Diagnosing Dx

In this episode of Diagnosing Dx, David Filby is joined by Sivan Bercovici, Chief Technology Officer and Chief Business Officer at Karius.With more than two decades working at the intersection of computer science, AI and medicine, Sivan has spent over a decade helping build Karius' computational capabilities. In this conversation, we explore how AI is moving diagnostics beyond simply delivering test results towards providing meaningful clinical intelligence.Sivan explains how Karius has accumulated data from more than 150,000 cases, creating opportunities to identify patterns, improve diagnostic performance and help clinicians interpret increasingly complex information.We also discuss the shift from molecular intelligence to clinical decision support, the risks of over-reliance on AI, and why some of the world's most underserved healthcare systems could ultimately be among the fastest to benefit from it.Key takeaways:🔹 Why the future of diagnostics could extend beyond reporting molecular results🔹 How Karius is using data from 150,000 cases to advance diagnostic intelligence🔹 Why AI should support clinical decisions rather than replace physician judgement🔹 The challenges of regulation, reliability and systematic errors in medical AI🔹 Why underserved healthcare systems could potentially leapfrog more established marketsChapters:01:06 Introduction and Sivan Bercovici's background03:01 The origins of Karius and infectious disease liquid biopsy08:19 How AI in diagnostics has evolved11:26 Molecular intelligence and improving diagnostic accuracy15:01 Why access to 150,000 cases changes what's possible19:45 Moving from molecular results to clinical intelligence26:54 AI hype versus reality in healthcare32:27 Regulation, ethics and the future of AI-driven careGuest: Sivan Bercovici, PhDChief Technology Officer & Chief Business Officer, KariusLinkedIn: https://www.linkedin.com/in/sivanbercovici/Host: David FilbyFounder and CEO of Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/Learn more about Karius: https://kariusdx.com/🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Dr Oliver Bathe, Founder and CEO of Qualisure Diagnostics.After more than 25 years as a surgical oncologist, Oliver moved into diagnostics with a goal of helping clinicians make more precise treatment decisions. That work led to Thyroid GuidePx®, an 82-gene test designed to help identify whether papillary thyroid cancers are at higher or lower risk of recurrence.But the bigger opportunity goes beyond a single test. Oliver explains how Qualisure developed Molecular deCodeR™, a cloud-based platform designed to help deploy machine-learning-powered molecular diagnostics across laboratories globally without requiring every test to be run in one central lab.We also discuss decentralising precision oncology, building a transcriptomic foundation model, partnering with diagnostics and pharma companies, and why commercialisation has become the company’s next major focus.Key takeaways:🔹 Why many thyroid cancer patients may be treated more aggressively than necessary🔹 How Thyroid GuidePx® helps assess recurrence risk in papillary thyroid cancer🔹 Why centralised molecular testing can limit global access to precision oncology🔹 How Molecular deCodeR™ could enable diagnostic companies to deploy tests across multiple labs and markets🔹 Why Qualisure is building a foundation model to make transcriptomic diagnostics more reproducible across workflowsChapters:01:06 Introduction and Oliver Bathe’s background03:58 From cancer research to Qualisure Diagnostics05:29 The overtreatment problem in thyroid cancer08:26 Why precision oncology needs a decentralised model11:01 Molecular deCodeR™ and the bigger software opportunity13:18 Company milestones, partnerships and the $7M raise19:07 Commercialising the platform globally24:44 Building the next generation of transcriptomic diagnosticsGuest: Dr Oliver BatheFounder & CEO, Qualisure DiagnosticsProfessor of Surgery and Oncology, University of CalgaryLinkedIn: https://ca.linkedin.com/in/oliver-bathe-76a84636Host: 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.

