CDRH Releases Proposed Guidance Development for FY 2013
FDA's Center for Devices and Radiological Health (CDRH) has released its list of priorities for developing guidance documents for 2013. These priorities include medical device guidance documents that the agency fully intends to publish within a year (the A-list), and guidance documents FDA will publish within the year as resources permit (the B-list). Guidance documents prioritized to the A-list include: In Vitro Companion Diagnostic Devices; Mobile Medical Applications; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; and De Novo Classification Process (Evaluation of Automatic Class III Designation). Among the B-list items, CDRH included Direct to Consumer Genetic Testing: IVDs. Neither the A nor B list mention the long-awaited guidance document for lab-developed tests (LDTs). In July 2010, FDA announced it planned to require all LDTs to undergo regulatory review. The complete lists are available online.
Nanosphere Screen for CYP2C19 Mutations Receives FDA Nod
FDA has cleared Nanosphere's CYP2C19 Nucleic Acid Test on the Verigene System. The test identifies variants in the gene for the cytochrome P450 2C19 (CYP2C19) enzyme that metabolizes approximately 15% of all prescribed drugs. Two variants in the CYP2C19 gene, *2 and *3, lead to reduced drug metabolism, while the *17 variant causes increased drug metabolism. Using whole-blood samples, the Verigene CYP2C19 Test detects the presence of these mutations in less than 2.5 hours, providing clinicians with essential guidance for treating patients with drugs metabolized by this pathway.