Draft Guidelines Address ‘Home-Brew Testing’
FDA on Tuesday released draft guidelines for the regulation of one category of complex diagnostic tests called "multivariate index assays," the New York Times reports.
FDA currently regulates diagnostic tests sold to laboratories, hospitals and physicians. However, FDA does not regulate diagnostic tests developed and performed by single labs, also known as "home-brew tests." Multivariate index assays, one category of home-brew tests, measure multiple genes, proteins and other clinical information and analyze the data with algorithms or software programs.
According to FDA, multivariate index assays require regulation because the algorithms often are proprietary, and, as a result, physicians cannot interpret the results themselves (Pollack, New York Times, 9/6). In addition, according to FDA, the tests require regulation to reduce the risk that they could lead to incorrect diagnoses for serious conditions such as breast and ovarian cancers.
FDA said that most of the tests will require some level of review before they enter the market and that some will require full regulatory approval, with the level of review determined by a "risk-based approach" (Wilde Mathews, Wall Street Journal, 9/6). The draft guidelines remain open for public comment (New York Times, 9/6).