Oncocyte announces collaboration with Gruppo Oncologico del Nord Ovest to evaluate Oncocyte’s DetermaIO test in colorectal cancer, the second leading cause of cancer death worldwide

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Gruppo Oncologico del Nord Ovest, a leading European clinical research group, conducts independent investigator-sponsored clinical trials for pharmaceutically-targeted and immunotherapies

If successful, Oncocyte’s DetermaIO assay for immunotherapy response prediction will be validated in a fifth tumor type, enhancing the potential for pan-cancer utility

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IRVINE, Calif., June 3, 2021 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a molecular diagnostics company with a mission to provide actionable answers to critical decision points in the cancer care continuum, today announced a strategic partnership with Gruppo Oncologico del Nord-Ovest (GONO Foundation)) of Pisa, Italy, to evaluate DetermaIO™, Oncocyte’s proprietary gene expression assay that assesses the tumor immune microenvironment from a biopsy sample, as a biomarker of immunotherapy response in metastatic colorectal cancer (mCRC). This is the fifth tumor type to be evaluated for DetermaIO, which has previously demonstrated the ability to predict response to immunotherapy in four different cancer types: lung, breast, bladder and kidney cancers.

GONO Foundation conducts research in oncology, designs clinical trials that improve the treatment of patients with solid tumors, and is currently conducting several investigator-sponsored randomized trials in colorectal cancer, comparing different therapies to the current standard of care, including the usefulness of an immune checkpoint inhibitor, a class of immunotherapies. These randomized clinical trials are accompanied by biomarker studies designed to distinguish patients who respond to immunotherapy from patients who do not respond, making GONO the ideal collaboration partner for Oncocyte.

Chiara Cremolini, MD, Ph.D, Chair of the GONO Foundation and Assistant Professor in the Department of Translational Research, University Hospital of Pisa, said: “With the growing body of promising data presented on DetermaIO to improve the immune therapy response for several other cancers Indications to be determined, we welcome our collaboration with Oncocyte in our clinical studies Determining which patients with metastatic colorectal cancer who do not have microsatellite instability and who are currently excluded from immunotherapy but who could benefit from this treatment option will be a very important milestone in the treatment of this devastating disease, and we look forward to presenting the data from this study at a future scientific meeting.”

“We are honored to have been selected to partner with the GONO Foundation in their clinical trial and biomarker strategy with this important opportunity to test the clinical performance of DetermaIO in metastatic colorectal cancer, one of the leading causes of cancer deaths across the globe. around the world,” said Doug Ross, MD, Ph.D., Oncocyte’s chief science officer. “DetermaIO has been able to effectively predict the response of immunotherapy in the four tumor types studied to date and we are excited to expand the reach of DetermaIO to a fifth indication. We look forward to working with Dr. Cremolini to define the role of DetermaIO in colorectal cancer, which may ultimately provide further support for a pan-cancer applicability of DetermaIO in predicting response to immune checkpoint inhibitor therapy.”

Heinz-Josef Lenz, MD, FACP, Associate Director for Clinical Research and Co-Leader of the Translational Science Program at USC Norris Comprehensive Cancer Center, and member of the Oncocyte Medical Advisory Board, said, “I believe DetermaIO is an important and clinically useful biomarker in identifying responders to immunotherapy, and the clinical evidence generated to date is very exciting.DetermaIO takes a comprehensive biological approach by assessing the tumor microenvironment, enabling it to incrementally useful in addition to the markers we currently use for the selection of immunotherapy treatments.As a doctor treating colon cancer, it would be valuable for me to be able to provide more patients with immunotherapy.GONO Foundation and Dr. Cremolini are highly respected in the world of immuno-oncology and the collaboration with Oncocyte is topical and important.If DetermaIO successfully supplements patients n that would respond to IO therapy but are not indicated by the MSI marker, this would represent another important step in supporting the clinical utility of pan cancer.”

