MSD has announced a new deal with Promega – a company providing solutions and technical support to the life sciences industry – to develop the company’s microsatellite instability (MSI) technology as an on-label, solid tumour companion diagnostic (CDx) for use with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab).
Recently, GlobalData predicted that the immuno-oncology blockbuster will be the best-selling drug by annual revenue in 2023, raking in $22.2 billion by 2025 and overtaking AbbVie and Eisai Co’s anti-inflammatory drug Humira (adalimumab), which is currently the world’s top-selling drug.
Unlike other DNA-based molecular screening options, Promega MSI technology uses “five monomorphic mononucleotides, which is recommended by the National Cancer Institute,” said Jeff Bacher, senior research scientist, Promega Corporation.
The technology has already been validated in labs around the world to characterise solid tumour MSI status. It works by functionally measuring the genomic accumulation of insertion or deletion (INDEL) errors caused by a deficient mismatch-repair system (dMMR) that occurs in certain types of solid tumours.
Jeff continued to say that the test uses a “sensitive and specific panel of markers for detection of MSI status and offers valuable insight to help inform physicians on how best to treat patients with cancer including those likely to benefit from immune checkpoint inhibitor treatment.”
In addition to the MSD collaboration, Promega has announced that it intends to seek regulatory clearance for an MSI in vitro diagnostic (IVD) test in the United States, China and Europe, with the products intended to launch in the first half of 2020.