Oncocyte Announces Peer-Reviewed Publication of Data Demonstrating the Potential of its TNBCType Assay to Inform Triple Negative Breast Cancer Drug Development

Peer reviewed research demonstrates the utility of the Oncocyte’s TNBCType-IM assay to identify the most suitable cell lines to help biopharma and academic researchers in their quest for treatments for TNBC, the deadliest form of breast cancer

Published research demonstrates the test’s ability to work consistently both in vitro and in vivo in six cell lines used in drug development, suggesting promise in research applications

IRVINE, Calif., May 05, 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 peer-reviewed publication of data underscoring the potential of its TNBCType assay for use in triple negative breast cancer (TNBC) pharmaceutical research. The paper, entitled “”, was written by collaborators at The University of Texas MD Anderson Cancer Center and demonstrates the ability of the assay to work consistently across six cell lines typically used in drug development, both in vivo and in vitro. The findings were published in the peer-reviewed journal PLOS One.

Breast cancer is the most common cancer with more than 1.6 million new cases diagnosed annually in the world. In the United States, the overall 5-Year survival rates in breast cancer are over 90%, but survival rates for triple negative breast cancer (TNBC) are lower at 77%. TNBC is generally more aggressive than other types of breast cancer and is the focus of intense research by biopharmaceutical companies with over 100 clinical trials and several discovery-phase programs in process. TNBCType-IM is a 101 gene assay that measures the amount of RNA from a biopsy or surgical specimen and then uses a proprietary algorithm to classify patients into five subtypes associated with response to four different types of therapeutics including immune-therapy (PD-1/PD-L1), targeted therapies (PARP inhibitors and AR receptor) and cytotoxic chemotherapy. The Company believes that the assay may be an attractive companion diagnostic candidate for proprietary therapeutics in development at biopharmaceutical companies.  

In the study, researchers established tumor xenografts from 17 TNBC cell lines that were then subjected to gene expression profiling with a 2188-gene algorithm, TNBCType, and Oncocyte’s revised 101-gene algorithm TNBCtype-IM. A total of six cell lines were identified as maintaining consistent subtype classification between in vitro and in vivo tumor xenograft analyses by Oncocyte’s TNBCtype-IM algorithm, suggesting they may be the optimal cell lines for use in subtype specific TNBC drug development and translational research.

Naoto Ueno, M.D., Ph.D., Professor of Breast Medical Oncology at MD Anderson Cancer Center and the lead author of the study, said, "In developing new therapies for TNBC, it is important to have cell lines that are stable both in vitro and in vivo to show the drug’s effectiveness.  This research will help pharma and academic researchers know which cell lines to use to identify the most promising therapeutic candidates to personalize the cancer treatment in TNBC."

“The data published in this manuscript reinforce the potential clinical importance of TNBC classification,” added Doug Ross, M.D., Ph.D., Chief Medical Officer of Oncocyte. “This information will help  bridge the gap between drug development and the potential use of TNBCtype for making clinical decisions.”

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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