Oversight of Laboratory Developed Tests: What We've Learned

Interim CEO of ASCP and host Dr. Ali Brown sits down with Dr. Eric Konnick and Michelle Campbell, MLS(ASCP) to discuss lessons learned from the latest efforts to place laboratory developed tests under FDA oversight. For listeners unfamiliar with LDTs, they begin by establishing what LDTs are and what their value to the lab and patient safety are before debunking common misunderstandings cited by patient advocacy groups regarding their accuracy, validity, and the transparency with which they’re developed. They go on to define what FDA oversight would mean for laboratories in terms of cost, time, and labor, contextualizing these added costs in ongoing workforce shortages in the lab. They close their conversation by spotlighting which efforts ASCP and similar organizations made to advocate for the lab were most successful, and describe alternative strategies for updating laboratory regulations, such as modernizing CLIA.