The event will feature a presentation by Key Opinion Leaders (KOLs) David Gandara, MD (UC Davis Comprehensive Cancer Center) and Mamta Parikh, MD, MS (UC Davis Comprehensive Cancer Center), who will present an overview of the use and limitations of currently clinically available biomarkers, such as PD-L1 and tumor mutational burden (TMB), in identifying responders to immunotherapies, specifically immune checkpoint inhibitors (ICI) that are FDA-approved for a broad range of solid tumors.
New data will also be discussed, presented for the first time during an oral symposium at the 2021 American Association for Cancer Research (AACR) Annual Meeting, showing that DetermaIO™, a 27-gene test that assesses the tumor microenvironment to identify immunotherapy responders, has strong performance in identifying responders to atezolizumab in bladder cancer, as measured by overall survival rates in DetermaIO-positive patients who received ICI. This adds to previously presented data in non-small cell lung cancer and triple-negative breast cancer that demonstrates incremental utility beyond PD-L1 and TMB in identifying responders to all currently approved ICIs.
Evidence now presented for three different cancers suggests a potential pan-cancer application for the test.
Drs. Parikh and Gandara will be available to answer questions following the formal presentations.
Oncocyte is a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer. The Company, through its proprietary tests and pharmaceutical services business, aims to help save lives by accelerating the diagnosis of cancer and advancing cancer care. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients at every stage. DetermaRx™ identifies early-stage lung cancer patients who are at high risk for cancer recurrence and who may benefit from adjuvant chemotherapy. DetermaIO™, a gene expression test currently used as a research-use only tool, assesses the tumor microenvironment to predict response to immunotherapies. The Company’s pipeline of tests in development also includes DetermaTx™, which will assess the mutational status of a tumor; blood-based monitoring test DetermaCNI™, and long-term recurrence monitoring test DetermaMx™. In addition, Oncocyte’s pharmaceutical services provide companies that are developing new cancer treatments a full suite of molecular testing services to support the drug development process. DetermaRx™, DetermaIO™, DetermaTx™, DetermaCNI™ and DetermaMx™ are trademarks of Oncocyte Corporation. Keytruda®, Opdivo®, Tecentriq® and Imfinzi®, are registered trademarks of Merck, Bristol Myers Squibb, Roche Genentech and AstraZeneca, respectively.
Oncocyte Forward-Looking Statements
Oncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to DetermaIO, including its potential to serve as a predictive biomarker, and companion diagnostic, for immune therapy response prediction; its capacity to work as a companion diagnostic across the checkpoint inhibitor class of therapies and both benefit drug development and add precision to patient treatment decisions; its potential pan-cancer and pan-immunotherapy utility in both primary and metastatic settings; its expected clinical launch in Q4 2021; its potentially unique and pivotal role versus other tests in selecting patients for immunotherapy; its potential to find the right treatment for the right patient with specificity for response; and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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