Who Profits From President's Initiative on Rapid HIV Tests?

In his state of the union address on Tuesday night, President Bush proposed a Federal initiative “to join with African-American churches and faith-based groups to deliver rapid HIV tests to millions.”

We took a quick look at the text of the President's annual speech, which sets the administration's policy tone for the next year, to see what it might mean to what we call the New Biology Economy.

The first thing we thought of is this: What companies might prosper from such a government push on rapid HIV tests?

According to Rapid-Diagnostics.org, a website funded by the US Agency for International Development and PATH, a Seattle-based non-profit group, there are some 30 commercially available rapid diagnostic tests for HIV from companies like Abbott Diagnostics, the largest supplier of HIV tests, and Bio-Rad Laboratories.

Rapid HIV tests are critically important as they are cheaper, and produce results in 5 to 30 minutes, which stands to increase the number of patients who actually get their results instead of the significant number of people who make the initial visit for counseling and a blood-draw for a test, but never return for results that may take from one to two weeks to obtain in traditional EIA (enzyme immunoassay) testing proceedure.

In 2004, the FDA approved Bio-Rad's Multispot HIV-1/HIV-2 Rapid Test for use by clinical laboratories and OraSure Technologies Advance HIV1/2 Antibody Test for use with oral fluid and for use on plasma specimens, the only rapid HIV test to be approved in the US by the FDA for use with oral fluid, according to the CDC.

According to the 2005 HIV Testing Conference website, the rollout of rapid HIV testing in the United States “in public-health settings has varied considerably by state and local health department due to both state regulatory requirements and system-development needs. State regulations that require phlebotomy training for personnel performing finger-stick rapid-tests (California) or that CLIA-waived laboratories have lab directors with a PhD (Pennsylvania) were barriers for implementing CLIA-waived rapid tests in community-based organizations.”

The organization concludes that the “roll-out of rapid testing in the United States has taken time.”

Recently, the Los Angeles Gay & Lesbian Center and two of 14 San Francisco Department of Health testing sites stopped using the OraQuick Advance test. The LA organization reported 13 false positives in November, which certainly is devastating news for a patient to receive.

OraSure Technologies Inc., the Bethlehem, Pa.-based company that makes the OraQuick Advance tests, stands behind its product and is working with testing sites, the CDC and the FDA to try to discover why the false positives are occurring in what appear to be geographical clusters.

Why has the rollout of a rapid HIV tests in the US been slower than overseas, where these tests are much more available?

According to the website, the Body, it is because these diagnostics test for both HIV-1,the most common HIV infection in the world, and HIV-2, which is most prevalent in West Africa.

The patent for the HIV-1 test is controlled by the US National Institutes of Health (NIH) while Bio-Rad controls the HIV-2 patent, which was originally granted to France's Institut Pasteur and was then licensed to a spin-off, for-profit corporation. After a series of business transactions, effective control of the US patent was subsequently traded among the big-three makers of conventional diagnostics, including Abbott Laboratories, the largest supplier of HIV tests. The result: anyone who wants to market an HIV test that detects both HIV-1 and HIV-2 in the U.S. needs the permission of Abbott and the others, according to a 2002 article available online.

So, as it typical of any biomedical initiative, there are patents and licenses and royalties to pay, and operational issues to overcome before a person can go to a church or other organization and get routed to a rapid HIV test. This will be an interesting process to observe.