FDA plans public workshop on ctDNA tests

By LabPulse.com staff writers

February 14, 2020 -- The U.S. Food and Drug Administration (FDA) is planning to hold a public workshop on March 9 on the development of circulating tumor DNA (ctDNA) tests for cancer screening.

The workshop will explore clinical, scientific, and regulatory challenges associated with the development of ctDNA-based cancer screening tests. Also, stakeholders will discuss the study designs needed to show the safety, effectiveness, benefits, and risks of these tests.

Those interested must register with the FDA by 4 p.m. on March 2. Registrations will be accepted on a first-come, first-served basis. The deadline for written comments on the topic is April 6.


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