In parts of the world with high HIV prevalence and limited resources for prenatal care and testing, some have proposed offering nevirapine to every mother as she enters labor in order to prevent transmission from other to child at birth. But in areas with low rates of HIV incidence, knowing the HIV test result prior to delivery is essential to identify everyone who can be helped by treatment.

There are more than a dozen rapid HIV tests on the market worldwide and simple one-step tests are the norm in regions without expensive laboratory resources. But in a strange twist on the usual story, no easy-to-use rapid HIV tests have been approved by the FDA for use at point of care in US hospitals, clinics and testing centers. The single one-hour test that has been approved still depends on laboratory processing and expert interpretation.

Why are rapid HIV tests that are available in Japan, France and Thailand unobtainable in the United States? The answer seems to lie with big companies that make the conventional tests. Because of a web of patents and intellectual property agreements, these corporations have been keeping rapid testing out of the established $200 million per year US market for laboratory-based tests.

The problem stems not from testing for HIV-1, the most common HIV infection in the world, but with patents that cover testing for HIV-2, an AIDS-causing virus most prevalent in West Africa. Although HIV-2 infections have been reported in areas with large immigrant populations such as New York, overall, infections with the "other" HIV are rare in the United States. When a test for HIV-2 became available in 1990, the CDC recommended that HIV blood screening tests should be able to detect both types of HIV.

Although the FDA requires that blood-screening tests check for HIV-2, the agency does not ask the same of tests used to diagnose HIV in individuals. Yet producers of HIV diagnostic assays have voluntarily adopted the standards that an HIV test should be able to test for all forms of HIV prevalent in the world.

The patent for the HIV-1 test is controlled by the National Institutes of Health. The NIH has freely issued permission to use the patent in exchange for modest royalty payments that are shared with the French Institut Pasteur, a co-discoverer of HIV-1. Institut Pasteur, once it learned of HIV-2 and that the existing HIV test could not reliably detect it, received a comprehensive US patent for HIV-2, which was then licensed to a spin-off, for-profit corporation. The patent was subsequently traded among the big-three makers of conventional diagnostics. The result is that anyone who wants to market an HIV test that detects both HIV-1 and HIV-2 in the United States needs the permission of Abbott Laboratories and others.

Failure to come to terms over the HIV-2 patent has sunk many efforts to bring new rapid tests to market. Until recently OraQuick, which had been successfully used by the CDC on an experimental basis, seemed to be poised for FDA approval. When the company realized it would not be able to obtain a license to use the HIV-2 patent in the United States, it went to Abbott for distribution. The diagnostic giant would not agree to guarantee minimum yearly sales of the test. OraQuick executives feared that Abbott was only interested in obtaining the right to their product as a ploy to keep it off the market.

Reportedly, the CDC has asked the Justice Department to investigate the HIV-2 patent that passed to Bio-Rad laboratories with continuing encumbrances related to Abbott. And faced with the stalemate and clamor from the prevention community, the FDA last year gave a clear signal those diagnostic products that test for HIV-1 alone would receive a favorable review, given sufficient research outcomes. Reportedly, this has unlocked the gates and several rapid test makers have submitted applications. It's possible that an approval could be seen later this year.

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