Predictive Biosciences this week announced the completion of a $25 million Series C funding round.
The proceeds will be used to complete multi-center trials for Predictive's CertNDx bladder cancer diagnostic and for the commercial launch of the test through its CLIA certified laboratories, the company said in a statement.
As opposed to most cancer biomarker tests, CertNDx focuses on negative predictive value – the probability that a patient who has tested negative for cancer is actually free of the disease. This is of particular utility for bladder cancer given that post-treatment, patients typically must receive regular cystoscopies for the rest of their lives in order to test for recurrence.
The CertNDx test combines the use of urinary matrix metalloproteinases – a family of zinc-dependent endopeptidases associated with certain cancers – as protein biomarkers with a real-time PCR assay for detecting mutations in fibroblast growth factor receptor 3 in urine samples. MMPs are associated with high-grade invasive tumors, while FGFR3 mutations are associated with low-stage, non-invasive tumors. Combining the two tests improves the negative predictive value of the CertNDx diagnostic from 94 percent with the MMP-based assay alone to 97 percent, the company concluded in a poster presented in December 2009 at the 10th Annual Meeting of the Society for Urologic Oncology.
Investors in the round included the company's previous investors Flybridge Capital Partners, Highland Capital Partners, Kaiser Permanente Ventures, and New Enterprise Associates, along with new investor ProQuest Investments.
In addition to funding development and commercialization of the CertNDx test, the money will be used to fund the expansion of OncoDiagnostic Laboratory, the anatomic pathology lab services firm the company acquired in January.