Life sciences tools and technologies company Promega announced that it has agreed to develop a companion diagnostic (CDx) for Incyte’s anti-PD-1 drug candidate retifanlimab in endometrial cancer. The diagnostic will be developed using Promega’s OncoMate microsatellite instability (MSI) Assay.
While financial terms of the CDx agreement were not disclosed, the two companies said they intend to work together in the future to develop the Promega OncoMate MSI Assay as a companion diagnostic in other markets.
“This announcement further underscores Promega’s dedication to advance the promise of MSI technology globally, building on over 20 years of expertise in this field,” said Heather Tomlinson, director of Clinical Diagnostics at Promega in a press release.
The OncoMate MSI Assay has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications and earlier this year received CE marking in Europe. Promega MSI technology is one of the leading standard tests for MSI status detection in research laboratories and achieved innovation status and priority review by the National Medical Products Administration (NMPA) in China. Promega intends to seek regulatory clearance for OncoMate™ MSI in the United States and China.
Microsatellite instability-high (MSI-H) is a key feature of Lynch syndrome tumors, indicative of a germline mutation in mismatch repair genes, but can also arise sporadically. It occurs frequently in endometrial cancer. The importance of the MSI-H biomarker has been further emphasized since the 2015 finding that MSI-H tumors have a prolonged and durable response to PD-1 inhibitors.