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Merck, Promega Collaborate to Develop MSI CDx for Keytruda

NEW YORK – Promega announced on Wednesday that it has signed a global collaboration deal with Merck to develop an on-label, solid tumor companion diagnostic for Merck's anti-PD1 immunotherapy pembrolizumab (Keytruda) using Promega's microsatellite instability (MSI) technology.

Promega's MSI Analysis System is a fluorescent multiplex PCR-based method for the detection of microsatellite instability. It includes seven multiplexed markers for analysis of the MSI-high phenotype — five nearly monomorphic mononucleotide repeat markers and two highly polymorphic pentanucleotide repeat markers, which are used for quality control and sample authentication of matched normal and tumor tissues.

The companies are planning to seek regulatory approval for the Promega MSI CDx in the US and China and may seek approvals in other countries in the future, Promega said. Financial terms of the collaboration deal were not disclosed.

"It is gratifying to see our MSI technology have such meaning within the oncology community," Promega President and CEO Bill Linton said in a statement. "Promega developed this technology well over a decade ago, and our long-term commitment to R&D helped evolve its use."

In addition to the collaboration with Merck, Promega said it intends to seek regulatory clearance for an MSI in vitro diagnostic test in the US, China, and Europe. The company intends to launch these products in the first half of 2020.

In February, Promega announced that Japan's Ministry of Health, Labour, and Welfare had approved the MSI CDx for pembrolizumab. The CDx is distributed in Japan by Kyoto-based Falco Biosystems.