FDA Releases Draft Guidance on Screening Donors for West Nile Virus, Syphilis
The Food and Drug Administration (FDA) has announced the availability of the October 2013 draft documents, "Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis)."
The first document recommends that establishments that determine HCT/P donor eligibility (HCT/P establishments) use an FDA-licensed nucleic acid test to screen donors of HCT/Ps for West Nile Virus (WNV) infection. This guidance replaces an April 2008 draft guidance. When finalized, the testing recommendations in this guidance will also supplement the donor screening recommendations for WNV that were made in an August 2007 guidance and that will remain in place.
The second draft guidance document updates recommendations for HCT/P establishments when testing donors for Treponema pallidum (T. pallidum), the bacterium that causes syphilis. As required under federal regulations, HCT/P establishments must test donor specimens for T. pallidum using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance also clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for testing donors for T. pallidum infection under the criteria specified in federal regulations. When finalized, the recommendations in this guidance will supersede the recommendations for testing HCT/P donors for T. pallidum laid out in the August 2007 document, "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)."
The agency is accepting comments on both draft guidance documents until January 22 and February 3, 2014, respectively. Electronic comments may be submitted online.
Hologic's HPV Genotype Assay Approved by FDA for Panther System
FDA approved Hologic's Aptima HPV 16 18/45 genotype assay for use on the company's fully automated Panther system. The Aptima HPV 16 18/45 genotype assay is the first FDA-approved test for genotyping high-risk human papillomavirus (HPV) types 16, 18, and/or 45. Performed using Hologic's ThinPrep liquid cytology specimen, it is designed to test specimens from women with Aptima HPV assay positive results. Specifically, FDA approved the test for detecting the presence or absence of these three HPV types in HPV-positive patients 30 years and older, or in HPV patients 21 years and older with atypical squamous cells of undetermined significance. The Aptima HPV 16 18/45 genotype assay also last year received FDA approval on the Hologic high-throughput Tigris system.
FDA Clears IMDx C. difficile Test
IntelligentMDx has received FDA clearance for the IMDx C. difficile for Abbott m2000 assay, which detects the genes for toxins A and B produced by toxigenic strains of Clostridium difficile (C. difficile). Using human liquid or soft stool specimens, this assay can identify 31 different toxigenic C. difficile strains, including NAP1 and tcdB-variant strains such as 1470. The IMDx C. difficile for Abbott m2000 assay is part of a broad real-time PCR test menu designed, developed, and manufactured for use on Abbott's RealTime m2000 system under a multi-year distribution agreement with Abbott. This is the third test from IMDx to receive FDA clearance this year for use on Abbott's m2000 system and follows clearances of the IMDx VanR for Abbott m2000 and IMDx Flu A/B and RSV for Abbott m2000 assays.