OncoCyte, a developer of novel, non-invasive tests for the early detection of cancer, announced the initiation of the Company’s Analytical Validation study of DetermaVu Lung, its liquid biopsy test for lung cancer.
Having recently achieved very positive results from its R&D Validation study, OncoCyte is now working to complete the remaining development studies required for commercialization of DetermaVu, including Analytical Validation, CLIA Validation and Clinical Validation. Assuming positive results from these studies, the Company remains on-track to make its DetermaVu lung cancer assay commercially available in the second half of 2019.
William Annett, President and Chief Executive Officer of OncoCyte, stated, “We are very pleased to have initiated the Analytical Validation study, the next critical step toward the completion of development of DetermaVu. Importantly, we already have in-house all of the required patient blood samples, allowing us to advance efficiently through this study. We anticipate making DetermaVu commercially available later this year and believe our immune system interrogation approach has the potential to fundamentally change the way lung cancer is diagnosed.”
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 Alameda, California. The studies required for Analytical Validation are established in the Clinical Laboratory Standards Institute (CLSI) Guidelines. These guidelines cover the testing for such matters as limits of quantitation, precision, reproducibility, and interfering substances. Successful completion of the study will establish the performance characteristics of DetermaVu and if the upcoming CLIA Validation and Clinical Validation studies are successful, will allow for use under real world conditions.
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. 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 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 Medicare study, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.
DetermaVu is a trademark of OncoCyte Corporation.
Source: Company Press Release