The new CertNDx(TM) Bladder Cancer Assay incorporating TP53 is expected to be commercially available in early 2013.
Predictive's next-generation sequencing assay for TP53 can detect 133 different mutations previously identified in bladder cancers. A research study conducted on 200 control samples and 36 cancers, incorporating TP53 sequence analysis into the existing assay, demonstrated an improvement over the previously published test by increasing sensitivity across bladder cancer pathways while retaining very high specificity and high Positive Predictive Value (PPV). The performance of this assay will also be validated in a large, prospective clinical trial to be completed in the first quarter of 2013.
The CertNDx test now fully incorporates the different pathways of bladder cancer. One pathway consists of primarily low-grade cancers, which are characterized predominantly by mutations in FGFR3. A second pathway consists of mostly high-grade cancers or carcinoma in situ lesions, which typically have mutations in TP53. These TP53 mutant tumors are more likely to be associated with a more aggressive clinical course and a very high likelihood of progression to a life threatening disease.
"By combining p53 with our current FGFR3 assay, we can provide excellent detection for both pathways, covering all stages and grades of bladder cancer," said Anthony P. Shuber, Chief Technology Officer. "In addition to incorporating p53 into the existing CertNDx assay, we are developing a version of the assay which integrates all of the CertNDx biomarkers in a format which can be run on any NGS platform, making it ready for in vitro diagnostic kit development."
Marc Schneebaum, Chief Executive Officer, added, "We are very excited that p53 further optimizes the performance of our NGS-based CertNDx test. This evolution of our test provides another compelling example of how Predictive's unique diagnostic approach and portfolio of clinically validated biomarkers leverages the ongoing innovation in NGS platform technology to add true clinical value."