Chicago Tribune (CT) - FRIDAY, June 2, 1995 Edition: NORTH SPORTS FINAL Section: BUSINESS Page: 3 Word Count: 513
Marianne Taylor, Tribune Staff Writer.

In doing so, Home Access Health Corp. could be elbowing for shelf space in the nation's pharmacies with medical-product powerhouses, including Johnson & Johnson, whose unit, Direct Access Diagnostics, also has filed for Food and Drug Administration approval for a home HIV test.

ChemTrak Inc., of Sunnyvale, Calif., which manufactures a variety of medical home-test kits, too, has filed for approval for its version of the kit.

All three companies have filed for final approval from the FDA, after conducting clinical trials with their kits.

Home-test kits for conditions such as pregnancy, diabetes and cholesterol levels have become popular in recent years, but the idea that someone could test at home for HIV, the virus that causes AIDS (acquired immune deficiency syndrome) has been controversial.

Until February, the FDA had effectively held that HIV testing should be confined to a professional setting, where counselors would be available to discuss HIV-positive findings. Another concern has been how to minimize "false positive" results, or the possibility of test errors.

But under pressure from activists and others, including former surgeon general C. Everett Koop, the FDA in February said it would allow home tests for HIV under certain guidelines. Home testing would increase the numbers of those seeking to be tested for HIV, according to Koop and others.

Tracey Powell, chief executive of Home Access, said that his company's market research shows that as many as 30 million people would be interested in buying a home-test kit for HIV, a $600 million market.

"Home collection is affordable and accessible," he said. More than half the Americans who would like to be tested for the HIV virus haven't been tested, partly because they fear being discriminated against for simply taking the test, Powell said, citing his company's market research. A home-test kit promises anonymity, he said.

Home Access proposes to market a kit that will cost less than $50 and offer results in as little as three days.

The kits before the FDA for approval are not actually home tests, but home-collection devices.

To use the proposed Home Access kit, for instance, an individual would prick his finger, rub the blood sample on a card provided in the kit, and mail it to the company's lab in a special envelope designed to protect it from heat and humidity, said Richard A. Quattrocchi, president of Home Access.

Lab technicians would test for false positives and do another confirmation test on HIV-positive samples, Quattrocchi said. An individual would get test results by calling an 800 number, and identifying himself by code number, not name.

Powell said his company would offer counseling as an integral part of its test kit.

Counselors are available, by phone, to anyone who calls before starting the test, Powell said. And when someone calls for results, an automated telephone program would switch anyone with HIV-positive results to a trained counselor, he added.

950602
CT950601

ÆGIS is made possible through unrestricted grants from Boehringer Ingelheim, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1995. This material is designed to support, not replace, the relationship that exists between you and your doctor.

Copyright ©1980, 2003. AEGiS. All materials appearing on ÆGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of ÆGiS, or the party credited as the provider of the content.