Oncocyte Announces the Publication of New Long-Term Patient Follow Up Data for DetermaRx™ and Research Describing the IRENE Cohort Being Used in the Development of DetermaDx™


Abstracts selected for oral presentation at the American Thoracic Society 2020 International Conference and published in American Journal of Respiratory and Clinical Care Medicine

New data on the DetermaRx™ treatment stratification test for non-small cell lung cancer demonstrates potential clinical utility and benefit to patients and payers through reduced post-surgery follow up of lung cancer patients

IRVINE, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- 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 the publication of two abstracts in the American Journal of Respiratory and Clinical Care Medicine, one detailing new data on DetermaRx™, and the other highlighting the IRENE clinical study being used for the development of DetermaDx™. Both abstracts were accepted as oral presentations at the American Thoracic Society (ATS) 2020 International Conference, which has been cancelled due to the ongoing COVID-19 pandemic.

The first abstract, entitled “Everybody Must Get Scanned? Molecular Risk Stratification May Limit the Need for CT Surveillance Following Surgical Resection of Early-Stage Non-Squamous, Non-Small Cell Lung Cancer,” was accepted as part of a mini symposium session, “Advancing Risk Assessment for Pulmonary Nodules” and highlights long term follow-up data from a 195-patient study of DetermaRx. One in three patients identified as high risk through testing with DetermaRx experienced a recurrence of their cancer, and 70% of these patients experienced a recurrence within two years of surgery. Further, 96% of patients identified as low risk through DetermaRx testing did not recur but continued to undergo frequent scans, which are associated with patient stress and can be an inefficient use of healthcare resources. The data also showed that limiting the follow up of those low risk patients to annual surveillance scans would have reduced overall scan frequency by 50%, while having little impact on detection of cancer recurrence.

“Not only do these data reinforce the clinical utility of DetermaRx in the identification of high risk cancers, which if untreated often recur relatively quickly, but they also demonstrate that it may be possible to safely reduce the use of healthcare resources by limiting radiologic follow up to annual surveillance for low-risk patients,” said Padma Sundar, Senior Vice President, Marketing and Market Access at Oncocyte. “With the COVID pandemic likely to continue to put pressure on our healthcare system for the foreseeable future, we’re more motivated than ever before to find avenues by which to conserve resources while continuing to give patients exceptional care.”

The second abstract, entitled “Diagnostic Evaluation of Pulmonary Nodules in the Irene (Immune Response for Nodule Evaluation) Cohort: A Comparison of Practice Settings,” included in the Abstract Poster Discussion Session, “Novel Insights in Lung Cancer Diagnosis, Staging, and Prognosis,” discusses practice patterns from the IRENE Biobank, which includes 2,903 patient samples from 62 sites across the United states, with comprehensive clinical data and patient follow up. The data highlight the unprecedented scale of the biobank, which can be used for development of blood-based diagnostics to aid in the management of radiologically-identified lung nodules. Significant differences in the management of pulmonary nodules between settings were identified, including differences in the rate of invasive procedures resulting in a benign diagnosis across the academic, community and Veterans Affairs settings. These findings bring attention to the clinical decision challenge that DetermaDx, which is designed to help more judiciously manage the use of invasive biopsy procedures for diagnosis of lung nodules, has the potential to address.

About Oncocyte Corporation

Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. DetermaDx™, the company’s liquid biopsy test in development, utilizes a proprietary immune system interrogation approach to clarify if a patients’ lung nodules are benign, which may enable them to avoid potentially risky invasive diagnostic procedures. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.

DetermaDx, DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.

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 the commercial launch of DetermaRx, development of DetermaDx and DetermaIO, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte, along with 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 our financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize, and risks inherent in acquisitions such as failure to realize anticipated benefits, unexpected expenditures or assumed liabilities, unanticipated difficulties in conforming business practices including accounting policies, procedures and internal controls, greater than estimated allocations of resources to develop and commercialize technologies, or 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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Bob Yedid
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com

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