Pharmaceutical & Diagnostic Innovation

, Volume 4, Issue 2, pp 16–17 | Cite as

Diagnostic Developments

News & View

Test for avian influenza gets US FDA approval

The US FDA has approved a new laboratory test to diagnose H5 strains of influenza in patients suspected to be infected with the virus. The test was developed by the Centers for Disease Control and Prevention (CDC).[1] The product is called the Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set. The test provides preliminary results on suspected H5 influenza samples within 4 hours; previous testing technology would require at least 2–3 days to produce results. If the presence of the H5 strain is identified, then further testing is conducted to identify the specific H5 subtype (e.g. H5N1).

“This laboratory test is a major step forward in our ability to more quickly detect cases of H5 avian influenza and provides additional safeguards to protect public health,” commented HHS Secretary Mike Leavitt.[1]

The test will be distributed to Laboratory Response Network (LRN)-designated laboratories to enhance early detection and...


  1. 1.
    U.S. Department of Health & Human Services. FDA approves new laboratory test to detect human infections with avian influenza A/H5 viruses. Media release: 3 Feb 2006Google Scholar
  2. 2.
    GeneFluidics. UCLA/VA study demonstrates the rapid diagnosis of urinary tract infections with Genefluidics’ novel biosensor technology. Media release: 2 Feb 2006Google Scholar
  3. 3.
    University at Buffalo. Chemical sensors to sniff out diseases in human breath. Media release: 13 Feb 2006Google Scholar
  4. 4.
    Genzyme. Genzyme launches key test to monitor Gleevec® resistance. Media release: 9 Feb 2006Google Scholar
  5. 5.
    Laboratory Corporation of America. LabCorp now offering UGT1A1 pharmacogenetic test for dosing colorectal cancer therapy. Media release: 13 Feb 2006Google Scholar

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© Adis Data Information BV 2006

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