OraSure Says CDC Has Placed an Order for Its Oral HIV Test
Posted on: Thursday, 18 May 2006, 15:06 CDT
By Linda Loyd, The Philadelphia Inquirer
May 18--OraSure Technologies Inc., maker of a 20-minute HIV diagnostic test, said today the Centers for Disease Control and Prevention has placed a $2.3 million bulk order for its rapid oral HIV test.
The Bethehem company increased 2006 financial guidance and now projects revenues of $80 million and earnings of 10 cents to 12 cents per share for the year.
OraSure said the latest order, the CDC's fourth bulk purchase since 2003, was in response to a growing demand among U.S. public health groups for an oral test, which uses saliva to diagnose HIV, the virus that causes AIDS. The company said the demand for tests is "well in excess of the quantity covered by the CDC's latest bulk purchase."
OraSure said it is in discussions with federal agencies about additional purchases this year and with several cities that want to increase oral rapid HIV testing.
OraSure said its test can detect with more than 99 percent accuracy whether a person has HIV-1 or HIV-2, using a swab to collect cells in saliva in the mouth. The swab is placed in a vial of testing fluid, and 20 minutes later the result is known. The test can also screen HIV in blood.
The company is talking with U.S. regulators about selling a home-use HIV test that would be available over the counter like a home pregnancy test. The Food and Drug Administration has discussed home HIV tests for years, but has been reluctant to approve them, citing concerns that people might misinterpret the results or react badly -- or even become suicidal -- to news that they are HIV-positive.
But, the FDA said the benefits of a home test included more people knowing their HIV status, and earlier diagnosis of HIV infection and therefore earlier intervention.
More than one million people have HIV in the United States, according to the CDC, and roughly 25 percent do not know they are infected. About 40,000 new HIV infections occur each year.
OraSure shares were up 4 cents, or 0.43 percent, at $9.38 in late morning trading on the Nasdaq.
Contact staff writer Linda Loyd at 215-854-2831 or lloyd@phillynews.com.
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Source: The Philadelphia Inquirer
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