FDA Grants ViraCor EUA for H1N1 Test, Warns Millipore Over Flu Test Marketing

By Kirell Lakhman

FDA has given an emergency-use authorization to ViraCor for its 2009 H1N1 influenza A real-time PCR test, and warned Millipore over its marketing campaign for its flu diagnostics, according to the agency.

FDA granted the authorization in a letter to ViraCor dated Jan. 21. The letter was made available ion the agency's web site yesterday.

"The scope of this authorization is limited to ViraCor Laboratories' use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection," the letter states.

Also yesterday, FDA published a letter it sent to Millipore warning the company over promotional materials for influenza diagnostics products. In the letter, dated Sep. 29, 2009, the agency "cited a promotional e-mail for Millipore's Light Diagnostics brand of respiratory screens and panels and its SimulFluor Flu A/B typing kit," according to a report in GenomeWeb Daily News.

According to the letter, "[t]he FDA has determined that your firm offers products for sale that are intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people. These products have not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus."

The FDA requested that Millipore immediately cease marketing any unapproved or uncleared products for the H1N1flu virus.

Millipore officials were unable to reply to a request for comment before this article was published, according to GenomeWeb Daily News.