Yet another HIV test FDA-approved: March 24, 2004 25 March 2004
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Brian T Foley,
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Los Alamos National Lab, Los Alamos, NM 87545

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Re: Yet another HIV test FDA-approved: March 24, 2004

http://www.pennlive.com/business/expres stimes/index.ssf?/base/business-1/1080124570283470.xml

OraSure's HIV test gets FDA backing

Bethlehem company's quick test can detect antibodies in two major strains of the virus.

Wednesday, March 24, 2004

By ANTHONY SALAMONE The Express-Times

BETHLEHEM -- OraSure Technologies Inc. has received government approval on a rapid blood test that can detect antibodies in both major strains of HIV virus that cause AIDS.

The Bethlehem-based diagnostics company said its test, called OraQuick Rapid HIV-1/2, detects the presence of HIV-2 antibodies.

The company already makes and sells OraQuick, which detects HIV-1 antibodies.

The OraQuick Rapid HIV-1/2 is the only rapid test approved by the FDA to detect both viruses, the company said.

President Mike Gausling said in a statement the FDA approval is another "significant milestone" for OraSure.

"It certainly allows us, from a competitive standpoint, to differentiate ourselves from other rapid tests " added Ronald H. Spair, the company's chief financial officer.

The FDA approved the combination test for use with finger-stick and vein-puncture blood testing. An agency spokeswoman confirmed OraSure has received government approval.

OraSure hopes to obtain a license to certain HIV-2 patents that are held by Bio-Rad Laboratories Inc. of Hercules, Calif. Spair said the companies have reached an agreement in principle; details were not made available.

Bio-Rad makes and distributes research and clinical diagnostic products.

Offering a single rapid test for detecting antibodies to both HIV-1 and HIV-2 will allow for broader detection, treatment and prevention of HIV/AIDS, according to Spair.

HIV-1 and 2 are different strains of the virus that has affected an estimated 40 million people, though HIV-1 is more widespread, according to OraSure. The FDA first granted approval to OraQuick on Nov. 7, 2002.

Shares of OraSure rose 28 cents, or 4 percent, to close at $8.08 in Nasdaq trading Tuesday. Anthony Salamone can be reached at 610-258-7171 or by e-mail at tsalamone@express-times.com.

Competing interests: None declared