Predictive Biosciences, Lexington, Mass, a developer of molecular diagnostic tests, announced the publication of the its clinical study for the CertNDx™ bladder cancer assay for recurrence monitoring in Research and Reports in Urology.
The manuscript, titled “Noninvasive multianalyte diagnostic assay for monitoring bladder cancer recurrence” can be accessed online at Dovepress.
The company conducted a prospective, multicenter study led by principal investigator, Neal D. Shore, MD, FACS, and director of the Carolina Urologic Research Center.
The study consisted of 733 patients from 29 sites throughout the US, primarily from community-based urology practices, who were undergoing monitoring for bladder cancer recurrence.
As part of their surveillance, patients underwent cystoscopy and their urine samples were analyzed using a combination of DNA (including FGFR3 mutational analysis and hypermethylation of NID2 and VIM genes) and protein (matrix metalloproteinase-2) biomarkers.
When compared to cystoscopy and biopsy results, the 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 FGFR3 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.
[source: Predictive Biosciences]