July 16, 2012
FDA Approves Home Test for HIV
The FDA has approved a rapid, in-home test for Human Immunodeficiency Virus (HIV), the virus that causes AIDS. This is an approval of the premarket approval application (PMA) by the FDA's Center for Biologics Evaluation and Research, which oversees the review of devices that involve the use of a biologic reagent. This is the first in-home test for HIV infection that produces immediate results, and will be sold over the counter (OTC) by pharmacies. The single-use test, OraQuick, detects antibodies to viral strains HIV-1 and HIV-2, and allows an individual to take an oral swab (no blood required) and receive results at home in 20-40 minutes. The package insert instructs users that this test be a predicate to confirmation by a physician. This is the first at-home test for an infectious disease, and the need (and potential market) for such a test is supported by HIV statistics from the CDC, which suggest that at least 20% of those infected with HIV are unaware of their status. Several developments in the last several decades suggest that this test might be useful to some who suspect possible HIV infection – decreased stigma over HIV-positive status, coupled with the availability of more effective antiviral treatments. However, the cost of the test will be over $17.50 (current price to clinics), which will be pricey for many, and, furthermore, to note that antiviral regimens for HIV have improved over time does not mean that access to treatment is universal. The test is only approved for sale to those 17 and older, and pharmacies may screen for verified age in selling the product. There are other FDA-approved HIV home tests available, but they require sending a sample to a laboratory. While this test expands options for those at risk of HIV infection, it is a relatively straightforward application of long-existing technologies; the FDA resisted the approval of other HIV home test applications for years. The CDC estimates that approximately 50,000 people are newly infected with HIV each year in the United States. Although some of the stigma associated with HIV has decreased, there is still a visible effort to encourage testing for high-risk groups (or those engaged in high-risk behaviors); National HIV Testing Day was just observed on June 27 of this year.
Labels: CDC, FDA, Medical Devices
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