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Promega to Develop MSI Assay as CDx for Incyte Endometrial Cancer Drug

NEW YORK – Promega said on Tuesday that it has agreed to develop its OncoMate microsatellite instability (MSI) assay as a companion diagnostic test for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer in the US.

Financial terms of the agreement were not disclosed.

OncoMate MSI is a PCR assay that measures microsatellite instability status in tissue samples from solid tumors. The assay received CE marking in June. Promega said it intends to seek regulatory clearance for the assay in the US 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. Its importance as a biomarker was underscored by the 2015 finding that MSI-H tumors have a prolonged and durable response to PD-1 inhibitors.

Promega and Incyte said that they intend to work together in the future to develop the OncoMate MSI Assay as a companion diagnostic in other geographical markets.