Oncocyte Announces Distribution Agreement with CORE Diagnostics, Expanding Commercial Availability of DetermaRx™ to India, the Middle East and Africa

IRVINE, Calif., April 23, 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 that it has entered a distribution agreement with CORE Diagnostics, expanding the commercial availability of DetermaRx™ to India, the Middle East and Africa. DetermaRx™ is Oncocyte’s treatment stratification test that identifies patients at high risk for lung cancer recurrence, who may benefit from adjuvant chemotherapy post-surgery.

CORE Diagnostics is one of the fastest-growing clinical laboratories in India, focused on bringing the most advanced testing techniques and expertise to the country. Under the terms of the agreement, tissue samples needed for the test will be run in the United States by Oncocyte, while CORE Diagnostics will generate test orders and provide customer service to patients.

“As we think about expanding beyond the U.S., one of our strategies is to partner with labs focused on delivering high value, proprietary diagnostics into an existing oncology channel to generate demand and brand awareness. CORE Diagnostics does exactly that,” said Ron Andrews, Chief Executive Officer of Oncocyte. “We believe CORE’s oncology salesforce of 100 people and customer base of 5000 ordering physicians in 12 different countries will be critical as we work to increase awareness and availability of our tests among physicians and patients globally. We are thrilled to embark on this collaboration with such a respected and growing brand in this important market and are looking forward to tens of thousands more patients having access to our tests, potentially saving lives in the process. As we continue to grow, we intend to extend this distribution model to other geographies including South America and other parts of Asia as well.”

Zoya Brar, Chief Executive Officer and Founder of CORE Diagnostics added, “The market for molecular testing in India and the Middle East is quite large. We focus on partnering with labs that offer proprietary diagnostics fulfilling an unmet need at a patient friendly price for our population, and we believe DetermaRx perfectly fits these characteristics. We look forward to making this test and potentially other diagnostic tests from Oncocyte available across these countries in the future.”

DetermaRx was launched in the United States through an Early Access Program (EAP) in late January 2020 with two sites. Since then it has continued to gain traction, rapidly expanding to eighteen sites in just the first three months of launch. These targeted sites are located across the country including multiple community cancer centers where early stage cancer is managed including physicians from large community-based systems, such as Dignity Health and Northshore Oncology. The Company has onboarded eight sites in the past month despite COVID-19 challenges throughout the country. Oncocyte will begin serving physicians in these sites once surgeries for early stage lung cancer ramp back up over the coming months.

“We’re thrilled with the progress made thus far to expand the availability of DetermaRx, both in the U.S. and beyond,” said Padma Sundar, Senior Vice President, Marketing and Market Access at Oncocyte. “I’m incredibly proud of our team’s rapid pivot to virtual operations as the COVID-19 situation began to progress and am confident that the quick expansion in DetermaRx test adoption sites was driven by this foresight. Our online peer-to-peer physician engagement initiatives have reached over 1500 participants. Additionally, we’ve seen success with virtual onboarding of sites using sophisticated physician office-friendly software for easy test ordering, processing and delivery of test reports, as well as prompt customer service. We intend to take these same steps to ensure similar expansion outside of the U.S. and are looking forward to continued progress.”

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, the impact of COVID-19 on our operations, unexpected expenditures or assumed liabilities or other unanticipated difficulties resulting from acquisitions, implementation and results of research, development, clinical trials and studies, commercialization plans including but not limited to distribution arrangements in markets outside the United States, 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, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, reliance on third party distributors or sales organizations to process orders for our diagnostic tests especially in over-seas markets, 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 the anticipated benefits of the acquisition, unexpected expenditures or assumed liabilities that may be incurred as a result of the acquisition, unanticipated difficulties in conforming business practices, including accounting policies, procedures and internal controls, greater than estimated allocations of Oncocyte 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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