BioCentury
ARTICLE | Regulation

Label expansions coming at a rapid clip for Foundation’s blood-based companion cancer diagnostic 

November 10, 2020 3:48 AM UTC

In the past three weeks, FDA has added four companion diagnostic indications to the label of Foundation Medicine’s liquid biopsy test, growing the number of genetic biomarkers indicated for matching patients to targeted therapies.

The label expansions double the use cases for the FoundationOne Liquid CDx test from the Roche unit, and come less than four months after the agency granted its first set of approvals. The test uses next-generation sequencing to detect mutations in cell-free DNA in blood samples...