NEW YORK – Promega said Tuesday that it is working to develop and commercialize a microsatellite instability companion diagnostic IVD kit with GlaxoSmithKline intended to identify adult cancer patients with MSI-high solid tumors who may be eligible for potential treatment with the pharma firm's anti-PD-1 monoclonal antibody drug Jemperli (dostarlimab-gxly).
Jemperli received accelerated approval from the US Food and Drug Administration in August 2021 for patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by a US Food and Drug Administration-approved test. According to Promega, the development of this new CDx IVD kit — which will use Promega's PCR-based five-marker MSI panel — is part of GSK's post-marketing commitment to the FDA to make a companion diagnostic available to support the drug's use.
Financial terms of the deal were not disclosed.
Promega said that its PCR method has been used extensively in clinical research around the world and is supported by hundreds of peer-reviewed publications across 25 different cancer types. The company's OncoMate MSI Dx Analysis System has already been cleared by the FDA as an IVD medical device to determine MSI status in colorectal cancer. The platform is CE-marked and has received innovation status and priority review by the NMPA in China, where Promega also intends to seek regulatory clearance for its MSI IVD.