NEW YORK (GenomeWeb News) - The Critical Path Institute plans to launch a new organization in the coming months to assess the performance of diagnostics before they are submitted to the US Food and Drug Administration for evaluation, according to a C-Path Institute official.
The new non-governmental, non-profit organization, which would provide a non-required test evaluation service to companies and have no enforcement power, will also aim to help smooth the regulatory interaction between diagnostic companies and the agency. It also could potentially help clear up confusion over regulations governing multi-analyte tests.
Jeffrey Cossman, chief scientific officer of the C-Path Institute, told GenomeWeb Daily News sister publication Pharmacogenomics Reporter this week that the new group, to be called United States Diagnostics Standards, would function as a kind of underwriter for diagnostics firms.
“Companies already submit their tests to data tests site for evaluation prior to FDA submission,” Cossman said. “This would take the place of a data test site.”
The organization, which would be funded by industry user fees, would initially operate under the C-Path Institute, but would eventually become an independent entity. “The idea is to remain neutral and assist companies through the regulatory process. The idea is not to be a hurdle,” Cossman said.
The launch of USDS is one aspect of C-Path Institute’s larger goal of helping FDA standardize the evaluation of diagnostic tests.
“There may be a role here for establishing an entity that could provide a means for standardizing the testing of diagnostics before they are submitted to the FDA,” Cossman said last month during a meeting of the HHS Secretary’s Advisory Committee on Genetics, Health, and Society.
Diagnostic companies will pay USDS to assess their tests under a user-fee system similar to the FDA’s regulatory process. Following a USDS review, however, the company will own the data and is free to use it for FDA submissions, internal data, marketing, or in conversations with insurers.
“For lab-developed tests such as genetics, which may not end up being submitted to the FDA as an in vitro diagnostic, it could be used to evaluate those as well so that providers, consumers, payers, and investors would know whether or not the genetic test or other laboratory-developed test performed as claimed,” Cossman said.
USDS in some cases will also look at clinical utility of diagnostic tests.
USDS assessments could also potentially clear up some of the confusion in the industry over FDA’s regulation of certain algorithm-based laboratory-developed tests, so called in vitro diagnostic multivariate index assays.
“It is hoped that USDS will be able to help clear up confusion with IVDMIA and lab-developed tests by assisting in the evaluation of performance,” Cossman said.
A more comprehensive version of this article appears in today's issue of Pharmacogenomics Reporter.