Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - June 4, 1996
Laurie McGinley, Staff Reporter of The Wall Street Journal
The test, called the Amplicor HIV-1 Monitor Test, will be manufactured by Roche Diagnostic Systems, a unit of Switzerland's Roche Holding Ltd.
"If the amount [of virus in the blood] is high, the data by Roche would suggest that you have a much higher chance of progressing to an AIDS-defining or other HIV-related disease," said Curtis Scribner, deputy director of the FDA's Office of Blood Research and Review.
Though the test was approved to track disease progression, it almost certainly will be used by many physicians to monitor how new antiviral drugs, called protease inhibitors, are working.
"It's a very big deal," said Brenda Lein, a spokeswoman for Project Inform, a large AIDS service organization in San Francisco. "Looking at viral load is at least as important as looking at other measures" that indicate the condition of the immune system.
David Barr, director of treatment education and advocacy at Gay Men's Health Crisis, an AIDS group in New York, also applauded the approval but said he wished that the agency had also approved it for use in disease management -- that is, in charting a person's response to the new antiviral drugs.
Without that approval, Mr. Barr said, insurance companies might not pay for the repeated testing needed to monitor whether a particular drug is helping an HIV-infected person.
But the FDA's Dr. Scribner said that there wasn't enough data to approve the test for measuring the effects of the new drugs, though the agency stands ready to expand the approved uses as more information becomes available.
The test works by amplifying genetic material from HIV-1, the virus that causes most AIDS cases in the U.S., and tagging it with colored indicators so that the material can be measured precisely.
Meanwhile, the agency cleared the first test that uses an oral sample, rather than blood, to confirm if a person has been infected with HIV. The test, called OraSure, was developed by Epitope Inc. of Beaverton, Ore., and will be marketed by SmithKline Beecham Consumer Healthcare, a division of Britain's SmithKline Beecham PLC. The test will be sold only to health-care providers.
In composite trading yesterday on the American Stock Exchange, Epitope closed at $21.50, up $1, or 4.9%. DE HIV; PROTEASE; IMMUNE SYSTEM; GAY; AIDS CASE
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