Promega first developed its microsatellite instability (MSI) Analysis System 15 years ago as a NASA-funded effort for monitoring the effects of radiation on astronauts. The “Research Use Only” technology grew to become the gold standard in nucleic acid-based MSI testing for research labs around the world. With the recent advent of the new cancer immunotherapy treatment Keytruda® (pembrolizumab) based on a common biomarker rather than where in the body a tumor originates, a new application for our MSI technology emerged.
In late 2018, Japan’s Ministry of Health, Labour and Welfare approved a companion diagnostic based on our MSI technology to identify patients suitable for treatment with Keytruda®. The test was developed in collaboration with FALCO biosystems of Kyoto, Japan. The MSI-IVD Kit (FALCO) is a DNA analysis test used to detect high microsatellite instability (MSI-H). MSI-H is a biomarker in tumor tissue indicating that certain sections of DNA, called microsatellites, have become unstable. This instability biomarker shows the major mismatch repair genes that correct errors during DNA replication are not functioning properly. Keytruda® works to boost the ability of one’s immune system to identify and fight these tumor cells, and has been approved for use in patients with the MSI-H biomarker in many countries, including the US and Japan. The MSI-IVD Kit (FALCO) is the first such pan-tumor companion diagnostic test in Japan.
Our latest MSI technology was also recently granted “innovation designation” by the Chinese National Medical Products Administration (NMPA), and we intend to seek US Food and Drug Administration (FDA) clearance for an in vitro diagnostic (IVD) version of our MSI 1.2 platform.
Providing High-Quality, Reliable Tools for Clinical and Molecular Diagnostics Laboratories
Clinical and molecular diagnostic laboratories rely on access to high-quality, consistently performing products in their assays. Promega manufactures reagents under a rigorous quality program that contributes to robust and reliably performing molecular assays. Products are manufactured to the highest quality standards through maintenance of ISO 9001 and ISO 13485 certification as well as enhanced capabilities for cGMP manufacturing. The Promega PCR Optimization Kit, launched in 2016, allows customers to rapidly define their own unique PCR master mix for a variety of applications in research or clinical use. This is just one example of how we can provide flexible solutions with product customization options to meet clinical laboratory or IVD manufacturers’ needs.