Abbott, OraSure Form Deal on HIV Test

Overcoming some patent disputes, Abbott Laboratories Inc. and OraSure Technologies Inc. have agreed to jointly distribute a test that determines in 20 minutes whether someone has HIV. OraSure's quick test, using just a drop of blood from a pin prick, stands in contrast to a standard HIV laboratory test, which can take as long as two weeks for results. The lengthy wait has hurt public health efforts, as many people never return to the doctor to find out they are HIV-positive and may spread the disease.

The rapid tests were developed years ago and are widely available in other countries, but patent disputes have kept them out of the US market. Until two years ago, federal agencies had wanted any HIV diagnostic test to identify the presence of both the prevalent HIV-1 and much rarer HIV-2 strains. But small companies such as OraSure that make these tests have been unable to secure a key license from companies that share patent rights on HIV-2. Abbott, which holds a license on the HIV-2 patent, also has claimed patent rights on the design of some rapid tests, including OraSure's.

In the agreement to be announced today, Abbott has agreed to license to OraSure the patents related to the test design. The two companies are continuing negotiations involving the HIV-2 patents. The companies plan to bring to market a test awaiting final FDA approval for the more prevalent HIV-1 strain. The FDA told OraSure in May it is likely to approve the OraQuick test once certain questions are answered -- and the company expects to begin marketing in the United States later this year.

Under the terms of the deal, which is restricted to the United States, Abbott will market primarily to hospitals and physicians' office labs while OraSure will sell in the public health and criminal justice markets, where it already has a sales force. Abbott and OraSure hope to resolve the patent problem on HIV-2 and together market a test worldwide that detects both strains, executives for both companies say.

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