The Food and Drug Administration (FDA) has green-lighted a test that can quickly determine whether a person is infected with deadly avian flu.
The FDA yesterday approved the AVantage A/H5N1 Flu Test, made by Sunnyvale, Calif.-based Arbor Vita Corp. The nose or throat swab can detect the infection in less than 40 minutes, the agency said; previous diagnostic tests took up to four hours.
"This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu."
H5N1 is rare in humans, but can be deadly when it strikes, killing around 60 percent of victims. Since 2003, a reported 417 people, mostly in Asia and the Middle East, have contracted the virus, and 257 of them died, according to the World Health Organization (WHO). Public health officials fear a flu pandemic could occur if H5N1 mutates in a way that allows it to more easily infect humans. The antiviral drug Tamiflu may treat the virus, but the medicine could be rendered useless if H5N1 combines with flu strains resistant to the drug, as are nearly all currently circulating in the U.S.
The test hasn’t been cleared in other countries, but Arbor Vita spokesperson Debra Bannister says the company expects other nations to follow suit. Bannister said no price has been set yet for the test, which will likely come to the market in the fall.
Updated at 3:28 p.m. April 8 to correct that no price has been set for the test, not a drug.
Colorized transmission electron micrograph of avian influenza A H5N1 viruses (in gold)/CDC, Cynthia Goldsmith via Wikimedia Commons