OmniSeq, an innovation of Roswell Park Cancer Institute, announced today the commercial launch of Immune Report Card SM, the first immune profiling test designed to help oncologists select the best mono and combination immunotherapy options for their patients. The assay integrates five clinical-grade tests that together provide a Comprehensive Immune Profile to optimize likelihood of response to cancer immunotherapy treatment.
Immune Report CardSM is approved by the New York State Clinical Laboratory Evaluation Program (CLEP) and OmniSeq is accepting clinical samples from physicians considering administration of checkpoint inhibitors (CPIs) such as Keytruda, Tecentriq and Opdivo for patients with advanced stage solid tumor cancers. Immune Report Card SM combines OmniSeq’s proprietary sample preparation, using as few as 8 unstained FFPE slides, with OmniSeq’s reference database and information technologies to produce patient results within ten days of sample receipt.
Immune Report Card includes CD3/8 and PD-L1 immunohistochemistry (IHC), PD-L1/2 copy number using florescent in situ hybridization (FISH), microsatellite instability testing (MSI), mutational burden (MuB) analysis via Thermo Fisher Scientific’s Ion Torrent® next generation sequencing of 409 full exon cancer genes (DNA-seq), and cross-validated, simultaneous gene expression analysis of 54 critical transcripts via targeted RNA-seq using the Oncomine™Immune Response Research Assay (OIRRA). Each of these five tests has individual merit; synthesizing the information in a single report enables physicians to conveniently assess the most relevant information for treatment decision support.
OmniSeq anticipates its unique method of Comprehensive Immune Profiling will better support identification of the 20-40% patients that are likely to respond to CPI monotherapy, and provides a rational solution for selecting patients for combination immunotherapy clinical trials. Data highlighted at ASCO 2017 by Dr. Marc Ernstoff illustrate that only a quarter of patients treated at Roswell Park with checkpoint inhibitors were either PD-L1 IHC High (greater than 50% tumor proportion score) and/or had high mutational burden. By contrast, RNA-seq revealed that an incremental half (48%) of all treated patients highly expressed a targetable immune marker currently under evaluation in a clinical trial. Immune Report CardSM may become an important tool to rationally stratify patients and enrich for optimal immunotherapy combinations in over 800 active clinical trials.
“OmniSeq has a proven track record for successfully earning New York State CLEP approval for complex assays like Immune Report Card,” said Carl Morrison, President and Chief Scientific Officer of OmniSeq. “The Immune Report Card synthesizes the most complete diagnostic information set for a patient’s immune status. Prior to this test, clinicians might have to order from many labs and assemble for themselves what we have integrated with a single report.”
Dr. Marc Ernstoff, Professor and Katherine Anne Gioia Chair of the Department of Medicine and SVP of Clinical Investigation at Roswell Park Cancer Institute, stated, “Immunotherapy has rapidly become a new paradigm for cancer care. At Roswell Park, the use of immunotherapy drugs is growing more than 75% per year. We have a clear need for better diagnostic tools to inform treatment decisions for immunotherapy, and comprehensive immune profiling will give our clinicians and patients a much fuller picture to look at as they consider the options.”
Source – Globe Newswire