Following Pivotal FDA Approval for Keytruda, Promega to Seek Clearance for Mismatch Repair Deficiency Assay

NEW YORK (GenomeWeb) – Less than two months after Merck received fast-track approval for the biomarker-guided use of its Keytruda cancer drug, Promega said it plans to seek US Food and Drug Administration clearance for an assay based on microsatellite instability technology for the detection of colorectal cancer.

The FDA’s accelerated approval for the treatment of patients whose cancers have a specific biomarker — called microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR) — marked the first time it approved a drug to be given based on the genomic features in cancer patients’ tumors, instead of where the tumor occurs in their bodies.

While the new FDA drug indication didn’t come with an FDA-approved companion test, it places a spotlight on the need for well-validated diagnostics.

Last week, Promega said that it would seek FDA clearance for its own MIS assay to help oncologists and pathologists make treatment decisions for colorectal cancer patients. The assay has been in use since 2004 as a laboratory-developed test run in CAP- and CLIA-approved labs.

“The recent announcement from the FDA on the approval of a cancer drug based on microsatellite instability status rather than the site of origin of the tumor is really

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