Promega to Develop Microsatellite Instability (MSI) Companion Diagnostic IVD Kit in Collaboration With GSK
–Promega Corporation today announced it plans to develop and commercialize a microsatellite instability (MSI) companion diagnostic (CDx) IVD kit with GSK to identify adult cancer patients with MSI-H solid tumors who may be eligible for potential treatment with GSK’s Jemperli (dostarlimab-gxly). The collaboration agreement leverages the companies’ complementary strengths to expand personalized healthcare options to more patients using high quality diagnostic tools and treatments.
This collaboration underscores our commitment to enabling patient access to targeted therapies,” says Alok Sharma, Global Clinical Market Director at Promega. “The results of our MSI biomarker test will be a critical step to identifying patients who may be eligible to receive this drug marketed by GSK.”
The future CDx indication under development will utilize the Promega PCR-based five-marker MSI panel with Jemperli, an anti-PD-1 monoclonal antibody (mAb). Jemperli is currently approved for patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The FDA granted accelerated approval to Jemperli for this indication in August 2021. The development of this CDx IVD kit is part of GSK’s post marketing commitment to the FDA to make a companion diagnostic available to support the safe and effective use of Jemperli in patients with MSI-H solid tumors.