On September 27, 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 that its CLIA laboratory has successfully completed a rigorous validation study of DetermaVu, OncoCyte’s diagnostic test for lung cancer (Press release, BioTime, SEP 27, 2017, View Source [SID1234520663]). In this study, OncoCyte assayed approximately 120 samples previously tested in its 299-patient study presented at the American Thoracic Society conference in May 2017, with the goal of demonstrating that OncoCyte’s new clinical laboratory provides the same results on clinical samples as those obtained in its R&D lab. The results met all performance criteria, demonstrating the accuracy and robustness of the assay as performed in the Company’s CLIA laboratory. The CLIA lab validation study included specific protocols to confirm the accuracy, reproducibility, and precision/repeatability of DetermaVu.

“The laboratory staff and procedures in place in the clinical laboratory have been confirmed to provide accurate, reliable, consistent and reproducible results,” said William Seltzer, PhD, FACMG, VP of Clinical Services and the Laboratory Director for OncoCyte. “The results were consistent with the positive data reported at the American Thoracic Society 2017 International Conference, and have enabled us to initiate our Clinical Validation Study, the final step prior to the commercial launch of DetermaVu.”

The Clinical Validation Study has now begun and is expected to be completed in the fourth quarter of 2017. In this study, approximately 300 new blinded blood samples, which have been prospectively collected will be assayed in the CLIA lab using DetermaVu. The performance of the test will be assessed against the clinical diagnosis of the patients from whom the samples were collected. If the Clinical Validation Study is successful and the results meet commercial requirements, OncoCyte will commence the commercial launch of DetermaVu.

“Successful completion of the CLIA Lab Validation Study is another important step toward launching DetermaVu,” said William Annett, President and Chief Executive Officer. “We plan to complete the ongoing Clinical Validation Study in the fourth quarter.”

OncoCyte believes that widespread utilization of DetermaVu could result in a substantial reduction in the number of unnecessary, expensive lung biopsies performed annually in the U.S., with a corresponding reduction in the surgical risk to patients undergoing biopsy procedures. Broad use of DetermaVu would result in a fundamental advancement in the diagnosis of suspicious lung nodules by allowing physicians to determine more accurately which patients need biopsies and which patients only need follow-up imaging. The Company estimates that approximately 1.4 million patients annually in the U.S. could benefit from the DetermaVu test. Depending on market penetration and reimbursable pricing, this could translate into a market opportunity of up to $4.7 billion annually.