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Having recently achieved very positive results from its R&D Validation study,
The Analytical Validation Study is designed to establish performance characteristics of the assay system, which will then be validated in the Company’s CLIA-certified laboratory in
Results of R&D Validation study of DetermaVu™
OncoCyte’s recently-completed R&D Validation study of DetermaVu™ demonstrated sensitivity of 90% (95% CI 82%-95%) and specificity of 75% (95% CI 68%-81%) on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators. These results were achieved without including any clinical factors in the DetermaVu™ algorithm, and significantly exceed the critical parameters the Company believes are necessary for use in lung cancer diagnosis. Sensitivity is the percentage of malignant nodules that are correctly identified and specificity is the percentage of benign nodules correctly identified. A 95% confidence interval (CI) suggests that there is a 95% chance that final test performance will be within the stated range.
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.
DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a recent
DetermaVu™ is a trademark of
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
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