Data shows broad adoption and real-world clinical utility of its DetermaRx™ test for early-stage lung cancer

IRVINE, Calif., Jan. 28, 2021 (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 that it will present a scientific poster highlighting the broad adoption and real-world clinical utility of its DetermaRx™ test for early-stage lung cancer at the IASLC 2020 World Conference on Lung Cancer (#WCLC20), hosted by the International Association for the Study of Lung Cancer, taking place virtually on January 28-31, 2021. DetermaRx is Oncocyte’s treatment stratification test to identify patients with Stage I and IIA non-squamous NSCLC who may benefit from adjuvant chemotherapy. The commercially available test is Medicare-reimbursed, and has been extensively validated to stratify risk and predict treatment benefit in early-stage non-squamous NSCLC.

These data, which will be presented by Dr. Doug Harrington, Medical Director, and Sara Riordan, Genetic Counselor and Senior Director of Medical Education for Oncocyte, are based on an analysis of 250 cases for which treating physicians across 39 academic and community hospitals ordered the DetermaRx test for clinical use. These new findings reinforce previously published data showing the DetermaRx test outperforms standard clinical factors that are used to identify and treat patients at high risk of recurrence following surgery. Previously published studies have shown that these patients have a significant improvement in survival when treated with adjuvant chemotherapy—92% compared with 49%. DetermaRx is being ordered by thoracic surgeons as well as oncologists, for testing all stages of cancer for which it is CMS approved, including Stage I and Stage IIA patients, indicating that physicians see broad utility in the test.

Other highlights of the new data:

• 19% of patients having none of the high-risk clinical features in NCCN guidelines were re-classified as high/intermediate risk by DetermaRx.
• One out of four of earliest stage lung cancer patients (Stage IA) were classified as intermediate- or high-risk by the DetermaRx test. These patients were previously not believed to be candidates for adjuvant chemotherapy treatment although data suggests about 30% will experience a recurrence. This represents a new group of patients for whom biomarker testing is being ordered, given clinical utility.
• Multi-center real-world data reinforces a single-center study demonstrating that the test reclassifies NCCN clinical feature-based risk, underscoring the potential clinical utility of DetermaRx in a broad U.S. population.
  

Padma Sundar, Chief Commercial Officer at Oncocyte said, “We are very pleased with the broad adoption and demonstrated real world utility of DetermaRx in its first year of launch across leading community and academic centers, which we believe is a strong indication of the real world utility of the test. Through our ongoing sales and educational activities, we are actively adding more sites and physicians, and now have a total of 80 hospitals onboarded to use DetermaRx. With these ongoing development and commercial activities, combined with new additions to our sales force, we expect continued growth of our customer base. Taken together, we are optimistic about the continued adoption of DetermaRx and see this as an important foundation for our planned expansion of additional diagnostic offerings that we hope to offer to this growing network of hospitals and physicians.”

Details on Oncocyte’s poster presentation:

Title

: “Characterization of Clinicopathologic Features and Molecular Recurrence Risk Profiles in Patients with Early-Stage NSCLC”


Abstract # 3708


Authors: Sara Riordan, Martina Doleshal, Jason Orck, Douglas Harrington

The poster will be on display beginning January 27, 2021 until the virtual poster hall closes on April 30, 2021. The poster will also be made available on the Oncocyte website:

https://oncocyte.com/publications-and-abstracts/

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. The Company, through its proprietary tests and pharmaceutical services business, aims to help save lives and improve outcomes by accelerating and optimizing the diagnosis and treatment of cancer. The Company’s tests and services present multiple opportunities to advance cancer care while also driving revenue growth for the Company. Oncocyte recently launched DetermaRx™, a test that identifies early-stage lung cancer patients who are at high risk for cancer recurrence post-resection and predicts benefit from adjuvant chemotherapy. Oncocyte has also launched DetermaIO™, a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, as a research use only tool for pharmaceutical and academic clinical trials. To complement DetermaIO, the company anticipates launching DetermaTx™, a test to assess mutational status of a tumor to help identify the appropriate targeted therapy, in the second half of 2021. The Company also continues with the development of DetermaMx™ as the company seeks to expand into the blood-based monitoring market. Oncocyte’s pharmaceutical services provide pharmaceutical companies who are developing new cancer treatments a full suite of molecular testing services to support the drug development process.

DetermaRx, DetermaIO, DetermaMx and DetermaTx 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 continued adoption and clinical utility of DetermaRx, unexpected delays, unexpected expenditures, indemnities or other liabilities, or other unanticipated difficulties resulting from technology transfers, commercial plans, invalidation, termination or reduction of any licensed intellectual property rights, or infringement of third party intellectual property rights, acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans, future financial and/or operating results, and future opportunities for Oncocyte or any distributor, 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 or any distributor’s 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 or any distributor’s supply chain, 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 we commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality 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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