Market Overview

Promega Microsatellite Instability Technology Receives Innovation Designation from Chinese National Medical Products Administration


Promega Corporation's latest microsatellite instability (MSI) technology
has been granted innovation designation by the Chinese National Medical
Products Administration (NMPA). Promega MSI technology has been
validated in labs around the world. With innovation status, the path to
become classified as an invitro diagnostic (IVD) will gain elevated
efficiency by having a program coordinator assigned from NMPA and
priority status for multiple processes.

"We are excited and honored with this decision from NMPA," says Frank
Fan, Senior Director of Research & China Operations at Promega. "Our
Promega China team appreciated the emerging and important role our MSI
technology can play in health care because of its sensitivity and
prominent use around the world. Innovation Designation accelerates our
hope to get the best tools in the hands of clinicians and bring benefits
to patients."

This version of the Promega MSI platform, trademarked ProDx® in China,
is the latest version (MSI 2.0) of the Promega MSI technology. This
technology is a PCR-based method for detecting MSI, a form of genomic
instability caused by the insertion or deletion of repeating bases
called microsatellites during DNA replication and the failure of the
mismatch repair system to correct these errors. MSI status is a measure
of mismatch-repair deficiency commonly found in solid tumors, providing
oncologists, pathologists and patients more information to determine the
best treatment path. This new MSI technology is currently being accessed
globally in investigator-initiated trials to determine its application
in solid tumors beyond colon cancer.

Promega continues to advance the promise of MSI technology globally. In
the US, Promega intends to seek Food and Drug Administration (FDA)
approval for IVD status of the MSI 1.2 platform. 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.

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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