BioCentury
ARTICLE | Company News

Predictive Biosciences diagnostic news

June 3, 2013 7:00 AM UTC

Predictive Biosciences is ceasing operations and laying off all 91 employees after CMS contractor CGS Administrators LLC decided to deny coverage for the company's bladder cancer diagnostics. CEO Pierre Cassigneul told BioCentury that the company is not viable in the absence of Medicare coverage, noting that Medicare represents about half of the market for Predictive's CertNDx bladder cancer diagnostic tests and many private payers mimic Medicare's coverage and reimbursement policies. Predictive's three bladder cancer tests are marketed in the U.S. as laboratory-developed tests, which are not subject to FDA approval. The company's CertNDx Bladder Cancer Assay is a non-invasive diagnostic urine test combining matrix metalloproteinase 2 (MMP2), fibroblast growth factor (FGF) receptor 3 ( FGFR3; CD333), twist homolog 1 (TWIST1) and nidogen-2 (NID2) biomarkers.

According to the company, CGS Administrators stopped paying claims for the company's tests in January. Predictive Biosciences said CGS Administrators had previously been reimbursing about $380 per test. In April, CGS informed Predictive that resumption of coverage would be contingent on the company producing evidence of clinical utility. Cassigneul said a study to demonstrate the utility of CertNDX to predict bladder cancer recurrence could take two years to conduct, and "our investors are not willing to go further in supporting the company." CGS said in a comment that it does not recommend or require studies or clinical trials as a means of providing evidence of clinical utility. The contractor also said it has followed the CMS process for molecular pathology coverage and pricing and, if more evidence is made available or developed, it will review and reassess its coverage determination. ...