<0> Predictive BiosciencesSharon Martin, 781-402-1780 x246 </0>
Predictive Biosciences, an innovative developer of molecular diagnostic tests, today announced the publication of the Company’s clinical study for the CertNDx™ Bladder Cancer Assay for Recurrence Monitoring in . The manuscript, entitled “Noninvasive multianalyte diagnostic assay for monitoring bladder cancer recurrence” can be accessed online at .
Predictive Biosciences conducted a prospective, multicenter study led by principal investigator, Neal D. Shore, M.D., FACS, and Director of the Carolina Urologic Research Center. The study consisted of 733 patients from 29 sites throughout the U.S., primarily from community-based urology practices, who were undergoing monitoring for bladder cancer recurrence. As part of their surveillance, patients underwent cystoscopy and urine samples were analyzed using a combination of DNA (including mutational analysis and hypermethylation of NID2 and VIM genes) and protein (matrix metalloproteinase-2) biomarkers. When compared to cystoscopy and biopsy results, the Company’s unique approach of combining biomarkers resulted in a high negative predictive value of 97.5% at a sensitivity of 90.5% to help identify patients who had a low likelihood of bladder cancer. The performance of mutational analysis alone resulted in a high specificity of 95.5% and positive predictive value of 38.8% to identify patients with a high risk of recurrence.
“This is our second published clinical study that validates the performance of the CertNDx Bladder Cancer Assay,” said Anthony P. Shuber, chief technology officer. “We believe CertNDx testing can have a tremendous impact on the way bladder cancer patients are managed and treated.”
The CertNDx Bladder Cancer Assay for Recurrence Monitoring is part of Predictive Biosciences’ comprehensive line of molecular diagnostic tests for bladder cancer. To learn more about CertNDx testing please visit: .
Predictive Biosciences develops novel molecular diagnostic cancer assays and provides molecular pathology services for urology-based practices. Leveraging a portfolio of patented biomarkers and clinical approaches, the company has built a unique portfolio of assays for cancer management, first targeted at bladder and prostate cancer. For additional information, please visit .