Blinded Validation Projectfor Prostate Cancer Test Johns Hopkins University Medical Center, Brady Urology Institute

Summary
OTraces, in collaboration with the Johns Hopkins Medical Center, Brady Urology Institute (JHMC), performed a blinded validation study on OTraces prostate cancer (PCa) detection products. The blinded validation project involves two phases, and the first has been completed:

• Phase I: Blinded third party validation of the test for men with aggressive PCa, Gleason score of 7(4+3), 8, 9, and 10 against men without any form of PCa, not cancer. Accuracy of results for the blinded samples were 95% for sensitivity and specificity was 90% meeting the Phase I test design goals. Furthermore, the validation not cancer cohort samples included about 40 samples with PSA levels greater than the current biopsy cutoff of 4 ng/ml of the PSA in serum (as high as 124 ng/ml). All of these were called correctly as not cancer by the test, indicating that the problem with the current PSA test false positive rate has been completely solved.
• Phase II: Blinded third party validation of test for men with low grade, Gleason score of 5, 6, and 7(3+4) against men with aggressive PCa and men without PCa (not PCa cohort). This evaluation determined that the correlation method can separate low grade from high grade PCa to at about 95% predictive power. The JHMC derived aggressive PCa samples were also compared to a test sample cohort of men with low grade PCa, Gleason score 5, 6, and 7(3+4) that were collected from another source and run within OTraces labs to determine what Phase II results are likely to be.