- Home
- Advocacy
- Latest News and Practice Data
- CAP Meets with Top FDA Officials to Discuss COVID-19 Testing
The Food and Drug Administration’s (FDA) leadership convened the meeting on March 1 to update the laboratory community on the current state of their COVID-19 activities. Acting FDA Commissioner Janet Woodcock, MD, and Jeff Shuren, MD, Director of the Center for Device and Radiological Health reinforced that career officials would make regulatory determinations based on science not politics.
CAP President Patrick Godbey, MD, FCAP, President-elect Emily Volk, MD, FCAP, and Jonathan Myles, MD, FCAP, who serves as chair of the Council on Government and Professional Affairs, represented the CAP. The CAP leaders, on behalf of pathologists, discussed several issues, which included the agency’s regulatory policy for laboratory-developed tests. Following a question from the CAP, the FDA officials said the agency would not make significant policy changes without sharing guidance and information with the laboratory community.
On the topic of reporting cycle threshold values, the meeting participants discussed limitations when reporting these values because of difficulties comparing different tests and platforms diagnosing COVID-19. The CAP has developed an FAQ document on cycle threshold values.
The CAP also raised with the FDA persistent problems with obtaining diagnostic supplies for COVID-19 tests and will remain engaged with agency officials to solve issues laboratories are encountering during the pandemic.