American Association for Clinical Chemistry
Better health through laboratory medicine
March 2009 Clinical Laboratory News: News from the FDA

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March 2009: Volume 35, Number 3

  Genomics Advisor Created in Office of FDA’s Chief Scientist

FDA has created a new position in the Office of FDA’s Chief Scientist dedicated to improving the agency’s activities involving genomics and the analysis of complex DNA, protein, and small molecular expression patterns. The position was announced by acting FDA commissioner Frank Torti, who said that, “insights gained through genomics point a way to faster and more efficient evaluation of new medical therapies.” The new office will be led by Liz Mansfield, PhD, who has held high-level policy and scientific positions at FDA and in the private sector. As senior genomics advisor, Mansfield will focus on the FDA’s goal of providing the tools and personnel capable of analysis of complex genetic data.

 FDA Expands Use of Stool Test

FDA has cleared the use of a stool test developed by BD Diagnostics for the detection of Clostridium difficile infections. The test, known as the BD GeneOhm Cdiff molecular test, allows for the rapid detection of the toxin B gene found in virtually all toxigenic C. difficile strains. This is the only molecular assay for C. difficile with high sensitivity and specificity that is able to give definitive results within 2 hours. Results of the test may be able to eliminate multiple screenings, ultimately speeding up detection and avoiding unnecessary use of antibiotics.


Abbott’s Blood Analyzer Cartridges Receive FDA CLIA Waiver

Abbott announced that FDA has granted waived status under CLIA for five additional test cartridges used by its i-STAT handheld blood analyzer. Included in the waiver are: the E3+, EC4+, and 6+ cartridges used to assess metabolic state; the glucose cartridge used to assess blood glucose level; and the creatinine cartridge used to measure renal function. All five cartridges are components to the CHEM8+ cartridge, a basic chemistry panel that includes tests for hemoglobin and hematocrit levels, which received waived status in 2007. Waived status will allow these tests to be used beyond a hospital setting, including physician’s offices, outpatient clinics, and emergency departments.

FDA Publishes Guidance Document on Assay Migration Studies

FDA has released a new draft guidance document on the regulatory approach to gain FDA approval of certain licensed in vitro diagnostic devices when a previously approved or licensed assay is migrating to another system for which the assay has not been approved. The focus of this guidance is on design and performance criteria that should be fulfilled by a sponsor in order to use the migration study approach. The guidance document also describes information FDA recommends sponsors include in all premarket approval application supplements and biologics license applications. For more information, see the guidance document online.

AdvanDx E. coli Test Cleared

AdvanDx announced that FDA has granted 510(k) clearance for the company’s E. coli/P. aeruginosa PNA FISH test, the first FDA-cleared test for identifying the presence of the two bacteria in positive blood cultures. The test is intended to give early warning of bloodstream infections and takes only hours to produce results from cultures containing Gram-negative rods.

FDA Releases Early Communication About Ongoing Safety Review of Plavix

FDA has released an early communication concerning the safety review of clopidogrel, more commonly known as Plavix, amid concerns that the drug may be less effective in some patients than it is in others. Differences in how the drug is metabolized in each patient, compounded by the use of other drugs and genetics, may be responsible for the differences in effectiveness seen in some patients. The makers of Plavix, Sanofi-Aventis and Bristol-Myers Squibb, have agreed to work with FDA to conduct studies to obtain additional information that will allow FDA to better understand and characterize the effects of genetic factors and other drugs on the effectiveness of clopidogrel. The full communication is available online.