AEGiS-Reuters: Home AIDS virus test to be available in United States

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Home AIDS virus test to be available in United States

Reuters NewMedia, Inc. - 30 July 1996


CHICAGO (Reuter) - An anonymous home test for the virus that causes AIDS that will be available immediately nationwide has been approved for marketing by the Food and Drug Administration, the developing company said.

"Anyone who is unwilling or unable to go to a clinic or go to the doctor now has an alternative available to them," Home Access Health Corp. President Richard Quattrocchi said in a telephone interview on Wednesday.

"They can now get into treatment and protect themselves and their loved ones," he said.

The test for the virus will be available by calling a toll-free number and Home Access plans to start shipping to major drug store chains in August, Quattrocchi said. An advertising campaign is to start next month.

The test is completely anonymous because the user draws his own blood at home and retrieves the results by telephone using an identification number.

The start-up company based in the Chicago suburb of Hoffman Estates is competing against pharmaceutical giant Johnson & Johnson, which has begun offering a similar test kit in a handful of states.

The idea of a home test for the virus has drawn criticism from some medical experts because of what they called an inherent lack of support when a test is done alone at home.

But Quattrocchi said Home Access has counsellors with degrees in social work and other training who are ready to speak to clients 24 hours a day. Anyone who tests positive will hear the news from one of those counsellors, he said.

To use the kit, the user must call a toll-free telephone number to register. With a lancet provided, the user pricks a finger and drops blood on a prepared card, which is mailed in special packaging to the Home Access laboratory. The user can then call another number for results.

In clinical trials conducted in late 1994 and early 1995, the company said the test's accuracy rate was 99.9 percent.

"Home Access has gone through extensive clinical trials on this, and we have proven to our satisfaction and the U.S. Food and Drug Administration's satisfaction that this system is safe," Quattrocchi said.

An FDA spokeswoman confirmed the agency had approved the test.

Home Access said its research shows more than 30 million Americans would buy such a test.

Quattrocchi, 37, said his company, founded in December 1992, can compete with Johnson & Johnson because it specialises in "telemedicine," where tests are done at home and results are retrieved via telephone.

The company is also working on home test kits for other diseases, including cancer.

The test sells for $49.95 for results in three business days or $39.95 for results in a week. The toll-free number to order a test is 800 HIV-TEST (800 448-8378).
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