FDA approves Promega cancer test for Keytruda use

The U.S. Food and Drug Administration has approved Promega's OncoMate MSI Dx Analysis System as a companion diagnostic for Keytruda in microsatellite instability-high solid tumors.

Promega said the PCR-based assay is designed to evaluate MSI status in solid tumor tissue, which can help inform treatment decisions in precision oncology. Keytruda is Merck's anti-PD-1 therapy.

Promega said the approval was supported through a collaboration with Merck. Alok Sharma, Promega's global clinical market director, said the test was intended to connect patients with a therapy most likely to help them.

The company said OncoMate MSI Dx had previously been cleared by the FDA as a PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. It is also approved as a companion diagnostic for identifying patients with microsatellite stable endometrial carcinoma who may benefit from Keytruda plus Lenvima.

Promega said the U.S. approvals apply to the United States and its territories. It also said its MSI technology is CE-marked in the European Union and approved by China's National Medical Products Administration as a companion diagnostic for identifying patients with MSI-H solid tumors who may benefit from Keytruda.