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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