Predictive Biosciences Announces Publication of Hematuria Clinical Study in Mayo Clinic Proceedings
<0> Predictive BiosciencesSharon Martin, 781-402-1780 x246 </0>
Predictive Biosciences, an innovative developer of molecular diagnostic tests, today announced the publication of a prospective, multicenter study of the Company’s CertNDx™ Bladder Cancer Assay for Hematuria Assessment in the online edition of . The manuscript, entitled “A Noninvasive Multianalyte Urine-Based Diagnostic Assay for Urothelial Cancer of the Bladder in the Evaluation of Hematuria” will also appear in the upcoming September 6, 2012 print edition. The article can be accessed at .
Predictive Biosciences conducted a prospective, multicenter study led by principal investigator, Dr. R. Jeffrey Karnes of Mayo Clinic, to determine whether a noninvasive urine-based assay using protein and DNA biomarkers could stratify patients based on their likelihood of having bladder cancer. The population consisted of 748 patients presenting with hematuria from 27 sites throughout the U.S., primarily from community-based urology practices. As part of their evaluation, patients underwent cystoscopy and urine samples were analyzed using a combination of DNA (including mutational analysis) and protein (matrix metalloproteinase-2) biomarkers. When compared to cystoscopy and biopsy, the Company’s unique approach of combining biomarkers resulted in a high negative predictive value of 98.2% at a sensitivity of 87.5% to help identify patients who are unlikely to have bladder cancer. The performance of mutational analysis alone resulted in a high specificity of 99.9% and positive predictive value of 95.2% to help identify patients with bladder cancer.
“This publication is the first study of its kind to show the robust performance a multianalyte assay can provide in diagnosing and monitoring bladder cancer,” said Anthony P. Shuber, chief technology officer. “The ability to triage patients based on their likelihood of disease can help improve patient management by accelerating intervention for those at high risk and avoiding unnecessary and invasive procedures for those at low risk.”
The CertNDx Bladder Cancer Assay for Hematuria Assessment 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 .
Mayo Validation Support Services, an affiliate of Mayo Clinic, based in Rochester, Minn. assists pharmaceutical, biotechnology and diagnostic companies in validating the clinical significance of emerging biomarkers and technologies. Mayo’s contribution of well-annotated biospecimens and clinical follow-up data support the development of individualized medicine, one of Mayo’s strategic initiatives.