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BioTime's subsidiary OncoCyte announced Monday that study results of the company's blood test for the early detection of lung cancer confirmed the accuracy reported from a prior trial, adding that the data "exceed levels believed necessary for a commercially successful test." OncoCyte further said that it "has locked its prediction algorithm and intends to move to the clinical validation phase of development," and is "moving forward with plans to launch the lung cancer diagnostic test during the second half."
OncoCyte CEO William Annett remarked that "our goal is to have the first commercial blood test that can help physicians to better manage patients presenting with lung nodules, and to avoid a significant number of risky and costly biopsies." The company noted that its product would be priced at about 20 percent to 25 percent of the cost of an invasive lung biopsy, while the addressable market for the test "could potentially exceed $4 billion."
Specifically, the study developed and tested OncoCyte's algorithm, using around 300 samples collected from patients with nodules ranging in size from 5 mm to 30mm. According to the company, the algorithm confirmed the results of an earlier study that were presented at the CHEST 2016 annual meeting, in which the area under the curve (AUC) was 0.82 with a sensitivity of 90 percent and specificity of 62 percent. OncoCyte said the latest study results, which will be presented at the American Thoracic Society conference in May, were consistent with the earlier study data.
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