21 February 2022 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now the first and only FDA approved companion diagnostic to aid in identifying patients with MSI-H solid tumours who may benefit from immunotherapy.

Foundation Medicine today announced that it received approval from the U.S. FDA for FoundationOne CDx to be used as a companion diagnostic to identify patients with microsatellite instability high status solid tumours who may be appropriate for treatment with Merck’s Keytruda (pembrolizumab).