NGS Improves Bladder Cancer Assay Sensitivity

Diagnosis of bladder cancer has been notoriously hampered by the low sensitivity of urine cytology even among patients presenting with hematuria. Complicating management efforts is the high rate of recurrence that necessitates invasive and costly long-term surveillance. Predictive Biosciences (Lexington, Mass.) believes that its CertNDx bladder cancer offerings can improve risk stratification of patients with hematuria and provide a better alternative for recurrence monitoring. Previous studies analyzed urine samples for levels of the protein (MMP-2), two methylation markers (Twist1/Nid2), and mutations of FGFR3 using quantitative polymerase chain reaction. In an abstract presented at the American Urological Association annual meeting (May 7; San Diego) investigators used a similar multianalyte assay but incorporated next-generation sequencing-based mutation analysis of TP53 and FGFR3. The new marker combination increased the identification of the cancer-negative patients from 56.2 percent to 67.9 percent while increasing sensitivity from 87.9 percent to 92.5 percent (99 percent negative predictive value). The combination of FGFR3 and TP53 increased the sensitivity for identifying patients likely to have cancer from 34.5 percent to 50.9 percent while maintaining specificity (99.7 percent), a 93.1 percent positive predictive value. The researchers say the results demonstrate that the assay can stratify patients with high confidence into those that do or do not have bladder cancer. For more information on diagnosis of bladder cancer please see Inside the Diagnostics Industry on page 5.