ACLA responds to Genentech petition

The American Clinical Laboratory Association (ACLA) asked FDA to deny a Citizen's Petition in which Genentech (NYSE:DNA) asked the agency to regulate all laboratory-developed tests (LDTs) instead of CMS. In a response submitted to FDA last week, ACLA said the petition overstated the need for additional regulation of LDTs and overlooked the advantages of maintaining the current CLIA system under CMS, including a more rapid response to changes and improvements to tests than is possible under the FDA approval process. ACLA also said the petition's recommendations would stifle innovation and undermine the ability of laboratories to "bring the latest medical advances to patients expeditiously" (See BioCentury, Jan. 26, 2009). ...