In honor of the International Day of Women and Girls in Science, we’re joined by Heather Danks, PhD, CTO of LEX Diagnostics.

Dr. Danks shares her journey from genetics and academia to her role helping to build a novel, ultra-rapid PCR platform designed for point-of-care testing. We dive into the science and team behind LEX’s VELO system, lessons learned along the way, and her advice for the next generation of women in STEM.

Tune In to Learn About:

• What inspired Heather’s path from genetics research to diagnostics product development
• How LEX is working to bring ultra-rapid PCR to the point of care, with results in under 10 minutes
• Why ease of use matters for real-world clinical settings beyond traditional labs
• What it takes to build a regulated diagnostic product: from the technology, to the workflow, to the team
• Dr. Danks’ guidance for young women exploring STEM careers (and why it’s okay to pivot

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In this episode of Diagnostics Decoded, we sat down with IVDR specialist Dr. Andreas Eckelt to break down the rapidly evolving landscape of in vitro diagnostic regulations in the EU. Tune in to hear what distinguishes IVDR from the former IVDD, why the updated requirements can be challenging for smaller companies and labs, and how to prepare for audits.

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Phage-like particle (PLP) technology is reshaping how the diagnostics field approaches RNA controls, and this episode explores the story behind it. Hosts Dr. Sophie New, PhD, and Richard Keitch talk with Dr. Murugan Subbiah, DMV, MS, PhD, DACVM, Principal Scientist at ZeptoMetrix, about the real-world challenges that sparked the development of PLP, from avian flu outbreaks to COVID-19.

He breaks down how PLP enables labs to access safe, stable, non-infectious RNA controls quickly and reliably.

Tune In to Learn About:

• What PLP is and how it’s engineered
• Its impact on PCR, multiplex assays, and point-of-care testing
• Opportunities in RNA-based diagnostics and research, metagenomics, and transcriptomics
• How PLP supports rapid response during emerging outbreaks

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Join Diagnostics Decoded host Dr. Sophie New, PhD for an in-depth conversation with Dr. Radhakrishnan Gnanasambandam, PhD, and Brandon Hoelcle on the science, math, and puzzle-solving behind assay development, and reveal the most common pitfalls they see along the way.

Tune in to hear:

• How early collaboration drives stronger assay performance
• Why understanding assay resolution and lot-to-lot variability is critical
• The consequences of insufficient validation
• The growing role of AI and point-of-care testing in diagnostics

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In our debut episode of Diagnostics Decoded, Dr. Sophie New (Business Development Manager at ZeptoMetrix) sits down with Andrew Zenger (Global Product Manager) and Dr. Jessica Van Allen (Technical Support Lead) to explore the evolving world of diagnostics.

They discuss how diagnostic tools are shaping global health, the transformative impact of the post-pandemic landscape, and what the future holds for the field. Packed with valuable insights, this episode provides an in-depth look at the challenges, innovations, and opportunities driving diagnostics today.

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