Colon cancer is the third most common cancer in the world, with an estimated 1.9 million cases worldwide and 935,000 deaths in 2020, ranked third in terms of occurrence and second in terms of mortality of all forms, according to the American Cancer Society. of cancer. In the US alone, there were an estimated 147,950 cases and 53,200 deaths in 2020. Although immunotherapies have been approved for this tumor type in patients who are positive for the microsatellite instability biomarker (MSI), only 5% to 10% of metastatic colorectal patients have been shown to be positive for this biomarker, meaning that there may be other patients who are beneficial. would respond to immunotherapy but are missed by the MSI biomarker.

About Oncocyte CorporationOncocyte is a molecular diagnostics company whose mission is to provide actionable answers to critical decision points in the cancer care continuum. The company, through its own testing and pharmaceutical services, aims to help save lives and improve outcomes by accelerating and optimizing cancer diagnosis and treatment. The company’s testing and services provide multiple opportunities to advance cancer care while driving revenue growth for the company. Oncocyte launched DetermaRx™, a test that identifies early-stage lung cancer patients at high risk of cancer recurrence after resection, and predicts the benefit of adjuvant chemotherapy. Oncocyte has also launched DetermaIO™, a gene expression assay that assesses the tumor microenvironment to predict response to immunotherapies, as a research-only tool for pharmaceutical and academic clinical trials. Complementing DetermaIO™, the company expects to launch DetermaTx™ in the second half of 2021 as a test to assess the mutational status of a tumor to help identify the appropriate targeted therapy. The company recently completed its acquisition of Chronix Biomedical Inc. and its TheraSure™ CNI Monitor (rebranded as DetermaCNI) and TheraSure™ Transplant Monitor test, both of which are available for clinical research in the EU, and also plans to continue development of DetermaMx™ as the company seeks to expand to the blood monitoring market. Oncocyte’s pharmaceutical services offer a full range of molecular testing services to support the drug development process for pharmaceutical companies developing new cancer treatments.

DetermaRx, DetermaIO, DetermaMx and DetermaTx are trademarks of Oncocyte Corporation and TheraSure™ is a trademark of Chronix Biomedical, Inc.

About Gruppo Oncologico del Nord-Ovest (GONO Foundation). Gruppo Oncologico Nord-Ovest (GONO) is a scientific association of doctors and researchers, with the aim of contributing to the development of clinical research and study design in the field of clinical oncology. This cooperative group was founded in 1987 with the aim of promoting independent research in Italy, ie research projects not driven by companies.

Oncocyte Forward-Looking StatementsOncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical facts (including, but not limited to, statements containing words such as “will,” “believes,” “plan,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those related to the DetermaIO gene expression test in the colorectal clinical trials, including its potential use and efficacy, potential addressable market size, and other statements about the future expectations, beliefs, goals, plans or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, but not limited to, the potential impact of COVID-19 on the financial and operating results of our or our subsidiaries, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the ability of our third-party blood sample analysis system to provide consistent and accurate analytical results on a commercial scale, potential supply chain disruptions, the need and ability to raise future capital obtaining, maintaining intellectual property rights in all applicable jurisdictions, and the need to obtain compensation from third parties for patient use of diagnostic tests that we or our subsidiaries commercialize, and risks inherent in strategic transactions ties, such as failure to realize anticipated benefits, legal, regulatory or political changes in applicable jurisdictions, accounting and quality controls, potentially exceeding the estimated allocation of resources to develop and commercialize technologies, or potential failure to achieve laboratory accreditation or maintain certification. Actual results may differ materially from those anticipated in these forward-looking statements and accordingly, such statements should be assessed in conjunction with the many uncertainties affecting Oncocyte’s business, particularly those disclosed in the “Risk Factors” and other cautionary statements in Oncocyte’s Filings of the Securities and Exchange Commission, which are available on the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Oncocyte assumes no obligation to update such statements to reflect events that occur or circumstances that exist after the date they are made, except as required by law.

Contact person for investorsBob YedidLifeSci Advisors, LLC646-597-6989bob@lifesciaadvisers.com

Media contactTerri Clevenger Westwicke/ICR203-856-4326Terri.clevenger@westwicke.com

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Source: Oncocyte Corporation

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