CertNDx™ Case Study Published in BMC Urology

LEXINGTON, Mass.--(BUSINESS WIRE)--Predictive Biosciences, an innovative developer of molecular diagnostic tests, announced today that a case study using the CertNDx™  Bladder Cancer Assay was published in BMC Urology by Dr. Daniel M. Silverberg of Urology Specialists of the Lehigh Valley in Allentown, PA. The article entitled “Urothelial carcinoma of the upper urinary tract diagnosed via FGFR3 mutation detection in urine: a case report” can be accessed online at BMC Urology.

“The CertNDx Bladder Cancer Assay was instrumental in diagnosing an upper urinary tract urothelial carcinoma that was difficult to detect by cytology and endoscopy”

FGFR3 mutations have been shown to exist in up to 50% of cancers found in the urinary bladder and upper urinary tract, but only a handful of research institutions throughout the world have attempted to detect them. With the introduction of the CertNDx Bladder Cancer Assay, a non-invasive molecular diagnostic test, urologists across the United States now have the ability to detect bladder and upper urinary tract cancers using FGFR3 mutation detection in urine. This case demonstrates the CertNDx Bladder Cancer Assay’s ability to detect an upper tract cancer in a real-world medical practice.

The case reports on a 73-year old man who presented with an abnormality seen near the right kidney, found incidentally after radiographic imaging for another purpose was performed. Routine workup including urine cytology and cystoscopy were found to be negative. The CertNDx Bladder Cancer Assay was positive for an FGFR3 mutation present in the urine. Based on the positive test result, additional follow-up detected a tumor in the right renal pelvis (central region near the right kidney). The tumor was surgically removed and the tumor tissue was analyzed for FGFR3 mutations and the same FGFR3 mutation in the tissue was identified in the urine.

“The CertNDx Bladder Cancer Assay was instrumental in diagnosing an upper urinary tract urothelial carcinoma that was difficult to detect by cytology and endoscopy,” said Dr. Angelo De Marzo, chief medical officer of Predictive Biosciences. “This is a powerful example of how CertNDx testing can be used not only for bladder cancer but to help detect upper tract disease that may be missed using traditional diagnostic tools.”

About Predictive Biosciences

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 www.predictivebiosci.com.