After raising over $30 million, and securing key channel access, Predictive Biosciences (developer of an LDT for bladder cancer) has closed operations because it couldn't afford the level of validation required by a payer.
From the article:
"Predictive Biosciences will cease to operate and will lay off 91 employees because an insurance company contracted by Medicare will no longer cover the company’s bladder cancer diagnostic, according to BioCentury. Center for Medicare & Medicaid Services administrators in January 2013 stopped paying claims for the CertNDx tests, CEO Pierre Cassigneul told BioCentury."
"In April 2013, CMS informed him that coverage would resume only when the company could provide evidence of clinical utility. Cassigneul said that meeting the request could take two years and that “our investors are not willing to go further in supporting the company.” Predictive Biosciences’ three bladder cancer tests were previously reimbursed at about $380 per test."