Company completes CLIA Validation of DetermaIOâ„¢, previously the Insight Genetics IM Score Test,
establishing the test as a reliable and robust assay for identifying patients likely to respond to
checkpoint inhibitor therapy
Data presented at the SITC conference in 2019 suggested that DetermaIOâ„¢ outperforms PD-L1 testing
and Tumor Mutational Burden (TMB) in predicting both responders and non-responders to checkpoint
inhibitors
Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that it had completed CLIA Validation for DetermaIOâ„¢, previously the Insight Genetics IM Score Test. The company has also officially launched DetermaIOâ„¢, making it available for research use within the biopharmaceutical and academic communities. With its ability to predict responders and non-responders to checkpoint inhibitor therapy, DetermaIOâ„¢ has the potential to be used to stratify patients in the over 3,000 PD-1/PD-L1 ongoing clinical trials that are collectively expected to recruit over 500,000 patients, representing a large pharma services opportunity.
DetermaIOâ„¢, a key component of the Insight Genetics acquisition, is a gene expression profile test that evaluates the immune microenvironment in biopsies from cancer patients to identify individuals more or less likely to respond to anti-PD-1/PD-L1 immunotherapy. The DetermaIOâ„¢ test differentiates itself from the current leading immunotherapy diagnostic tests by having the capability to determine if the immune microenvironment is active ("hot") or quiescent ("cold"). Data presented at SITC (Society for Immunotherapy of Cancer) in 2019, suggested DetermaIOâ„¢ may be superior to two currently marketed predictive companion diagnostic tests for immunotherapy selection, PD-L1 IHC staining (22c3, Dako) and tumor mutational burden (TMB). DetermaIOâ„¢ is performed in Oncocyte"™s lab in Nashville TN, an ISO:9001, CLIA and College of American Pathologists (CAP)- accredited lab which incorporates 21 CFR 820 practices by adherence to design control protocols. This quality system ensures test results exceed pharmaceutical industry standards for clinical laboratory testing. The lab has been qualified by multiple top-20 diagnostic and pharmaceutical firms for clinical sample testing.
"Identifying which patients will benefit most from immunotherapy remains an outstanding question for oncologists and pharmaceutical researchers," said Gregory Vidal, M.D., Ph.D., the principal investigator of the study presented at SITC and Assistant Professor of Hematology/Oncology at the University of Tennessee Health Science Center. "The data presented at SITC was incredibly promising, and the community is looking forward to seeing the impact the test can have on a broader patient population. I believe it has the potential to streamline the development of new therapies and improve patient outcomes."
Ron Andrews, Chief Executive Officer of Oncocyte added, "We are thrilled to have reached such an impactful set of milestones for DetermaIOâ„¢ so quickly, which is indicative of the incredible team we inherited upon completion of our acquisition of Insight Genetics in January. The commercial availability of our IO test for pharma and academic research further establishes Oncocyte as a leader when it comes to both diagnosis and treatment planning for lung cancer. The promising solid performance characteristics of DetermaIO will allow us to simultaneously pursue a CE Mark Kit strategy in Europe where we can access the installed base of the leading PCR platform manufacturers. This type of test democratization is essential for pharma to ensure patients around the world have access to the testing that will qualify them for the most appropriate course of a particular therapy. I continue to be enthusiastic about our organizational velocity as we advance multiple product efforts simultaneously."
Doug Ross, MD, Ph.D., Chief Medical Officer of Oncocyte, concluded, "With the completion of our successful CLIA validation, pharma partners interested in using DetermaIOâ„¢ for clinical studies can be confident in the results obtained and the quality of the CLIA and CAP-accredited laboratory in which the test is being performed. These CLIA Validation data demonstrate DetermaIOâ„¢ to be highly reproducible with minimal tissue input requirements and resistance to inhibitors common in FFPE tissue. We intend to present additional details at upcoming medical meetings in the summer and fall and anticipate engaging with new partners in the biopharma and research communities. With our East Coast CLIA laboratory officially up and running in Nashville, we look forward to joining forces with pharma companies and academic research centers to better understand patient response to immunotherapy."
Veronica Eames
Assistant Account Executive
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