IVDR Reality Check: Compliance, Cost, and Challenges

More than an Itchy Bite! Diagnosing Mosquito-Borne Diseases

Mosquito season is here…and so are the diagnostic challenges.  Dr. Elitza Theel [https://www.linkedin.com/in/elitza-elli-theel-76301682/] 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 >> [https://www.buzzsprout.com/2515983/fan_mail/new]

Safety First! Real Stories from the Lab

Lab safety expert, Dan the Lab Safety Man [https://danthelabsafetyman.com/], 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 >> [https://www.buzzsprout.com/2515983/fan_mail/new]

Tick-Borne Disease Diagnostics: Beyond Lyme

Lyme disease is only part of the story.  In this episode, Dr. Kyle Rodino [https://www.linkedin.com/in/kyle-rodino-969a8223/] 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 >> [https://www.buzzsprout.com/2515983/fan_mail/new]

Women in Science, Speeding up PCR

In honor of the International Day of Women and Girls in Science, we’re joined by Heather Danks [https://www.linkedin.com/in/heather-e-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 >> [https://www.buzzsprout.com/2515983/fan_mail/new]

IVDR Reality Check: Compliance, Cost, and Challenges

In this episode of Diagnostics Decoded, we sat down with IVDR specialist Dr. Andreas Eckelt [https://www.linkedin.com/in/andreas-eckelt-1985404/] 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 >> [https://www.buzzsprout.com/2515983/fan_mail/new]