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Japanese Regulators Approve Promega CDx for Merck's Keytruda

NEW YORK (GenomeWeb) — Promega announced today that Japan's Ministry of Health, Labour, and Welfare has approved a companion diagnostic for Merck's cancer immunotherapy Keytruda (pembrolizumab) based on its microsatellite instability (MSI) technology.

The test uses multiplex PCR fragment analysis with Promega-designed five-mononucleotide repeat markers to detect the MSI-high phenotype within tumor tissues — without corresponding submission of blood samples — as a biomarker of DNA repair dysfunction. It is indicated for the identification of patients suitable for Keytruda treatment and is offered in Japan by Kyoto-based Falco Biosystems.

Earlier this year, Madison, Wisconsin-based Promega said that its MSI technology was granted innovation designation by the Chinese National Medical Products Administration. In mid-2018, it partnered with Core Diagnostics to offer its MSI testing technology in India, and in 2017 it struck a similar deal giving MolecularMD the rights to offer the technology in a larger portfolio of its diagnostic and clinical research products.

Promega said that it intends to pursue US Food and Drug Administration approval for IVD status of its MSI platform.