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OncoCyte Announces Successful Completion of Analytical Validation Study and Commencement of CLIA Validation Study

1161 Days ago

Company remains on-track for DetermaVu™ commercial availability in 2H 2019

ALAMEDA, Calif., April 25, 2019 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, today announced the successful completion of the Company’s Analytical Validation study and the commencement of a CLIA Validation study of DetermaVu™, its liquid biopsy test for lung cancer.

The Analytical Validation Study was designed to establish performance characteristics of the ThermoFisher Next-Generation Sequencing assay system in OncoCyte’s Clinical Laboratory. The studies required for Analytical Validation have been established in the CLSI (Clinical Laboratory Standards Institute) Guidelines. These guidelines cover the testing for such matters as limits of quantitation, precision, reproducibility, and interfering substances. OncoCyte has completed all of these studies successfully. The Analytical Validation data supports the robust performance of DetermaVu™, previously demonstrated in the R&D Validation study earlier this year.

Lyndal Hesterberg, Ph.D., Senior Vice President of Research and Development, commented, “The successful completion of the Analytical Validation study confirms the analytical performance of the ThermoFisher Next Generation Sequencing System used for DetermaVu™, and builds upon our recently announced positive R&D Validation data. Together, these studies demonstrate our progress in advancing DetermaVu™ from scientific, technical and operational perspectives as we proceed to commercialization.”

William Annett, President and Chief Executive Officer of OncoCyte, added, “We are pleased to have successfully completed the Analytical Validation study, a key accomplishment on the path towards commercializing DetermaVu™. Our CLIA Validation study is now underway, and we intend to rapidly and efficiently move into the final study, Clinical Validation, with the goal of commercializing DetermaVu™ in the second half of this year. We believe OncoCyte’s Immune System Interrogation approach is a significant advancement in the diagnosis of lung cancer and we are committed to bringing DetermaVu™ to patients and doctors as soon as possible.”

The Company also announced today the initiation of its CLIA Validation study. In this study, OncoCyte is assaying approximately 120 samples previously tested in its R&D Validation study, with the goal of demonstrating that the same positive results can be obtained in the Company’s CLIA validated laboratory.  The CLIA Validation study includes specific protocols to confirm the accuracy, reproducibility, and precision/repeatability of DetermaVu™.

The final study, Clinical Validation, will commence upon successful completion of the CLIA Validation study. Importantly, OncoCyte already has in-house all required blood samples, allowing for the efficient completion of these remaining studies.

About DetermaVu™

DetermaVu™ is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on market penetration and reimbursable pricing.

DetermaVu™ is a trademark of OncoCyte Corporation.

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 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, and 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 as 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.

Investor Contacts

Bob Yedid
LifeSci Advisors, LLC

Media Contact

Andrew Mielach
LifeSci Public Relations

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