August 2009 Clinical Laboratory News: News from the FDA

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August 2009: Volume 35, Number 8

 Osmetech’s Cystic Fibrosis Genotyping Test Cleared

Osmetech announced that it has received 510(k) clearance from FDA for its eSensor Cystic Fibrosis Genotyping Test for use on the eSensor XT-8 System. This multiplex test is used to screen adults of reproductive age and newborns for carrier status, as well as confirm cystic fibrosis diagnosis in newborns and children. This is Osmetech’s second multiplex test to receive 510(k) clearance for the eSensor XT-8 System, following clearance of the Warfarin Sensitivity Test.

FDA Transparency Blog Launched

In June, FDA posted its first entry to the FDA Transparency Blog, a new effort aimed at making FDA more open. The stated purpose of the blog is to “discuss various ways in which the FDA could provide information to the public about what FDA is doing, the bases for FDA’s decisions, and the processes used to make agency decisions.” The blog will be maintained by the FDA’s Transparency Task Force, which was created by newly appointed FDA commissioner Margaret Hamburg, MD, and chaired by principal deputy commissioner Joshua Sharfstein, MD. The blog is available online.

FDA Wants More Data on Orasure’s HCV Test

Orasure announced an update on the status of its application for FDA approval of the OraQuick Hepatitis (HCV) test, stating that additional trial data will be required for approval. Orasure originally filed a premarket approval application with FDA in the fourth quarter of 2008, seeking approval for the use of the product with multiple specimen types, including venous whole blood, fingerstick whole blood, oral fluid, and other sample types. In its review, FDA indicated that Orasure’s clinical data could have been affected by bias because the same operators performed the test and interpreted the results on multiple specimen types taken from the same patients. FDA concluded that additional clinical testing will be required to obtain approval for the venous whole blood claim, and a new clinical study will be required for approval of claims for oral fluids and other sample types. Although Orasure believes that the clinical data originally submitted is sufficient to support approval, and that the company complied with the clinical trial protocol that was approved by FDA, Orasure has agreed to conduct additional testing.

Cepheid Receives FDA Clearance for C. difficile Test

Cepheid received FDA clearance to market its Xpert C. difficile test, a molecular diagnostic test designed to detect the bacterium Clostridium difficile within 45 minutes. C. difficile is a common, spore-forming bacterium responsible for thousands of healthcare-associated infections. The test targets the Toxin B (tcdB) gene, a critical component of all toxigenic C. difficile strains including the 027/NAP1/BI epidemic strain. Cepheid said that it will work closely with FDA to develop an additional test offering simultaneous differentiation of the 027/NAP1/BI strain. The Xpert C. difficile test is Cepheid’s seventh test to receive FDA clearance, and the fourth in its menu of healthcare-associated infections products. The test runs on Cepheid’s GeneXpert System.

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