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MolecularMD to Offer Promega Microsatellite Instability Technology

NEW YORK (GenomeWeb) – MolecularMD announced today that it will now provide Promega's Microsatellite Instability (MSI) v1.2 Analysis System as part of a larger portfolio of diagnostic and clinical research products aimed at supporting the development of oncology drugs and clinical trials.

Promega's MSI Analysis System has been commercially available since 2004 as a laboratory-developed test to aid in the diagnosis of Lynch syndrome and the classification of colorectal tumors, MolecularMD said. The firm added it will implement the MSI technology in clinical trials for pharmaceutical partners looking to develop immuno-oncology compounds into possible medications.

MolecularMD also said it has undertaken a research study utilizing an assay designed by Promega to evaluate a new set of MSI loci. In early studies, this new panel has shown increased sensitivity in colon polyps as well as tumor types outside of colorectal cancer.

"MolecularMD continues to build out a meaningful immuno-oncology test portfolio that closely aligns with our client's needs," MolecularMD President and CEO Dan Snyder said in a statement. "We are excited to work with Promega and bring together their expertise in MSI technology with our experience in delivering diagnostic assay solutions that support oncology drug development and approval."

In July, Promega said it intended to seek US Food and Drug Administration approval and CE-IVD marking for its microsatellite instability assay to help oncologists and pathologists make treatment decisions for colorectal cancer patients. In May, the FDA granted accelerated approval to Merck's PD-1/PD-L1 inhibitor Keytruda (pembrolizumab) for patients with unresectable or metastatic solid tumors with MSI-H or mismatch repair deficiency (dMMR). The approval didn't involve a complementary or companion diagnostic, however, so physicians will need to test cancer patients to define MSI-H or dMMR status. Promega said that it is also expanding its network of clinical researchers to better understand these new applications for MSI status in solid tumor types beyond colorectal cancer.