OncoCyte Corporation announced positive results from its key R&D Validation study demonstrating the accuracy of the Company’s DetermaVu™ liquid biopsy test for lung cancer. 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. 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. These results show that DetermaVuTM significantly exceeds the critical parameters necessary for use in lung cancer diagnosis and that DetermaVuTM clearly outperforms reported results from competitors’ tests and other clinical models. Based on this strong performance, OncoCyte believes that DetermaVuTM is the best-in-class lung cancer liquid biopsy diagnostic test. OncoCyte plans to make DetermaVuTM commercially available in the second half of 2019, with the goal of fundamentally changing the way lung cancer is diagnosed. Notably, OncoCyte obtained these results without including any clinical factors in the DetermaVu™ lgorithm, underscoring the strength of the test. DetermaVu™ measures biomarkers of the immune system’s response to cancer to differentiate between malignant and benign lung nodules in early stage lung cancer. Because clinical data points, such as lung nodule size, provide a significant amount of the diagnostic power for liquid biopsy lung cancer tests developed by other companies, the superior accuracy of DetermaVu™ independent of any clinical factors reinforces its strength as a differential diagnostic tool for early lung cancer detection, and provides physicians with significant biologic information that has not been available prior to DetermaVu™. 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. In practice, physicians could use a simple DetermaVu™ blood test to determine whether or not a patient’s lung nodule should be biopsied for cancer. If the DetermaVu™ test indicates a benign result, the patient can be monitored without a biopsy, eliminating the cost and safety risks of an invasive procedure. With 75% specificity, physicians could use DetermaVu™ to eliminate up to three quarters of unnecessary biopsies and their associated complications and deaths. These reduced costs and improved patient outcomes highlight DetermaVu™‘s value proposition for payers such as Medicare and health insurance companies. The R&D Validation study utilized the optimized biomarkers and algorithm that were previously identified in the Company’s recently completed Algorithm Development study, based on 700 patient samples. R&D Validation Study: DetermaVu™ demonstrated sensitivity of 90% (95% CI 82%-95%), and specificity of 75% (95% CI 68%-81%) in a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators, and without the use of clinical factors such as nodule size. Results are the first ever in a blinded prospective study to confirm OncoCyte’s approach of utilizing the immune system’s response to early stage cancer to provide a robust biological signal in blood that supports physicians in differentiating between malignant and benign lung nodules. These results are consistent with previous studies of DetermaVu™, even though this study achieved statistically equivalent results using biomarkers alone, without the use of clinical factors such as nodule size, further confirming the strength and robustness of the biomarkers in the assay. The Company’s immune system interrogation approach overcomes significant challenges and limitations associated with early stage lung cancer detection using other liquid biopsy approaches, such as circulating tumor cell and cell free DNA detection, which have failed to demonstrate sensitivity and specificity characteristics comparable to DetermaVu™, particularly in early stage lung cancer patients.