On January 30, 2019 BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported 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 (Press release, BioTime, JAN 30, 2019, View Source;p=RssLanding&cat=news&id=2385346 [SID1234532977]). 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.
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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.