Predictive Biosciences introduces the next generation sequencing (NGS) into the company’s CertNDx™ bladder cancer tests.

The company has developed a new, highly sensitive, noninvasive, urine-based assay that uses NGS to analyze FGFR3 mutations for bladder cancer detection, which demonstrated a significant improvement in sensitivity over the qPCR method currently used in Predictive’s CertNDx Bladder Cancer Assays.

Predictive Biosciences has been awarded a National Academy of Clinical Biochemistry (NACB) Distinguished Abstract Award for the development of this assay and will present their research in a poster entitled, “Next-Gen Deep Sequencing Improves FGFR3 Detection in the Urine of Bladder Cancer Patients” on July 18, at the upcoming American Association for Clinical Chemistry (AACC) Annual Meeting in Los Angeles.

Predictive is working with the Life Technologies Ion Personal Genome Machine™ (PGM™) Sequencers in Predictive’s CLIA laboratory in Cleveland. “We believe that our proprietary method of combining protein and DNA biomarkers powered by highly sensitive next-generation sequencing is the first of its kind,” states Anthony P. Shuber, chief technology officer. “Creating biological fluid-based diagnostic tests on platforms such as the PGM that have sensitivity comparable to tissue-based analyses brings us closer to true liquid pathology.”

Marc Schneebaum, chief executive officer, added, “Implementation of NGS technology is a compelling initiative for Predictive, both increasing clinical performance and reducing assay costs. Attractive margins, together with the large market opportunities, make this an excellent platform for future IVD kit development, and we are actively pursuing partnerships on this front.”

Source: Predictive Biosciences