BUFFALO, NEW YORK – April 16, 2018 – OmniSeq®, a molecular diagnostics subsidiary of the Roswell Park Comprehensive Cancer Center, and LabCorp® (NYSE: LH), a leading global life sciences company, announced today the commercial launch of OmniSeq MSI NGS, a tumor-only, next generation sequencing (NGS) Microsatellite Instability (MSI) assay.
OmniSeq MSI NGS is approved by the New York State Clinical Laboratory Evaluation Program (CLEP) and OmniSeq is accepting clinical samples from U.S.-based physicians exclusively through Integrated Oncology, a member of the LabCorp Specialty Testing Group, and globally to biopharmaceutical customers through Covance Drug Development. The assay will be offered at the lowest cost and with the lowest sample requirement in the industry, using only 10ng of DNA input.
According to the FDA, Microsatellite Instability High (MSI-H) tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with this biomarker are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland and other places. Approximately 5 percent of patients with metastatic colorectal cancer have MSI-H tumors.
In May, 2017, the FDA granted accelerated approval to Keytruda (pembrolizumab) as indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.
“The OmniSeq MSI NGS assay addresses one of the most significant pain points in the laboratory workflow for considering patients for immunotherapy,” said Dr. Carl Morrison, President, Founder and Chief Medical Officer of OmniSeq. “Avoiding the need to collect a normal sample with this NGS-based method addresses a significant market need following the FDA accelerated approval last year of MSI-H for pan-cancer, solid tumor histologies.”
“LabCorp continues to take a first-to- market position among cancer immunotherapy diagnostics and the launch of OmniSeq MSI NGS through Integrated Oncology is another demonstration of our ability to launch timely assays through innovative partnerships,” said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. “The Integrated Oncology unit will continue to offer the matched tumor-normal PCR MSI test for interested providers across the U.S.”
In August, 2017, OmniSeq and Integrated Oncology, a member of the LabCorp Specialty Testing Group, announced an exclusive distribution agreement for the OmniSeq Comprehensive® and Immune Report Card® clinical assays. OmniSeq Comprehensive® is a 144 gene, pan-cancer, next-generation sequencing (NGS) tumor profiling diagnostic panel to guide oncology treatment decision-making. Immune Report Card® is a first-in- kind comprehensive immune profiling test designed to inform oncologists regarding checkpoint inhibitor (CPI) treatment decisions. OmniSeq Comprehensive® and Immune Report Card® are also both approved by the New York State Clinical Laboratory Evaluation Program (CLEP).