FDA Clears HIV Home Test Sys Developed By J&J Unit
WASHINGTON (Dow Jones)--The Food and Drug Administration approved the first HIV test system that includes collection of blood sampled at home.
The test system, developed by Johnson & Johnson (JNJ) unit Direct Access Diagnostics, Bridegewater, Conn., will be available for over-the-counter purchase in Texas and sold through a toll-free number in Texas and Florida.
The new test system comprises three integrated components: an over-the-counter home blood collection kit, HIV-1 antibody testing at a certiifed lab, and a test result center that provides counseling and referral anonymously.
''We are confident that this new home system can provide accurate results while assuring patient anonymity and appropriate counseling,'' said FDA commissioner David Kessler. ''Science and technology have evolved to the point where we believe the benefits of this new product outweigh the risks.''
The FDA said technological advances in the accuracy of HIV antibody testing, the availability of treatments for people who are infected but do not yet have symptoms, and the public health benefits that would accrue from more people being aware of their HIV status all contribued to the agency's decision to approve the kit for home use.
The decision was consistent with advice the FDA received at a June 1994 meeting of its Blood Products Advisory Committee, when the committee concluded that the potential benefits of over-the-counter home specimen collection kits outweighed the potential risks.
The agency said the lab testing kit is consistent with FDA recommendations for blood and plasma establishements, whereby any initially reactive sample is retested twice and samples reactive in two out of three assays are further confirmed with a more specific test, such as the Western blot.
After purchasing a kit, a user begins the testing process by reading a pre-test counseling booklet about HIV and AIDS. Using enclosed lancets, the person takes a finger stick blood sample, which is placed on a designated area of a test card precoded with a unique indentification number.
The test card is mailed in a protective envelope to a certified laboratory for HIV-1 antibody testing. Once instructions are followed and an adequate sample has been sent, users can receive results seven days later by calling a toll-free number.
FDA's approval was based on data showing that each component of the test system, as well as the complete system itself, was safe and effective for its intended use. Clinical studies showed that the kit's test card was able to correctly identify negative samples 99.95% of the time on evaluations of over 3,940 samples. The test also correctly identified 100% of 150 known positive samples.
The HIV home collection and testing service, known as Confide, was developed in a collaboration of Chiron Corp. (CHIR) and Johnson & Johnson (JNJ) unit Direct Access Diagnostics.
Starting next month, the kits will only be available in Texas and Florida. Nationwide sales will be available in early 1997.
FDA officials say the company decided to limit the marketing of the kits, and as far as the agency is concerned it can be released nationwide whenever the company wants.
Jeffrey J. Leebaw, a spokesman for Johnson & Johnson, says Confide will be sold retail in Texas and via 1-800-THE-TEST. Residents of Florida will only be able to purchase the tests via the 800 telephone number. The test retails for $40 and will cost close to $50 through the 800 telephone number, officials said.
Texas and Florida were chosen as test markets due to the diverse but manageable population, Leebaw says.
The human immunodeficiency virus is the virus that causes AIDS and is the leading cause of death among people age 25 to 44 years in the U.S. Public health authorities say up to one million Americans are infected with HIV and as many as half of them don't know it. Officials say an
estimated 40,000 to 80,000 new infections occur each year.
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