In this episode of Diagnosing Dx, David Filby is joined by Ana Cornell, Founder and CEO of Acorn Genetics.Ana started Acorn after experiencing first-hand how expensive and inaccessible genomic testing could be. While studying biomedical engineering at Northwestern, she began developing lower-cost genomic analysis technology before being selected for the highly competitive Thiel Fellowship, which gave her the opportunity to leave university and build Acorn full-time.The company’s long-term goal is to decentralise genomic analysis, bringing testing out of central laboratories and making it dramatically more accessible.But the route to that goal hasn’t been conventional. When regulatory changes disrupted Acorn’s original clinical launch plans, the company pivoted its technology into brewing, agriculture and water testing, finding early product-market fit, generating revenue and continuing to develop its sequencing platform.Ana shares why revenue has become central to Acorn’s strategy, how the company is approaching profitability, and why she still sees decentralised genomic analysis as the ultimate destination.Key takeaways:🔹 Why Ana started Acorn Genetics after struggling to access genomic testing herself🔹 How Acorn is working to decentralise genomic analysis🔹 Why a regulatory roadblock led the company into brewing, agriculture and water testing🔹 How early revenue and customer feedback are helping fund the bigger sequencing vision🔹 Why Ana believes genomic analysis could eventually cost just dollars, or even penniesChapters:01:04 Introduction and Ana Cornell’s background02:31 The personal problem that led to Acorn Genetics07:14 From university research to the Thiel Fellowship13:42 Building Acorn and finding product-market fit18:20 Why agriculture became the route to early revenue21:29 The long-term vision for decentralised genomics25:00 Driving down the cost of genomic analysis28:03 Revenue, profitability and the milestones aheadGuest: Ana CornellFounder & CEO, Acorn GeneticsLinkedIn: https://www.linkedin.com/in/ana-cornell-53103a138/Host: David FilbyFounder and CEO of Elevra ConsultingLinkedIn: https://www.linkedin.com/in/davidfilby/Support Acorn GeneticsAcorn Genetics’ crowdfunding campaign is now open. Learn more and invest here:https://www.startengine.com/offering/acorn-genetics🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.

In this episode of Diagnosing Dx, David Filby is joined by Kavya Swaminathan, PhD, Co-Founder and CEO of Kascaid.An immunologist and proteomics scientist by training, Kavya has spent her career studying immune dysregulation and biomarker discovery. That experience led to Kascaid and a fundamental question: can we understand chronic immune disease better by measuring what is happening far more frequently?Kavya explains why the company is turning to interstitial fluid (ISF) as an alternative to traditional blood sampling, and how higher-frequency immune measurements could help clinicians understand treatment response, detect disease changes earlier and move away from today’s trial-and-error approach to care.We also discuss Kascaid’s plans for at-home sampling, its longer-term ambition to build a longitudinal immune data layer, and how partnerships with patients and clinicians are shaping the product from the earliest stages.Key takeaways:🔹 Why chronic immune disease needs more frequent and actionable biomarker data🔹 The limitations Kavya sees in conventional blood-based immune measurements🔹 Why interstitial fluid could enable higher-frequency monitoring🔹 How Kascaid is initially focusing on treatment response and disease progression🔹 Why longitudinal immune data could eventually support earlier diagnosis and more precise treatmentChapters:01:07 Introduction02:43 Kavya’s journey from immunology to diagnostics07:08 Kascaid and the chronic immune disease problem10:39 Why interstitial fluid instead of traditional blood testing?15:06 Monitoring treatment response more frequently19:26 Building a longitudinal immune data layer25:05 Company milestones, partnerships and early validation32:40 FDA, reimbursement and the path to marketGuest: Kavya Swaminathan, PhDCo-Founder & CEO, KascaidLinkedIn: https://www.linkedin.com/in/kavya-swaminathan/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.

In this episode of Diagnosing Dx, David Filby is joined by Paul Kase, Chief Commercial Officer at Lumos Diagnostics.Paul brings 30 years of healthcare experience, including more than 20 years in rapid point-of-care diagnostics. His history with FebriDx stretches back to its earliest development, and he now leads commercialisation as Lumos enters a major new phase following its US CLIA waiver. Paul explains how FebriDx uses two host-response biomarkers to help differentiate bacterial from non-bacterial infections from a finger-stick blood sample in around 10 minutes, without instrumentation.We also discuss antibiotic stewardship, reimbursement, integrating novel tests into existing clinical workflows, and the commercial strategy Lumos is using to drive adoption across urgent care and primary care. Key takeaways:🔹 Why the CLIA waiver represents such an important commercial milestone for FebriDx🔹 How CRP and MxA are used to differentiate bacterial from non-bacterial infection🔹 Why overlapping respiratory symptoms can contribute to unnecessary antibiotic prescribing🔹 The three pillars Paul believes every novel point-of-care diagnostic needs to address🔹 How Lumos is approaching reimbursement, distribution and adoption in the USChapters:01:07 Introduction and Paul Kase’s background05:43 Lumos Diagnostics and the FebriDx CLIA waiver08:03 How FebriDx works and the unmet need09:54 Changing the respiratory testing workflow14:27 Clinical utility, workflow and reimbursement20:21 Commercialisation, adoption and distribution25:14 International expansion and future markets30:53 Future milestones and driving commercial growthGuest: Paul KaseChief Commercial Officer, Lumos DiagnosticsLinkedIn: https://www.linkedin.com/in/paul-kase-8bb96159/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.

