Promega to Seek FDA Approval, CE-IVD Mark for Microsatellite Instability Assay

NEW YORK (GenomeWeb) – Promega said today that it intends 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.

Promega currently offers the MSI assay for research use only. The test uses fluorescent multiplex PCR to co-amplify seven markers for analysis of the MSI-high (MSI-H) phenotype, including five nearly monomorphic mononucleotide repeat markers and two highly polymorphic pentanucleotide repeat markers.

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.

“Following recent specific discussions with a number of labs, it is clear that they view the Promega MSI assay as an important tool for determining DNA mismatch repair deficiency that is a more straightforward measurement relative to next-generation sequencing,” Heather Baird

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