Chicago Tribune (CT) - MONDAY, October 7, 1996 Edition: NORTH SPORTS FINAL Section: BUSINESS Page: 1 Word Count: 1,401
Chuck Hutchcraft, Tribune Staff Writer.

A year later, Quattrocchi switched insurance companies. This time someone came to his office and took a few drops of blood. Quattrocchi filed away the difference in his mental data bank.

Fast forward to this summer. The U.S. Food and Drug Administration approved two home AIDS tests--Johnson & Johnson's Confide, and Home Access, which is sold by Home Access Health Corp., a privately held, Hoffman Estates-based company of which Quattrocchi is president.

And these two tests may have competition. A different type of AIDS test, SmithKline Beecham's OraSure, is now available through doctors' offices and other medical facilities, and the company says it may be introduced later into the home-testing market.

(OraSure, which looks something like a toothbrush, draws antibodies from between the gum and cheek. Home Access and Confide, on the other hand, use blood samples. All of the tests determine if a person is infected with HIV, the virus that causes AIDS.)

Confide and Home Access are the latest entries into the home-diagnostics market, and arguably the most controversial. The idea of a home AIDS test, with results being provided over the phone, has split the public-health and AIDS communities, says Gordon Nary, executive director of the International Association of Physicians in AIDS Care in Chicago.

Nevertheless, the list of home diagnostics likely will continue to grow. Medical advances make it possible to find out more about the human body from ever-smaller amounts of body fluids with easy-to-use devices at the same time that consumers are taking more control over their own health care.

And what was once the purview of physicians and medical technicians, requiring costly equipment, can easily be done in the comfort and anonymity of one's own home with inexpensive kits.

Now it is possible to find on the shelf of your drugstore a variety of home tests and home diagnostics that will tell you whether you're pregnant, have high cholesterol levels or test positive for HIV.

"This is about as easy as it gets," said Alene Holzman, vice president of Sunnyvale, Calif.-based ChemTrak, as she demonstrated the company's Cholestrak kit, which is about the size of a granola bar. The demonstration took but a few minutes. In addition to the cholesterol test, ChemTrak developed an H.pylori test to diagnose ulcers, which is sold to physicians by Astar Merck, a pharmaceutical joint venture. And ChemTrak is seeking FDA approval of its own AIDS home test.

In the last 10 years, home diagnostics "has become its own category" in drugstores, says Gerry Hoeppner, spokesman for Eckerd Corp., a 1,727-store chain based in Clearwater, Fla., which sells both Home Access and Confide. The category now includes some 100 items, ranging from blood-pressure machines and other more sophisticated diagnostics to rubbing alcohol and rubber gloves.

The clinical diagnostics business in the United States totals about $25 billion, about 3 to 5 percent of total health-care expenditures. Diagnostics in physicians' offices and the home account for another $2 billion, according to Holzman.

While its share of health-care expenditures is relatively small, the home-diagnostics segment is certain to grow, if the past is any indicator. Sales of home pregnancy tests, for instance, soared 459 percent over a 12-year period, reaching $186 million by 1993 from $33 million in 1981.

Johnson & Johnson and Home Access decline to reveal figures from the first month or so of sales of their AIDS tests, although Quattrocchi does say sales of the Home Access product are exceeding expectations.

Home Access is available so far through Eckerd and the 2,800 stores of Rite Aid Corp. Both chains are primarily east of the Mississippi River, with Eckerd extending into Oklahoma and Texas. Quattrocchi says the rollout in the rest of the country is expected by the end of the year.

In addition to being available at Eckerd and Rite Aid, Confide is sold nationally in Wal-Mart Stores Inc., Kmart Corp. and Walgreen Co. stores, says Jeff Leebaw, spokesman for Johnson & Johnson.

Home diagnostics began with the scale, invented by the Egyptians. The thermometer arrived in the 1700s. The next device was quicker in coming, a glucose test to detect diabetes using urine, in 1941. The first home pregnancy test entered the market in 1977, followed by a glucose test using blood in 1980, an ovulation predictor and a test for colon cancer, both in 1985, and more recently the cholesterol and AIDS tests.

As the home-diagnostics list has expanded, so has consumer demand for them, for several reasons.

"Consumers are becoming more involved and more responsible for their wellness," said Eckerd's Hoeppner. This is reflected not only in sales of diagnostics but also of nutritional supplements, such as vitamins, and homeopathic treatments, and even in the kinds of questions consumers ask pharmacists about the medicines they are taking, Hoeppner said.

There also is the growing perception among consumers that they are being shortchanged by managed care, says ChemTrak's Holzman. At the same time, she says, home diagnostics nicely fits the trend in managed care of "transferring costs from the medical system . . . to the patient," Holzman said.

In any event, home diagnostics can only make for healthier consumers in the long run, say Holzman and her boss, Edward F. Covell, president and chief operating officer of ChemTrak.

"A lot of people don't make the annual physical, obviously. If you're (middle-aged) and prolonging the period (in between physicals), it would be a good idea to use the home test as an intermediate step to check those things that can be checked," Covell said.

And instead of evoking jealousy from doctors, home diagnostics are being welcomed, Holzman said. The glucose test, for instance, enables doctors and/or diabetics to monitor glucose levels and alter medication as needed, she said.

Finally, home diagnostics offer their users convenience and anonymity. This was the primary thinking behind the home AIDS test. But instead of being widely welcomed, alarms were sounded at first when the test that was to become Confide was proposed to the FDA in 1987.

Learning that one has AIDS can be more devastating even than discovering one might have colon cancer or is diabetic. Until recently, testing positive for HIV would have been a death sentence. New developments in AIDS treatment, however, hold forth the promise that the disease can be treated as a chronic condition, similar, say, to diabetes.

Still, many in the AIDS and health-care communities are concerned about the potentially dangerous reactions of someone learning over the phone that he or she is HIV-positive, and they are dubious about the phone counseling provided by Home Access and Confide.

Indeed, Dr. Allan Frank, a young internist who devoted a large part of his career to treating HIV-positive and AIDS patients, was skeptical when Quattrocchi first asked him to sign on as medical director at Home Access to develop such a counseling program. "You can't do counseling over the phone," was Frank's reaction. But he was eventually swayed.

Other attitudes are changing as well.

"Originally, I was against the idea," said Jubi Headley, publications editor for the department of health programs, the U.S. Conference of Mayors in Washington D.C., who works specifically with the organization's AIDS program. "To be honest with you, I do have concerns about (home testing and phone counseling) personally, (but) I cannot tell anybody in good conscience that getting results over the phone is harder than sitting in a clinic and getting results from someone you don't know."

The American Medical Association in 1989 adopted a policy opposing the use of AIDS home tests, but will likely reconsider that position when its House of Delegates meets in December, said Robert Rinaldi, the AMA's assistant vice president for science, technology and public policy.

The bottom line, says Headley, is that "people who would not get tested" otherwise may get tested at home.

CAPTION: PHOTO (color): Richard Quattrocchi (above), of Home Access Health Corp., says sales of its at-home AIDS test are exceeding expectations. Tribune photo by George Thompson. PHOTO (color): Dr. Allan Frank (below) is medical director of the firm, which offers phone counseling for those testing HIV-positive. Tribune photo by Jose More.

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