode of Diagnosing Dx, David Filby is joined by Raymond Tarr, Founder of Sagacity Diagnostics. Raymond brings more than 25 years of experience across diagnostics, rare disease, commercialisation and patient finding, with previous roles spanning companies including Cepheid and AstraZeneca/Alexion. His experience in rare disease, both professionally and personally, ultimately led to the creation of Sagacity Diagnostics and its PathfindEHR platform. Raymond explains how PathfindEHR is designed to help clinicians identify patients who may be undiagnosed, misdiagnosed or missing the right testing by making better use of data already sitting within electronic health records. We also discuss the adoption challenge facing diagnostics companies, how better workflow integration could drive more appropriate testing, and why education and awareness can be just as important as developing the test itself. Key takeaways: 🔹 Why existing EHR data could help shorten the diagnostic journey 🔹 How PathfindEHR helps identify suspect and potentially misdiagnosed patients 🔹 Why better workflow integration can increase appropriate diagnostic testing 🔹 How diagnostics companies can benefit from stronger clinician education and adoption tools 🔹 Why rare disease is only the starting point for Sagacity’s wider ambitions Chapters: 00:59 Introduction and Raymond Tarr’s background 05:46 Moving from diagnostics into rare disease 08:57 The personal experience behind Sagacity Diagnostics 11:00 How PathfindEHR works 17:49 Using EHR data to identify patients who need testing 23:16 How diagnostics companies can benefit from the platform 29:16 Commercialisation and early market traction 34:40 Future milestones and scaling Sagacity Guest: Raymond Tarr Founder, Sagacity Diagnostics LinkedIn: https://www.linkedin.com/in/raymondtarr/ 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.

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Can Strategic Partnerships Save Diagnostics Innovation? Robert Carlson

In this episode of Diagnosing Dx, David Filby is joined by Robert Carlson, Founder and President of Life Science Dx Consulting. Robert brings 30 years of experience across diagnostics and life sciences, spanning scientific, commercial, corporate development and executive leadership roles. He explains why early-stage diagnostics companies should think about partnerships much earlier, not only as a source of funding but as a way to build credibility, strengthen commercial strategy and create new routes to market. The conversation also covers reimbursement, market access, investor expectations and why strong science alone is rarely enough to build a successful diagnostics company. Key takeaways: 🔹 Why diagnostics founders should consider partnerships before they urgently need them 🔹 How strategic partnerships can strengthen a future fundraising story 🔹 Why fear around IP, dilution and losing control can hold founders back 🔹 The importance of understanding reimbursement and market access early 🔹 Why commercial strategy should develop alongside the science Chapters: 00:56 Introduction and Robert Carlson’s background 05:40 Why partnerships matter in early-stage diagnostics 12:19 Using partnerships to strengthen fundraising 14:51 Why founders hesitate to partner early 19:29 IP, control and the fear of being locked in 25:29 Why great science alone isn’t enough 28:43 Reimbursement, regulatory strategy and investor expectations 35:18 Building the right commercial strategy from the start Guest: Robert Carlson Founder and President, Life Science Dx Consulting LinkedIn: https://www.linkedin.com/in/robertwcarlsonsr/ 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.

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Could More Frequent Blood Testing Transform How We Detect Disease?

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: 🔹 Why Octavian believes blood testing should become more frequent and accessible 🔹 How lessons from his first diagnostics company shaped In Diagnostics 🔹 Why the veterinary market offers an early route to revenue and product validation 🔹 The thinking behind building a two-person “minimum viable company” 🔹 Why diagnostics funding may need to move beyond traditional venture timelines Chapters: 01:02 Introduction and Octavian Florescu’s background 04:32 From microchip design to blood testing 06:33 Lessons from his first diagnostics company 11:20 Building In Diagnostics as a minimum viable company 13:52 Microchip-based blood testing and the unmet need for more data 19:15 Launching first in veterinary diagnostics 22:27 Building towards profitability without traditional VC funding 29:53 Upcoming milestones and the future of diagnostics Guest: Octavian Florescu CEO, In Diagnostics LinkedIn: https://www.linkedin.com/in/octavian-florescu-51b28817/ 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.

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Why Are Vector-Borne Infections Still So Difficult to Diagnose?

