FDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Conor Hale
Conor Hale

YOU MAY BE INTERESTED IN

More than half of deaths that are not attributed to disease progression or recurrence after CAR T-cell therapy are caused by infections—an unprecedented finding that experts say marks a shift from a conventional focus on mitigating treatment-specific adverse events to including prevention and management of infections.
Conor Hale
Conor Hale

Login