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Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug

NEW YORK — Promega said on Thursday that it has signed an agreement to work with Chinese biopharmaceutical firm Henlius Biotech on the development and commercialization of a microsatellite instability, or MSI, companion diagnostic for an investigational cancer drug.

Under the terms of the deal, the companies will use Promega's multiplex PCR-based technology for MSI status detection to develop a test that can identify patients likely to benefit from serplulimab, an anti-PD-1 monoclonal antibody developed by Henlius for MSI-high solid tumors that is currently under review by Chinese regulators.

Additional terms were not disclosed.

Last month, the US Food and Drug Administration cleared Promega's OncoMate MSI Dx Analysis System for use in screening for Lynch syndrome in colorectal cancer patients. In late 2020, the Madison, Wisconsin-based company agreed to develop the system as a companion diagnostic test for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.