OncoCyte Corporation has reported the successful completion of a critical step in the development of its blood-based lung cancer diagnostic test. While the key performance metrics of its diagnostic cannot be revealed until they are presented at the American Thoracic Society meeting in May, the company has locked its prediction algorithm and intends to move to the clinical validation phase of development—the last phase before commercial launch. The data from the study exceed levels that OncoCyte believes necessary for a commercially successful test, and the company is moving forward with plans to launch the lung cancer diagnostic test during the second half of 2017.
OncoCyte’s algorithm confirmed the results of an earlier study by The Wistar Institute of Anatomy and Biology, which reported its results at the CHEST 2016 annual meeting in October 2016. The area under the curve (AUC) in the Wistar study was 0.82, with a sensitivity of 90% and specificity of 62%. OncoCyte’s study results were consistent with Wistar’s.
The AUC of a test is a measure that combines sensitivity and specificity to express its total accuracy, with 1.0 being perfect accuracy and 0.50 being a random result. 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.
OncoCyte believes that its blood-based lung cancer test can provide Medicare and private insurance companies with significant savings if the price of its product is approximately 20% to 25% of the cost of an invasive lung biopsy, which averages approximately $15,000, according to recent Medicare estimates.
Source: OncoCyte Corporation; March 6, 2017.