LEXINGTON, Mass.--(BUSINESS WIRE)-- Predictive Biosciences today announced that the Company will be presenting an update on its non-invasive diagnostic assays for bladder cancer detection during the GTCbio’s Oncology Biomarkers Conference, being held January 27 – 28 in San Diego, CA. The conference focuses on topics paramount to the continuing progress of biomarker research and development.
Anthony P. Shuber, Predictive’s chief technology officer and co-founder, will present “A Novel Approach Utilizing Urinary Biomarkers for Managing Bladder Cancer Patients” on Thursday, January 27 at 2:25 p.m. PST. The approach known as the Multi-Analyte Diagnostic Readout (MADR) combines protein and DNA biomarkers in one assay to identify with high certainty a group of bladder cancer patients who are disease free and could be excluded from undergoing invasive procedures.
Predictive found that the combination of four biomarkers (MMP-2, FGFR3, TWIST1 and NID2) in its bladder cancer assay resulted in 94 percent sensitivity with a 99.5 percent negative predictive value (NPV). NPV is the probability that a patient who has tested negative for cancer is free of the disease. This approach is the basis for the CertNDxTM Bladder Cancer Assay to be used initially for hematuria assessment. Predictive’s CertNDx™ Bladder Cancer Assay includes DNA methylation biomarkers, TWIST1 and NID2, recently in-licensed from partner MDXHealth SA.
“Our CertNDx tests provide a new, highly reproducable tool to aid in the clinical management of bladder cancer.” remarked Anthony Shuber. “Patients identified as cancer-free during evaluation could forego unnecessary, invasive treatment that could lead to improved patient care and reduced healthcare costs.”
The MADR approach is being utilized by Predictive in the development of its CertNDx line of cancer assays, and is an extension of Predictive’s Clinical Intervention Determining Diagnostic (CIDD™) approach. CIDD was developed by Predictive to identify biomarker cutoffs that maximize negative predictive value in order to identify with very high certainty those who require no further intervention. Predictive has recently launched the first CertNDx Molecular Grading Assay, a tissue-based test that provides definitive diagnostic and prognostic information for bladder cancer detection.
About Predictive Biosciences
Predictive Biosciences is a fully-integrated developer of novel molecular diagnostic cancer assays and a urology-focused provider of anatomic pathology laboratory products and services. Leveraging a portfolio of patented biomarkers and clinical approaches, the company is building a unique portfolio of assays for cancer management, first targeted at bladder and prostate cancer. Predictive Biosciences’ commercial division, OncoDiagnostic Laboratory (ODL), is a Clinical Laboratory Improvement Act (CLIA)-certified anatomic pathology and molecular diagnostics lab with a national sales force serving urologists and other subspecialty physicians. For additional information, please visit www.predictivebiosci.com.
Sharon Martin, +1 781-402-1780 x246
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Other Health Research Science