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: 🔹 Why Lyme, Bartonella and Babesia can be particularly difficult to detect 🔹 The limitations of relying on antibody testing for active infection 🔹 Why vector-borne disease exposure extends far beyond obvious tick bites 🔹 How Galaxy Diagnostics is approaching direct pathogen detection 🔹 The company’s path towards FDA approval, reimbursement and broader adoption Chapters: 00:57 Introduction and Nicole Bell’s background 02:43 The personal story behind Nicole’s move into vector-borne diagnostics 08:17 Why vector-borne infections are so difficult to diagnose 13:28 Galaxy Diagnostics and its direct detection approach 17:22 How widespread is the vector-borne disease problem? 22:05 Commercialisation, clinical studies and the path to FDA approval 27:13 Raising a Series A in a difficult diagnostics market 31:31 Upcoming milestones and the future of diagnostics Guest: Nicole Bell CEO, Galaxy Diagnostics LinkedIn: https://www.linkedin.com/in/nicoledaniellebell/ Learn more about Galaxy Diagnostics: https://www.galaxydx.com/ 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.

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What Can Diagnostics Founders Learn From Two Successful Exits? Andrew Miller

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: 🔹 What Andrew learned from two successful diagnostics exits 🔹 Why Ionian chose acquisition rather than funding the full journey to FDA approval 🔹 How the lessons from his first exit shaped NAT Diagnostics from day one 🔹 Why founders need to prepare for due diligence long before an acquisition process begins 🔹 The four risks Andrew uses to assess early-stage diagnostics companies Chapters: 00:00 Introduction and Andrew Miller’s background 02:23 Two diagnostics exits and the opportunity in rapid molecular testing 04:03 Building Ionian Technologies 08:37 Why Ionian pursued an acquisition 15:00 Building NAT Diagnostics differently the second time 19:04 Designing a diagnostics company for acquisition 27:03 Advising founders and the four risks every startup faces 31:33 Where diagnostics is heading next Guest: Andrew Miller, PhD Diagnostics Founder, Advisor & Two-Time Exited CEO LinkedIn: https://www.linkedin.com/in/andrew-miller-2670811/ 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.

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98% of Cancer Patients Outside the US Miss Genomic Testing. Can AI Change That?

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: 🔹 Why access to genomic testing remains extremely limited outside the US 🔹 How Imagenomix uses AI to identify mutation signals from standard H&E pathology images 🔹 Why AI screening could reduce the cost and volume of unnecessary NGS testing 🔹 How digital pathology partnerships could help Imagenomix scale globally 🔹 Why predicting treatment response could become the next major step for AI in precision oncology Chapters: 00:59 Introduction and Travis Wold’s background 05:29 From cancer diagnostics to the global genomic testing problem 09:42 The limitations of NGS and where AI fits into the workflow 13:36 Imagenomix’s mission and the 98% genomic testing gap 17:42 Funding, digital pathology partnerships, and commercial traction 20:36 Regulatory strategy, screening, and the path towards companion diagnostics 23:13 Can AI predict which cancer patients will respond to treatment? 32:56 Scaling Imagenomix globally and the milestones ahead Guest: Travis Wold Chief Executive Officer at Imagenomix LinkedIn: https://www.linkedin.com/in/travisjwold/ 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.

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Could 20-Minute Hormone Testing Transform Patient Care? Nedal Safwat, SVP at Canatu

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: 🔹 Why Canatu is bringing carbon nanotube technology into medical diagnostics 🔹 Why hormone testing and sepsis were selected as the company’s first focus areas 🔹 Why diagnostics companies should start with the unmet need and work backwards 🔹 How point-of-care hormone testing could improve convenience and reduce patient drop-off 🔹 Why reimbursement, cost and customer validation need to be considered from the beginning Chapters: 00:53 Introduction and Nedal Safwat’s background 07:18 Canatu and the move into medical diagnostics 13:02 Why hormone testing and sepsis? 17:26 Starting with the unmet need and product-market fit 21:29 Partnerships, personalised hormone testing and patient demand 27:52 Product development and the path to commercialisation 32:57 Reimbursement, design-to-cost and startup culture 40:30 Future milestones and the diagnostics market outlook Guest: Nedal Safwat Senior Vice President, Medical Diagnostics at Canatu President, Canatu Inc. LinkedIn: https://www.linkedin.com/in/nedal-safwat/ Learn more about Canatu, Medical Diagnostics here: https://canatu.com/products/medical-diagnostics/ 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.

