Results of Key R&D Validation Study expected in January
ALAMEDA, Calif., Dec. 20, 2018 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, today announced that it has run all of the 700 samples required for its Algorithm Development Study, which is intended to derive the proprietary mathematical algorithm that will be used to interpret the results of the DetermaVu™ assay. The data from the samples is being analyzed by biostatisticians who are developing the algorithm, and once completed and optimized, OncoCyte will use the algorithm to carry out its R&D Validation study.
The Company has also run the 250 blinded, prospectively-collected patient blood samples to be used for its R&D Validation study, which is designed to confirm the performance of the proprietary algorithm on a blinded set of samples. Once the proprietary mathematical algorithm is available it will be used to interpret the data from these 250 samples. Results of the R&D Validation Study, which should determine the accuracy of DetermaVu™ to within approximately plus or minus eight percentage points, are expected in January. This study is critical because if successful it will be the first confirmation in a blinded study of the performance that can be expected of DetermaVu™ in the clinical setting.
“We look forward to receiving results soon from our R&D Validation study, which should be indicative of final test performance and, if positive, should indicate that it has sufficient sensitivity and specificity to warrant completion of development for commercialization of DetermaVu™ in the market,” said William Annett, President and Chief Executive Officer. “The remaining validation pathway for DetermaVu™ is straightforward and efficient, and assuming positive results from those remaining studies, we remain on-track for having DetermaVu™ commercially available in the second half of 2019. We believe DetermaVu™ can address a multi-billion dollar market opportunity while reducing the number of risky and expensive unnecessary lung biopsies.”
DetermaVu™ is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu™ is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (including low-dose computed tomography, 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 and urine (“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’s 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.
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