This week on Diagnosing Dx, I’m joined by James Kelley, Chief Medical Officer at Pictor Labs and a respected leader in lab medicine and diagnostics.

We explore how AI is reshaping pathology, what makes virtual staining such a transformative innovation, and why data ownership and transparency are becoming urgent conversations for clinicians. From regulatory frameworks to AI education in healthcare, this episode offers a sharp look at what’s ahead.

🔥What You’ll Learn:

• How virtual staining could transform pathology workflows

• Why data ownership matters in AI-powered diagnostics

• The current adoption curve and limitations of AI in lab medicine

• What healthcare professionals need to understand about AI today

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

This week on Diagnosing Dx, I’m joined by Vincent Funari, a genomics leader whose career spans from the Human Genome Project to pioneering liquid biopsy assays and driving innovation at NeoGenomics during its major growth years.

We dive into how Vincent scaled R&D through M&A, led testing innovation during the COVID-19 crisis, and earned praise from the FDA for breakthrough assay development.

He also reflects on his path from bench scientist to CSO,and what scientists need to know about making that leap.

🔥 What You’ll Learn:

• Why liquid biopsy and minimal residual disease (MRD) testing are redefining cancer diagnostics

• How NeoGenomics scaled through bold acquisitions and scientific vision and navigated Covid on the front line

• How FDA and Medicare recognition validated their novel assays

• What it takes to move from researcher to executive in life sciences - an insight for aspiring R&D leaders

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

On this week’s episode of Diagnosing Dx, I’m joined by Mort Minaee, a seasoned regulatory strategist with over 35 years of experience at companies like Roche, Abbott, and Guardant Health.

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.

This week on Diagnosing Dx, I’m joined by Janine McMurdie, Chief Commercial Officer at Pictor, a company unlocking the next wave of innovation in diagnostics through proteomics.

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.

This week on Diagnosing Dx, I’m joined by Dr. Sam Agus, a neurologist and diagnostics innovator with over 20 years of experience in clinical trials, biomarker development, and early-stage ventures.

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.

This week on Diagnosing Dx, we’re joined by Kim Langone, SVP of R&D at Fellow Health, and former 10th employee at Genomic Health, where for 19 years, she played a pivotal role in developing Oncotype DX, a landmark diagnostic test for breast cancer.

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.

This week on Diagnosing Dx, we’re joined by Heinz Steneberg, President and CEO of MDSS, for a deep dive into the role of Regulatory Strategy in Diagnostics and MedTech startups.

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.