Skip to main content
Premium Trial:

Request an Annual Quote

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

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.

Genome-Wide Analysis Sheds Light on Genetics of ADHD

A genome-wide association study meta-analysis of attention-deficit hyperactivity disorder appearing in Nature Genetics links 76 genes to risk of having the disorder.

MicroRNA Cotargeting Linked to Lupus

A mouse-based study appearing in BMC Biology implicates two microRNAs with overlapping target sites in lupus.

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.