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BioTime Inc. Affiliate Company OncoCyte Corporation Reports Successful Results With DetermaVu Diagnostic Test for Lung Cancer
Globe Newswire 30-Jan-2019 8:00 AM
ALAMEDA, Calif., Jan. 30, 2019 (GLOBE NEWSWIRE) -- BioTime, Inc. (NYSE:BTX), a clinical-stage biotechnology company focused on degenerative diseases, today announced that its affiliate company, OncoCyte Corporation (OncoCyte) (OCX), a developer of novel, non-invasive tests for the early detection of cancer, has reported positive results from an R&D validation study of DetermaVu™, a non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. As outlined in OncoCyte's announcement, the R&D validation study demonstrated a sensitivity of 90% (95% CI 82%-95%) and specificity of 75% (95% CI 68%-81%) of DetermaVu™ on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators. A 95% confidence interval (CI) suggests that there is a 95% chance that test performance will be within the stated range.
According to OncoCyte, these results indicate that DetermaVu™ significantly exceeds the critical parameters necessary for use in lung cancer diagnosis and clearly outperforms reported results from competitors' tests and other clinical models. OncoCyte believes that the potential U.S. market opportunity for DetermaVu™ is $4.7 billion. OncoCyte intends to make DetermaVu™ commercially available in the second half of 2019.
"As the largest shareholder of OncoCyte, we wish to congratulate the entire team on obtaining positive results from the validation study of DetermaVu™ which were announced yesterday morning," stated Brian M. Culley, Chief Executive Officer of BioTime, Inc. "BioTime owns approximately 36% of Oncocyte's outstanding common stock and we look forward to the commercial launch of DetermaVu™ which OncoCyte expects to occur later this year."
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 a confirmatory test for presence or absence of lung cancer to reduce the need for unnecessary invasive biopsies when suspicious lung nodules are detected by imaging modalities such as x-rays or other scans. 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.
About BioTime, Inc. BioTime is a clinical-stage biotechnology company focused on the development and commercialization of novel therapies for the treatment of degenerative diseases. BioTime's pipeline is based on two platform technologies which encompass cell replacement and cell/drug delivery. BioTime's lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy in Phase 2 development for the treatment of dry age-related macular degeneration, the leading cause of blindness in the developed world. BioTime's lead cell delivery clinical program is Renevia®, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures. BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+. To receive ongoing BioTime corporate communications, please click on the following link to join the Company's email alert list: http://news.biotime.com.
Forward-Looking Statements Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of BioTime's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