In this episode of Diagnosing Dx, David Filby is joined by Marty Keiser, Founder and CEO of IVBH. After beginning his career in asset management and capital markets, Marty moved into biotech eight years ago with a focus on blood-based molecular diagnostics and early disease detection. That outside perspective shaped how he built IVBH, borrowing ideas from industries beyond diagnostics to create a different model for developing and scaling diagnostic companies. Marty explains IVBH’s studio model, the science behind its cell-free RNA platform, and how its health franchises are developing tests across breast cancer, lung cancer and metabolic liver disease.We also discuss why traditional diagnostics business models can struggle, the growing opportunity for cash-pay and consumerised testing, and what helped Mammogen secure institutional Series A funding in a difficult market.Key takeaways:🔹 Why Marty believes the traditional diagnostics business model needs to evolve🔹 How IVBH uses a central discovery platform to build multiple health franchises🔹 Why cell-free RNA could offer advantages for earlier disease detection🔹 How LDTs, cash-pay models and new diagnostic “storefronts” could reshape commercialisation🔹 What investors looked for when Mammogen raised its Series AChapters:01:02 Introduction and Marty Keiser’s background03:22 Moving from capital markets into diagnostics08:20 Building the IVBH business model differently11:27 Surviving the biotech downturn and changing capital markets16:09 The science behind IVBH’s cell-free RNA platform20:06 LDTs, cash-pay testing and new commercial models26:13 What helped Mammogen secure its Series A30:26 Future milestones and rethinking diagnostics growthGuest: Marty KeiserFounder & CEO, IVBHLinkedIn: https://www.linkedin.com/in/martykeiserHost: 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.

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 ambitionsChapters:00:59 Introduction and Raymond Tarr’s background05:46 Moving from diagnostics into rare disease08:57 The personal experience behind Sagacity Diagnostics11:00 How PathfindEHR works17:49 Using EHR data to identify patients who need testing23:16 How diagnostics companies can benefit from the platform29:16 Commercialisation and early market traction34:40 Future milestones and scaling SagacityGuest: Raymond TarrFounder, Sagacity DiagnosticsLinkedIn: https://www.linkedin.com/in/raymondtarr/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.

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 scienceChapters:00:56 Introduction and Robert Carlson’s background05:40 Why partnerships matter in early-stage diagnostics12:19 Using partnerships to strengthen fundraising14:51 Why founders hesitate to partner early19:29 IP, control and the fear of being locked in25:29 Why great science alone isn’t enough28:43 Reimbursement, regulatory strategy and investor expectations35:18 Building the right commercial strategy from the startGuest: Robert CarlsonFounder and President, Life Science Dx ConsultingLinkedIn: https://www.linkedin.com/in/robertwcarlsonsr/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.

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 timelinesChapters:01:02 Introduction and Octavian Florescu’s background04:32 From microchip design to blood testing06:33 Lessons from his first diagnostics company11:20 Building In Diagnostics as a minimum viable company13:52 Microchip-based blood testing and the unmet need for more data19:15 Launching first in veterinary diagnostics22:27 Building towards profitability without traditional VC funding29:53 Upcoming milestones and the future of diagnosticsGuest: Octavian FlorescuCEO, In DiagnosticsLinkedIn: https://www.linkedin.com/in/octavian-florescu-51b28817/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.

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 adoptionChapters:00:57 Introduction and Nicole Bell’s background02:43 The personal story behind Nicole’s move into vector-borne diagnostics08:17 Why vector-borne infections are so difficult to diagnose13:28 Galaxy Diagnostics and its direct detection approach17:22 How widespread is the vector-borne disease problem?22:05 Commercialisation, clinical studies and the path to FDA approval27:13 Raising a Series A in a difficult diagnostics market31:31 Upcoming milestones and the future of diagnosticsGuest: Nicole BellCEO, Galaxy DiagnosticsLinkedIn: https://www.linkedin.com/in/nicoledaniellebell/Learn more about Galaxy Diagnostics: https://www.galaxydx.com/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.