Foundation Medicine Companion Diagnostic Test Approved

The FDA has approved Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic to identify patients with ROS1-positive nonsmall-cell lung cancer or patients with NTRK fusion-positive solid tumors who don’t have tissue samples available and who are eligible for treatment with Genentech’s Rozlytrek (entrectinib).

The FoundationOne Liquid CDx blood test analyzes more than 300 cancer-related genes for genomic alterations that lead to cancer growth, the company said.

The liquid companion diagnostic is now approved for nine targeted therapies, Foundation Medicine said.

The agency previously approved the company’s Foundation One CDx tissue-based test in 2022.