Predictive Biosciences Inc. today announced the publication of pilot study results in the November issue of the Journal of Urology, highlighting the Company’s novel urinary biomarker approach to bladder cancer detection that achieves exceptionally high Negative and Positive Predictive Values (NPV and PPV). The study demonstrates that Predictive’s unique non-invasive clinical approach, known as Clinical Intervention Determining Diagnostic™ or CIDD, can identify with extremely high confidence those patients who do not have bladder cancer. Based on the strength of these initial study results, Predictive has commenced two prospective clinical trials to evaluate its bladder cancer assay; each is to enroll approximately 1,000 subjects at 10 or more clinical trial sites.
As described in the Journal of Urology, Predictive’s novel CIDD approach was applied to optimize assay cutoffs for a non-invasive bladder cancer assay, using urinary matrix metalloproteinases (MMPs) as biomarkers. Researchers analyzed urine samples from 530 patients, including 84 with bladder cancer, for levels of urinary MMPs, the expression of which has been shown to highly correlate with disease status in bladder and other cancers. The pilot study results could lead to new, non-invasive and highly reliable tests that individualize diagnostic follow-up in patients undergoing surveillance for bladder cancer recurrence and in patients with hematuria (blood in the urine) undergoing evaluation for bladder cancer.