Home HIV Test Kit May Soon Be on Market : Health: State officials say a Costa Mesa firm has a good chance of satisfying their concerns about reliability and procedures for notifying patients of results.
When Health Test Inc. began offering a home HIV test in March, the timing seemed right. The test, which people could order by mail for use in privacy, hit the market just after professional basketball player Magic Johnson announced he was HIV-positive.
A public newly concerned about AIDS responded to the company’s television commercial in such numbers that Health Test President Stephen Coonan foresaw sales, at $24.95 a test, to more than 100,000 people each year in California alone.
But the company’s instant success was short-lived. Five days after the commercials began running, the state ordered the operation shut down and the advertising stopped until Health Test could provide more data on the product.
Coonan, who for two months has been putting together information to satisfy the state, now says he will have the task completed this week.
James Barquest, chief of the medical devices unit of the California Department of Health Services, said the state has two concerns: whether the consumer might adversely affect the results by performing the test incorrectly; and how the consumer would learn the results.
If Coonan succeeds--and state health authorities say that his chances are good--he will be the first to market an in-home test for the virus that causes AIDS. Other companies have tried, but they have become mired in challenges from health authorities and AIDS-patient advocates.
AIDS clinic officials have criticized at-home testing for the virus. They see the testing visit as a chance to warn patients against risky behavior. But as it becomes clear that people in non-risk groups like Johnson can contract HIV, that argument is losing its power.
“A lot of opposition to this kind of testing has diffused over the past four years,” which was the last time such a home test came before health authorities, Barquest said. “There’s been a recognition on the part of the health care community that the availability of testing is a good thing.”
He said his department will be able to rule on Coonan’s home test within two weeks if the information is complete.
To administer the test, a person holds to a fingertip a device that looks like a pen. When a button on the pen is pushed, a needle pricks the finger. The person uses filter paper to blot several drops of blood. The sample is then mailed to the company. It is identified either by the person’s name or by a code number that is intended to ensure privacy.
The company’s initial proposal was that negative results would be mailed to the customer within a week, along with a wallet-size card certifying the person as HIV-negative. Instructions on the back of the card would emphasize the importance of regular testing.
With a positive result, Coonan had intended to have a qualified counselor telephone the customer and recommend a confirmatory test.
Now, the state says, it will require Coonan’s company to do the confirmatory test before it releases any positive results. The expense of doing so, Coonan said, might eliminate the profit from his venture. If that happens, he said, he would try to recoup his investment, then possibly set up the company as a nonprofit entity.
Coonan raised the start-up money for Health Test, which employs four people, from investors and by selling a company he founded, Aviation Medical Systems. The company provided drug testing services to the Federal Aviation Administration.
Coonan believes that through Health Test he is doing a good thing.
“I looked at trying to put some value into what I do for a living,” he said. “What I can contribute is testing. All the (AIDS) research in the world will not amount to a hill of beans until people get tested.”
Another state official, Anna Ramirez, said the test could prove very popular. Ramirez is chief of the Preventive Services Section of the state Office of AIDS.
“A lot of people would like to be tested, and they would rather do it in privacy,” she said, noting that state clinics tested 272,964 people in 1991, up 36% from the year earlier.
Coonan cited estimates that fewer than one in 10 people who is HIV-positive knows it.
With the goal of encouraging testing, Health Test in its March commercial portrayed a man and woman alluding to their concern for their loved ones and the dangers of the modern world. The couple in the commercial, which ran for five days, were white, healthy-looking and placed amid comfortable furnishings.
The final frame flashed an 800 number for Health Test Inc. and showed pictures of the credit cards that the consumer could use to place an order. The format was similar to that used in late-night advertising for kitchen gizmos.
“We’re trying to reach middle America,” Coonan said.
