FDA Grants Emergency Use to Arbor Vita’s Influenza A Assay

June 20, 2014

U.S. government and foreign laboratories may now use Arbor Vita’s A/H7N9 Influenza Rapid Test to confirm or rule out infection with the H7N9 strain of influenza A in patients showing signs of respiratory illness.

The emergency use authorization, granted April 25 and posted online Monday, requires Arbor Vita to distribute the rapid test fact sheets for healthcare professionals and patients to laboratories and online, ensure that laboratories using the test at home and abroad have an adequate means of reporting test results to healthcare workers and federal and state authorities, track and report adverse events and false positive and negative results and keep records of device usage.

The company must also make clear in its labeling and marketing tools that the test is not currently FDA-approved.

The FDA’s Emergency Use program allows the commissioner to grant use of an unapproved medical device or unapproved use of an approved medical device “during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security.”

Arbor Vita applied for emergency use of its A/H7N9 test on April 9, claiming that rapid, simple, and affordable detection of the virus could serve as a critical juncture in halting the virus’ spread.

A/H7N9 was first reported in humans in China in March 2013. Most cases have resulted in severe respiratory illness, according to the Centers for Disease Control and Prevention, and a third of the victims have died. — Lena Freund

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