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Could a $127M Seed Round Change Women's Health Forever? - Dean Remy, Co-Founder @ Mativa Dx

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: 🔹 Why the traditional pregnancy test does not provide women with enough early information 🔹 How Mativa plans to identify risks such as ectopic pregnancy and pre-eclampsia 🔹 Why a longitudinal maternal biorepository could transform diagnostics and therapeutic development 🔹 How retail, healthcare, pharmaceutical, and diagnostic partnerships could accelerate adoption 🔹 Why supporting the complete patient journey could define the next generation of diagnostics Chapters: 01:08 Introduction and Dean Remy’s background 03:24 Why maternal health urgently needs innovation 06:28 Mativa’s approach and the technology behind the platform 11:42 Building a comprehensive maternal biorepository 14:24 Commercial strategy and market positioning 17:13 Regulatory and reimbursement pathways 20:18 Capital raising and strategic partnerships 25:34 The future of Mativa and maternal diagnostics Guest: Dean Remy Co-Founder and Chief Commercial Officer at Mativa Diagnostics LinkedIn: https://www.linkedin.com/in/scisourceremy/ 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.

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Red Drop’s Bet on Pain-Free Blood Collection and the Next Wave of Diagnostics

In this episode of Diagnosing Dx, David Filby is joined by Thomas Briggs, Chief Growth Officer at RedDrop Dx. Thomas brings more than 25 years of diagnostics and healthcare growth experience, spanning pharma, big diagnostics, medtech, and startup environments. In this conversation, we explore one of the most overlooked parts of diagnostics: blood collection, and why the process still looks far too similar to what it did decades ago. Thomas breaks down where arm-based micro-sampling could genuinely change patient experience, from paediatrics and neurodivergent patients to home testing, clinical trials, and difficult vein access. 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. Key takeaways: 🔹 Why blood collection remains one of the least-innovated parts of diagnostics 🔹 Where arm-based micro-sampling could have the biggest clinical and commercial impact 🔹 Why paediatrics, neurodivergent patients, and difficult vein access are such important use cases 🔹 How home sampling could change clinical trials, routine monitoring, and direct-to-consumer care 🔹 What it takes to commercialise a medtech product in both consumer and managed-care settings Chapters: 01:51 Thomas Briggs’ background in diagnostics, pharma, and medtech 06:28 Moving from big corporates into startups 11:04 What RedDrop Dx is building and how the device works 14:39 Where the biggest commercial opportunities are for arm-based micro-sampling 18:48 Why education and awareness are still a major challenge 21:22 RedDrop Dx’s story so far and why it was bootstrapped 26:05 How the company is building for growth across different market segments 30:10 Future milestones, home collection clearance, and expansion into Europe 31:31 Thomas’s outlook on diagnostics, home testing, and micro-sampling in 2026 Guest: Thomas Briggs Chief Growth Officer at RedDrop Dx LinkedIn: https://www.linkedin.com/in/thomas-briggs-959865177/ 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.

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Why Cancer Patients Still Die From Infections We Can't Diagnose - Karius

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 🔹 How Karius is using microbial cell-free DNA to diagnose infection from a simple blood draw 🔹 Why focus and disciplined market selection have been central to Karius’ growth 🔹 How physician confidence and education shape adoption of new diagnostics 🔹 Why outpatient infectious disease testing could become a major next step for the field Chapters: 01:00 Introduction and Alec Ford’s background 04:20 Transition from therapeutics to genomics 08:34 The founding story of Karius and how the technology works 14:52 Why Karius focused on immunocompromised patients 19:41 Scaling the company and driving adoption 27:20 Reimbursement, capital strategy, and path to profitability 34:40 The outpatient opportunity and Karius’ next chapter 45:03 Alec’s view on the diagnostics industry and what needs to change Guest: Alec Ford Chief Executive Officer at Karius LinkedIn: https://www.linkedin.com/in/alec-ford-b578003/ Host: David Filby Founder and CEO of Elevra Consulting LinkedIn: https://www.linkedin.com/in/davidfilby/ Learn more about Karius here: https://kariusdx.com/ 🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

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Can AI Rescue Cancer Drugs That Clinical Trials Say Have Failed?

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 🔹 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.

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What If We Could Test Depression Drugs Before Patients Take Them? Dr Talia Cohen Solal - NeuroKaire

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

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Why AI Multiomics Will Replace Ultrasound in Liver Cancer Screening with Bharat Tewarie

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: 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.

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Start with Reimbursement and Work Backwards - Jonathan Romanowsky

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

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

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

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

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

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

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.