Diagnostics Decoded by ZeptoMetrix

Can pregnant patients collect their own samples for Group B Streptococcus screening without compromising test performance? Dr. Aloysus Lawong of Parkland Memorial Hospital joins Diagnostics Decoded to discuss his work of validating self-collected specimens for molecular GBS testing.Dr. Lawong breaks down the study’s design, discrepancies, technical challenges, and implementation in prenatal clinics. The conversation also explores the importance of the preanalytical phase, the regulatory implications of modifying an FDA-cleared assay, and how self-collection could give patients greater autonomy, streamline clinical workflows, and expand access to prenatal care.Like this episode? Text us your thoughts >>

What happens when engineering, genetics, and medicine converge? Dr. Elena Repnikova joins Diagnostics Decoded to explore the rapidly evolving world of clinical genetics and molecular diagnostics. From her research background in genetics to her leadership role at Children’s Mercy in Kansas City, Missouri, Dr. Repnikova discusses how laboratories support prenatal, pediatric, and oncology patients through advanced genetic testing. The conversation covers diagnostic workflows, whole genome and exome sequencing, bioinformatics, diagnostic stewardship, actionable cancer mutations, and emerging technologies like rapid intraoperative nanopore sequencing. Dr. Repnikova also shares her perspective on the future of genetic testing, the challenges behind rare disease diagnosis, and why precision medicine continues to transform healthcare. Like this episode? Text us your thoughts >>

Congenital cytomegalovirus (CMV) is the most common congenital infection worldwide, yet awareness is surprisingly low. We’re joined by Dr. Kaisha Gonzalez, Scientific Affairs Director at Diasorin, to unpack the complex spectrum of congenital CMV: from transmission during pregnancy to diagnostic challenges and long-term outcomes in newborns.Like this episode? Text us your thoughts >>

Mosquito season is here…and so are the diagnostic challenges. Dr. Elitza Theel of the Mayo Clinic joins us to discuss how clinicians and laboratories approach mosquito-borne diseases, with insights on symptom overlap, test selection, timing, and key pathogens seen in North America. Like this episode? Text us your thoughts >>

Lab safety expert, Dan the Lab Safety Man, shares practical guidance on building an effective lab safety program, avoiding common mistakes, and strengthening safety culture to protect both staff and patients.Like this episode? Text us your thoughts >>

Lyme disease is only part of the story. In this episode, Dr. Kyle Rodino joins us to explore the expanding world of tick-borne pathogens, the diagnostic challenges laboratories face, and how molecular innovation, LDTs, and emerging technologies may shape the next decade of testing.Like this episode? Text us your thoughts >>

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 Like this episode? Text us your thoughts >>

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. Like this episode? Text us your thoughts >>

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 engineeredIts impact on PCR, multiplex assays, and point-of-care testingOpportunities in RNA-based diagnostics and research, metagenomics, and transcriptomicsHow PLP supports rapid response during emerging outbreaksLike this episode? Text us your thoughts >>

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 performanceWhy understanding assay resolution and lot-to-lot variability is criticalThe consequences of insufficient validationThe growing role of AI and point-of-care testing in diagnostics Like this episode? Text us your thoughts >>