AEGiS-ATN: Improved Viral Load Test: Open Letter on FDA Approval

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

Improved Viral Load Test: Open Letter on FDA Approval

AIDS TREATMENT NEWS Issue #303, September 18, 1998
John S. James

A community consensus letter to the FDA is asking the Agency to move quickly on the application for approval of the UltraSensitive HIV viral load test, developed by Roche Molecular Systems. The UltraSensitive test uses a small modification to the standard viral load test which is already approved, to get reliable data as low as 50 copies, instead of the current 400-copy limit. Many doctors are already using the new version, because a value below 50 is a better indication that control of the virus can be maintained with the patient's current drug regimen. But there are often serious difficulties in getting the new test paid for, especially by public programs like Medicaid and Medicare, because it is not officially approved. Much work is now being done to allow access in major public hospitals in the New York City area. But the problem is national.

The consensus letter has already been signed by treatment experts at ACT UP/Golden Gate, ACT UP/New York, AIDS Project Los Angeles, Gay Men's Health Crisis, National AIDS Treatment Advocacy Project, National Minority AIDS Council, San Francisco AIDS Foundation, Seattle Treatment Education Project (STEP), Test Positive Aware Network, and other organizations.

To get a copy of the letter, find out how to sign on, or find out how to contact the FDA directly about this issue, check the Web site of the National AIDS Treatment Advocacy Project, http://www.natap.org.

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