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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 Tomlinson, business unit leader for molecular diagnostics at Promega, said in a statement.

"Our research showed that large marker panels and tumor mutation burden as defined by next-generation sequencing are excellent tools for research, but the impact of the information they provide is unclear, the assays are too costly, and the turnaround time is too long to be used routinely in a diagnostic setting in the near term," Tomlinson added. "We will do everything we can to accelerate the delivery of the MSI technology for these labs in compliance with appropriate regulatory agencies."

Madison, Wisconsin-based Promega said that it will rely on its experience and expertise in designing fragment analysis and multiplex PCR assays for the forensic industry to develop additional assays to expand and improve upon its current MSI product offering over the next several years. One example, it noted, is a more sensitive MSI kit currently under development as an IVD at Promega Shanghai for potential Chinese Food and Drug Administration approval.