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Dx Firms Comply with FDA Instructions on Swine Flu Test Marketing

NEW YORK (GenomeWeb News) – All three firms cited by the US Food and Drug Administration last week for allegedly marketing tests for the 2009 H1N1 Flu Virus, also known as the swine flu, that had not been cleared for marketing by the agency have complied with FDA's instructions, they have confirmed for GenomeWeb Daily News.

The firms — Luminex, Becton Dickinson, and Prodesse — were reluctant to discuss future plans for the tests that were cited by FDA, but all of them confirmed that they had taken the actions specified by the agency in its warning letters issued last month. The products targeted by FDA included Luminex's xTAG Respiratory Viral Panel, the BD Directigen EZ Flu Test, and Prodesse's ProFlu+ Assay.

In an e-mail sent to GWDN on Friday, BD said that it took "the appropriate corrective actions to resolve" FDA's concerns.

"The BD EZ Flu A+B assay, like other rapid Flu A+B tests on the market, is cleared for detection of Influenza A and Influenza B nucleoprotein antigens which are highly conserved and present across known Influenza A and B viruses," the statement read. "It is not intended — and has not been evaluated by BD — for the identification and reporting of specific flu strains, including the 2009 variant of the H1N1 virus."

Likewise, Luminex said that it had taken "appropriate corrective action" on May 18, by removing specific references to H1N1 from the firm's website.

The Austin, Texas-based molecular diagnostics firm also said in a statement sent to GWDN today that its role in response to the H1N1 flu outbreak has "resulted in Luminex being identified as a manufacturer of influenza virus product lines that may be expected to be in short supply if the United States faces a disaster/ emergency."

It added that FDA's Office of In-Vitro Diagnostic Device Evaluation and Safety (OIVD) requested the firm's voluntary assistance in "planning for potential shortages of devices in order to have a list of resource names to assist in finding available product lines." Luminex said that it had agreed to help OIVD in the survey for the Emergency Shortages Database.

Prodesse had no comment on the FDA's warning letter, other than to say that it had complied with FDA's instructions.

However, Andy Shrago, Prodesse's chief marketing officer, told GWDN last week, "We've already talked with FDA about adding what will amount to a reactivity claim for swine flu, and we do intend to do that."

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