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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.

The Scan

Close Panel Vote on Califf Nomination

The New York Times reports there was a close committee vote to advance the nomination of Robert Califf to lead the US Food and Drug Administration to the full Senate.

Task Force Reports on Scientific Integrity

Nature News writes that that a new task force report recommends that the US establish a cross-agency scientific integrity council.

Across the Hall

Genetic testing, closed-circuit cameras, and more show how a traveler, without any contact, infected others at a New Zealand quarantine facility, CNN reports.

Science Paper Examines Influence of Chromatin Modifications on Obsessive-Compulsive Disorder

In Science this week: genes regulating chromatin modification may contribute to OCD risk.