Promega has scored an FDA green light for its microsatellite instability testing technology as a companion diagnostic for Merck and Eisai’s Keytruda-Lenvima combination for patients with advanced endometrial carcinoma.
The company’s platform will be used to help identify patients with microsatellite stable (not MSI-high) endometrial carcinoma who may benefit from treatment with the combination therapy, Promega announced Nov. 11.
Endometrial cancer is the most common form of uterine cancer and the fourth most common cancer for women in the U.S., according to the American Cancer Society.
Promega’s diagnostic platform is a PCR-based assay designed to evaluate MSI (microsatellite instability) status in tumors by measuring the ability of a cell to repair mistakes in DNA replication.
MSI status has been found to be a biomarker for response to immunotherapy, and Promega has been working with Merck since 2019 to develop the technology into a companion diagnostic for its immunotherapy blockbuster Keytruda in solid tumors.
“This approval underscores the critical role diagnostics play in accurately matching the right patients at the right time with the right therapy,” Promega Global Clinical Market Director Alok Sharma, Ph.D., said in a statement. “We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes.”
Although this is the Madison, Wisconsin-based company’s first FDA approval for a companion diagnostic, its testing methods have been around for decades.
Promega produced the first commercially available kit for researching MSI in 2004, and its OncoMate MSI Dx platform received FDA clearance in 2021 to identify colorectal cancer patients who may benefit from additional testing for Lynch syndrome. The technology has also won regulatory approvals in China and the EU.