Foundation Medicine Diagnostic Approved for Bile Duct Cancer Patients

The FDA expanded its approval of Foundation Medicine’s FoundationOne CDx (F1CDx) laboratory test to include a gene linked to bile duct cancer.

The approval expands the indications to include bile duct cancer patients with genetic variations in the FGFR2 gene. The test will help determine if the patients qualify for surgery or should be treated with Pemazyre (pemigatinib).

The companion diagnostic that was originally approved for the detection of genetic variations in patients who may be eligible for treatment with one of fifteen FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer.