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FALCO biosystems and Promega Corporation MSI-IVD Kit Collaboration Obtains Approved Companion Diagnostic Status in Japan

Promega Corporation today announced FALCO biosystems of Kyoto, Japan, a core business company of FALCO HOLDINGS, working in collaboration with Promega microsatellite instability (MSI) chemistry and assay design, obtained companion diagnostic approval for FALCO’s MSI-IVD from Japan’s regulatory agency, the Ministry of Health, Labour and Welfare (MHLW).

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A MSI-IVD Kit by FALCO biosystems, in collaboration with Promega Corporation microsatellite instability (MSI) chemistry and assay design, has obtained companion diagnostic approval in Japan. The Kit is the first pan-tumor companion diagnostic test in Japan and is intended to identify patients suitable for treatment with the anti-PD-1 antibody “KEYTRUDA®” (Pembrolizumab). (Photo: Business Wire)

The MSI-IVD Kit (FALCO), which detects MSI-High within tumor tissues as a biomarker of DNA repair dysfunction, is the first pan-tumor companion diagnostic test in Japan. Its intended use is to identify patients suitable for treatment with the anti-PD-1 antibody “KEYTRUDA®” (Pembrolizumab).

The FALCO kit detects MSI-High status with DNA isolated only from a patient’s tumor tissue, without corresponding submission of a blood sample, using multiplex PCR fragment analysis with Promega designed five mononucleotide repeat markers, which are less susceptible to genetic polymorphisms. The clinical performance study conducted for the kit confirmed the detection capability of MSI-High in 16 different cancer types for stomach, uterine, breast, pancreas, etc. other than colorectal cancer.

Promega MSI technology uses the same loci that have been validated in labs around the world and is the gold standard in nucleic acid based MSI testing. A 2018 College of American Pathologists survey indicated that 70% of respondents performing nucleic acid based MSI testing were doing so using the Promega MSI 1.2 panel of loci.

Promega Corporation’s latest MSI technology was recently granted innovation designation by the Chinese National Medical Products Administration (NMPA) and the company intends to seek US Food and Drug Administration (FDA) approval for IVD status of its MSI 1.2 platform.

About Promega

Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s 4,000 products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, drug discovery and human identification. Founded in 1978, the company is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. For more information about Promega, visit

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Last Updated: 05-Feb-2019