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Longhorn Gets FDA Emergency Use Authorization for H1N1 Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Longhorn Vaccines & Diagnostics has received Emergency Use Authorization from the US Food and Drug Administration for its Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay in CLIA high-complexity laboratories.

The test has been authorized for use on Life Technologies' ABI 7500 system, the San Antonio-based firm said in a statement yesterday. It noted that the assay includes PrimeStore MTM, a clinical collection and transport product that preserves the released nucleic acids and contains an internal RNA control capable of tracking degradation of the sample from the point of collection.

"An infectious disease physician and a molecular biologist designed the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay to generate rapid, high-quality PCR results, in as little as two hours while improving safety and reducing laboratory preparation time," Longhorn Vaccines & Diagnostics CEO Gerald Fischer said.

The firm expects to submit a separate 510(k) application with the FDA for clearance of the assay.

The FDA also has granted an EUA for Diagnostic Hybrids' monoclonal antibody fluorescent staining kit for identification of 2009 H1N1 influenza A in direct patient specimens or incubated tissue cultures, the firm's parent, Quidel, said today.

These tests are the latest of several to gain EUAs from the FDA over the past 10 months for identifying H1N1.

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