November 13, 2017

MolecularMD to Implement Promega’s Microsatellite Instability (MSI) Technology for Immuno-Oncology Applications

PORTLAND, OR and CAMBRIDGE, MA— November 13, 2017 — MolecularMD announces that it has now become a Preferred Provider of Promega’s Microsatellite Instability (MSI) v1.2 Analysis System.  MolecularMD has completed validation of the MSI Analysis System for the analysis of multiple tumor types and is now offering the technology as part of a broader portfolio of diagnostic and clinical research solutions for the support of oncology drug development and clinical trials.

Promega’s MSI Analysis System, Version 1.2 has been commercially available and widely used since 2004 as a Laboratory Developed Test to aid in the diagnosis of Lynch Syndrome and the classification of colorectal tumors.  This patent-protected technology is considered to be the gold standard molecular assay for detecting DNA mismatch-repair deficiency.  The MSI biomarker is proving to be increasingly important in the selection of patients for treatment with checkpoint inhibitors and other compounds.  MSI detection has been the technology of choice for researchers looking at DNA mismatch repair as well as DNA damage, due to its reliability, simplicity and throughput.

MolecularMD expects to implement Promega’s MSI technology in clinical trials for pharmaceutical partners pursuing immuno-oncology compounds.  In addition to implementing the v1.2 assay, MolecularMD has also initiated a research study utilizing an assay designed by Promega that evaluates a new set of MSI loci. In early studies, this new panel has shown increased sensitivity in colon polyps as well as tumor types outside of colorectal cancer.

“MolecularMD continues to build out a meaningful immuno-oncology test portfolio that closely aligns with our client’s needs,” said Dan Snyder, MolecularMD’s President and CEO. “We are excited to work with Promega and bring together their expertise in MSI technology with our experience in delivering diagnostic assay solutions that support oncology drug development and approval.”

“It is gratifying to see the utility of the MSI data expanding into precision medicine,” noted Heather Tomlinson, Head of the Promega Clinical Diagnostic Business Unit. “The technology has the potential in the future to truly make a difference in the lives and survival of cancer patients,” she continued.  Promega announced plans to obtain FDA approval for the MSI system for use in guiding colorectal cancer treatment decisions.