Multianalyte Approach Determines Presence or Absence of Bladder Cancer

A newly developed, noninvasive, urine-biomarker based diagnostic bladder cancer assay uses a multianalyte approach.

The bladder cancer assay utilized both matrix metalloproteinase (MMP) biomarkers and fibroblast growth factor receptor 3 (FGFR3) biomarkers, improving the sensitivity and specificity achieved by each.

The Predictive Biosciences (Lexington, MA, USA) MADR method is an extension of its Clinical Intervention Determining Diagnostic (CIDD) approach to the noninvasive management of bladder and other cancers. The noninvasive, urine-biomarker based diagnostic assay multianalyte approach was presented during the 10th Annual Meeting of the Society of Urologic Oncology (SUO), which took place on December 2-4, 2009 at the Natcher Conference Center of the National Institutes of Health (NIH; Bethesda, MD, USA).

MMPs detected in urine as monitors of disease-free status identified with high confidence--as measured by negative predictive value (NPV)--the bladder cancer participants who did not have cancer recurrence at the time of evaluation. By adding a real time polymerase chain reaction (RT-PCR)-based assay to detect FGFR3 mutations as monitors of disease recurrence, Predictive was able to further increase the assay's NPV, with no reduction in specificity.

FGFR3 gene mutations, detectable in the urine of bladder cancer patients, are associated with early stage/early grade bladder cancer with up to 70% of low-grade tumors showing mutation. Inclusion of this binary DNA biomarker in its bladder cancer assay helps to detect lower stage/grade bladder cancers, which have been difficult to detect with other biomarkers.

Anthony P. Shuber, cofounder and chief technology officer for Predictive Biosciences, commented, "Carried forward into the clinical setting, we are aiming to provide urologists with a noninvasive diagnostic tool that we anticipate will initially be used in tandem with current standard-of-care approaches such as cystoscopy, cytology and upper urinary tract imaging. Ultimately, our goal would be for physicians to use the test as an actionable tool prior to cystoscopy. We believe it will allow them to confidently triage patients by those who are highest risk and require accelerated intervention, those who are average risk and should receive standard-of-care, and importantly, those who are at very low risk and can forgo cystoscopy.”

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