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ALAMEDA, Calif., June 26, 2019 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, today provided a mid-year update and announced that the Company will require additional time to complete its ongoing CLIA Validation study of DetermaVu™, its liquid biopsy test for lung cancer.
In the CLIA Validation Study, started in late April, OncoCyte is assaying approximately 120 samples previously tested in its R&D Validation study, with the goal of demonstrating that the same results can be obtained in the Company’s CLIA-validated laboratory. To complete a technology transfer from an R&D setting to full commercial production in a CLIA lab typically requires several components of workflow validation, including sample prep and sample extraction kits that can ultimately be automated. Due to ongoing efforts to create consistency in this process and to ensure the CLIA assay provides the most consistent, sensitive results for patients the company will continue its development work before releasing the final data.
William Annett, President and Chief Executive Officer of OncoCyte, added, “In an effort to maintain frequent updates for our shareholders, we wanted to address the mid-year timing previously committed to by management. Our talented R&D professionals and CLIA lab staff are working diligently to analyze and address the remaining steps needed to proceed with the CLIA Validation study. Once these teams have made progress with these remaining steps, management intends to provide an update on the timing of the key milestones for DetermaVu™.”
About OncoCyte Corporation
OncoCyte is focused on the development and commercialization of novel, non-invasive blood (“liquid biopsy”) diagnostic tests for the early detection of cancer. Early detection of cancer can improve health outcomes, reduce the cost of care, and improve patients’ quality of life. Liquid biopsy diagnostic tests like those OncoCyte is developing may reduce the need for costlier and riskier diagnostic procedures such as invasive biopsy procedures. OncoCyte is focusing its efforts on developing DetermaVu™ as a non-invasive confirmatory diagnostic test for lung cancer. DetermaVu™ is being developed using proprietary sets of genetic and protein molecular markers to detect the presence of lung cancer. OncoCyte also plans to conduct research to identify additional molecular markers, acquire or license markers and related technology, and develop cancer tests based on those markers.
OncoCyte 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” and similar expressions) are forward-looking statements. These statements include those pertaining to the time to complete and the results of the Company’s ongoing CLIA Validation study, 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, 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, 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. 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. OncoCyte disclaims any intent or obligation to update these forward-looking statements, except as required by law.
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