FDA Approves FoundationOne CDx as a Companion Diagnostic for Merck’s Keytruda

Cambridge, Mass.-based Foundation Medicine has received FDA’s approval for use of its tissue-based genomic profiling test, FoundationOne CDx, as a companion diagnostic to identify cancer patients for treatment with Merck’s Keytruda (pembrolizumab).

The test can identify patients with microsatellite instability high (MSI-H) solid tumors, which are commonly found in colorectal, endometrial and gastrointestinal cancers. In this type of tumor, the DNA repair mechanisms are faulty, so tumor cells can acquire a significant number of mutations.

The FoundationOne CDx approval “underscores an important shift toward tumor-agnostic cancer care,” said Mia Levy, Foundation Medicine’s chief medical officer. Tumor-agnostic therapy is based on a cancer’s genetic or molecular features rather than the cancer type.