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OmniSeq, Inc. to Participate in the NCI-MATCH Clinical Trial
Having Met Rigorous Qualifications, OmniSeq Becomes One of Several Commercial and Academic Laboratories Designated by the National Cancer Institute to Cast a Wider Net for Patients to Enter the NCI-MATCH Trial
BUFFALO, N.Y., July 31, 2018 (GLOBE NEWSWIRE) -- OmniSeq, Inc.® a leading innovator in molecular science, today announced it is participating as a CLIA-certified/accredited laboratory for the NCI-Molecular Analysis for Therapy Choice (NCI-MATCH or EAY131) precision medicine trial, which is being co-led by the National Cancer Institute (NCI), part of the National Institutes of Health, and the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN). Under the terms of the collaboration, OmniSeq will reach out and notify treating oncologists from more than 1,100 clinical sites participating in NCI-MATCH when the OmniSeq Comprehensive® assay, its comprehensive next generation sequencing molecular assay, identifies gene abnormalities that could make a patient eligible for one of several NCI-MATCH treatments. Tumor gene testing by a designated lab is the only pathway for patients to enroll into the trial.
“NCI-MATCH is a study to learn more about associations between tumor mutations and targeted therapies, and the trial will contribute to the implementation of precision medicine for cancer patients,” said Carl Morrison, M.D., President and Chief Medical Officer, Clinical Chief, Department of Pathology and Laboratory Medicine and Professor of Oncology at Roswell Park Comprehensive Cancer Center. “We look forward to collaborating with both ECOG-ACRIN and the NCI and believe our OmniSeq Comprehensive® assay will capably identify eligible patients to help the trial meet its goals, including those treated at Roswell Park Comprehensive Cancer Center.”
When a treating oncologist at a participating NCI-MATCH site orders tumor profiling to guide clinical care for their patient, OmniSeq will look for trial matches for the patient. Upon the identification of a qualifying genetic alteration abnormality (such as a mutation, amplification or translocation), NCI and ECOG-ACRIN trial leaders will review OmniSeq’s trial match centrally. If they verify the referral, they will formally assign the patient to the treatment arm and notify OmniSeq, which will, in turn, inform the treating physician about the NCI-MATCH trial. OmniSeq will facilitate communication between treating physicians and NCI-MATCH study investigators. To read a summary of the process, visit http://ecog-acrin.org/nci-match-eay131-designated-labs.
“Tumor profiling and genomic testing are becoming common in daily practice for oncologists to help guide clinical care for cancer patients,” said NCI-MATCH study co-chair James V. Tricoli, Ph.D., Chief, Diagnostic Biomarkers and Technology Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis at the NCI. “We require qualifying laboratories to proactively identify potentially eligible patients for the NCI-MATCH trial.”
NCI-MATCH (EAY131 or NCT02465060) is a phase 2 precision medicine trial that seeks to determine the effectiveness of treatment that is directed by genomic profiling in patients with solid tumors, lymphomas, or myelomas that have progressed following standard treatments expected to prolong survival, or for rare cancer types for which there is no standard treatment. Such discoveries could be eligible to move on to larger, more definitive trials. With nearly 40 treatment arms addressing a wide range of tumor types and targeted treatments, NCI-MATCH is the largest precision medicine cancer trial to date. To learn more about NCI-MATCH, including clinical trial sites across the country, visit www.ecog-acrin.org/nci-match-eay131.
“NCI-MATCH is a discovery trial whose very nature—identifying and exploring knowledge gaps in precision oncology, and advancing new hypotheses—means studying small subsets of patients,” said ECOG-ACRIN study chair Keith T. Flaherty, MD, director of Clinical Research at the Massachusetts General Hospital Cancer Center, and professor of medicine at Harvard Medical School. “We are qualifying additional laboratories so we can cast a wider net for patients with the biomarkers of interest.”
OmniSeq will also participate with NCI and ECOG-ACRIN in a concordance evaluation that will compare the results from OmniSeq’s next-generation sequencing for the trial patients they identify to the NCI-MATCH assay. Consistent, accurate data detection and reporting of genomic alterations across various academic and commercial laboratories has important implications for patient care as the demand for genomic information continues to increase.
OmniSeq, an innovation of Roswell Park Comprehensive Cancer Center, is a molecular diagnostic laboratory based in Buffalo, New York. OmniSeq endeavors to find the right drug or the right trial for every patient by improving access to better cancer treatment options through molecular profiling. OmniSeq offers three NGS-based assays: Immune Report Card®, OmniSeq Comprehensive®, and OmniSeq AdvanceSM. OmniSeq is proud to partner with academic researchers and pharmaceutical companies to support immuno-oncology diagnostics. For more information, call 1-800-781-1259 or visit www.omniseq.com.
OmniSeq Media Relations: CorpComm@omniseq.com or 1-800-781-1259