Cepheid gets special FDA OK for swine flu test

AP News
|
Posted: Jan 04, 2010 11:15 AM

Molecular diagnostics company Cepheid said Monday it received special Food and Drug Administration authorization to market a test that can detect swine flu in less than one hour.

The company said the FDA granted emergency use authorization to sell the Xpert Flu test, which can identify the 2009 strain of swine flu. The special authorization allows the test to be used in hospitals.

The test has not been approved by the FDA and is only authorized to be used until April 26 under the emergency use designation.

The World Health Organization has said that the swine flu outbreak has peaked in North America and some European countries. According to the agency, more than 11,500 people are known to have died from the disease since the outbreak began in April. Though the swine flu has been labeled a pandemic, it has so far been far less lethal than the seasonal flu, which kills between 250,000 and 500,000 people each year.

Shares of Cepheid rose 3 cents to $12.51 in morning trading.