On September 18, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive blood-based liquid biopsy tests to assist in the early detection of cancer, reported positive final results from the Analytical Validation Study of its liquid biopsy lung cancer diagnostic test, DetermaVU (Press release, BioTime, SEP 18, 2017, View Source [SID1234520552]). The data were presented by Philip McQuary Ph.D., Director of Product Development, OncoCyte Corporation, at the International Association for the Study of Lung Cancer (IASLC), in Chicago.
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The accuracy results of the Analytical Validation Study reported today demonstrate sensitivity of 94.4%, specificity of 67.5% and Area Under the Curve (AUC) of 0.93, which means that 93 percent of the samples tested during the Analytical Validation were correctly diagnosed. These data are consistent with the data reported in May at the American Thoracic Society 2017 International Conference.
Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified. The AUC of a test is a measure of overall global accuracy that combines sensitivity and specificity, with 1.0 being perfect accuracy and 0.50 being a random result. The score of 0.93 reported at the recent IASLC meeting means that 93 percent of the samples were correctly identified.
The next step in the process leading to commercial launch of DetermaVu is a CLIA Validation study, which is now underway and expected to be completed in the third quarter of this year. If the CLIA Validation study is successful, the final step will be a Clinical Validation study, which is expected to be completed in the fourth quarter of this year. If the Clinical Validation study is successful, OncoCyte plans to launch DetermaVu. OncoCyte believes that at launch DetermaVu will be the only commercially available liquid biopsy lung cancer product in what the Company estimates is an up to $4.7 billion annual market opportunity in the U.S.
"The new data seen in the Analytical Validation Study provide further evidence of the reliability of the DetermaVu assay system in identifying cancerous nodules," stated Lyndal Hesterberg, Ph.D., Senior Vice President, Research and Development. "These data give support our belief that physicians will be able to use DetermaVu with confidence in their clinical practice to help patients make more informed treatment decisions."
William Annett, President and Chief Executive Officer, commented, "We are excited that the results reported at the IASLC conference confirm the positive data reported in May at the American Thoracic Society meeting. If our upcoming Clinical Validation study is successful, we intend to commercialize DetermaVu in the fourth quarter of 2017."
Analytical Validation
The studies required for Analytical Validation have been established in the CLSI (Clinical Lab Standards Institute) Guidelines. These guidelines cover the testing for such matters as limits of quantitation, precision, reproducibility, and interfering substances. OncoCyte has completed all of these studies successfully.
The new Analytical Validation data support expectations that the test’s performance will continue to be robust. The completion of the study establishes the performance characteristics of OncoCyte’s lung cancer diagnostic test and, if the Clinical Validation studies are successful, will allow for industrial-scale operations under real world conditions.
OncoCyte believes that DetermaVu could result in a substantial reduction in the number of unnecessary, expensive lung biopsies performed annually in the U.S., thereby representing a fundamental advancement in the more accurate diagnosis of suspicious lung nodules by allowing physicians to determine which patients need biopsies versus those who may only need follow-up imaging. The Company estimates that approximately 1.4 million patients annually in the U.S. could benefit from the test. Depending on market penetration and reimbursable pricing, this could translate into a market opportunity of up to $4.7 billion annually.
Clinical Validation Stage Underway
The final stage of development following the now completed Analytical Validation Study is Clinical Validation. This stage consists of two distinct sets of studies that will be carried out in OncoCyte’s new CLIA approved clinical laboratory. The first step is CLIA Lab Validation. In this study, OncoCyte will assay approximately 120 samples previously tested in the 299-patient study presented at the ATS meeting, with the goal of demonstrating that OncoCyte’s new clinical laboratory provides the same results on clinical samples as those obtained in OncoCyte’s R&D lab. This study is underway.
Upon successful completion of the CLIA Lab Validation study, the second step will be two CLIA Lab Clinical Validation studies. In these studies, OncoCyte will perform assays on blinded prospectively collected samples to assess the performance of the full diagnostic system against clinically confirmed diagnoses. OncoCyte will perform Clinical Validation on two sets of samples. The first study will consist of approximately 300 samples. If the results of the study are consistent with results to date, OncoCyte will launch DetermaVu.
The second study will be conducted post-launch on approximately 200 additional samples to provide additional data to increase the likelihood that physicians will adopt the test and that insurance companies and Medicare will provide reimbursement coverage for the test.