Next steps. FDA is now accepting “statements of interest” to apply for the oncology companion diagnostic pilot program, which may be submitted alongside a sponsor’s Investigational New Drug ...

The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only ...

The US Food and Drug Administration (FDA) plans to phase out its general enforcement discretion policy for LDTs over a four-year period, with the first phase of its final rule on LDTs due to come ...

Attorneys said many questions remain about the regulation of laboratory developed tests after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical devices.

A district court ruling asserts that the FDA does not have responsibility for the ... regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs).

Tests Subject to FDA’s Final Phaseout Policy “IVDs offered as LDTs” “IVDs that are manufactured and offered as LDTs” by high-complexity laboratories that are certified under the Clinical ...

Guardant Health, Inc., a leading precision oncology company, announced today that the U.S. Food and Drug Administration has approved its Guardant360 ® CDx liquid biopsy test as a companion ...

"FDA’s LDT rule struck down in Texas court" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith ...