AEGiS-ATN: Viral Load: Roche Applies for Marketing Approval for UltraSensitive Test

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Viral Load: Roche Applies for Marketing Approval for UltraSensitive Test

AIDS TREATMENT NEWS Issue #300, August 7, 1998
John S. James

On June 26 Roche Molecular Systems, Inc. applied to the FDA for permission to market a more sensitive viral load test. The test that is commercially available today can reliably quantify viral load to as low as 400 copies per milliliter of plasma; the new method extends this limit of quantification to 50 copies. The new test, called the Amplicor HIV-1 Monitor(TM) UltraSensitive Method, is actually an optional specimen processing procedure used with the currently available test (the Amplicor HIV-1 Monitor).

At the recent Geneva conference, a widespread consensus emerged that physicians will want a test which measures below the current 400-copy limit; one reason is that patients who get to very low levels are likely to keep the virus suppressed for longer than those whose viral load is close to 400. However, in many cases it will be difficult to advise patients who have test results between 50 and 400, since there can be significant costs or drawbacks to changing antiretrovirals.

Many physicians are already using the more sensitive viral load tests; the Roche UltraSensitive method has been available to researchers in the U.S. since February 1997. Commercial approval will reduce problems of access to a test which is now widely agreed to be useful.

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