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FDA approves new
test that detects HIV before antibodies appear
FDA approves new
test that detects HIV before antibodies appear
U.S. health officials have approved a Gen-Probe Inc. test that can diagnose HIV sooner than other tests currently on the market, the Food and Drug Administration said on Thursday.
The test, called the Aptima HIV-1 RNA Qualitative Assay, helps detect genetic material to diagnose the HIV-1 virus before antibodies appear, the FDA said. It can also help confirm presence of the virus if antibodies are found.
Shares of the San Diego, Calif.-based company closed up 10 cents at $47.72 on Nasdaq after the approval.
The FDA said the Aptima test is as sensitive as other kinds of tests that measure the amount of virus in patients with established HIV infections.
On Wednesday, the FDA approved Gen-Probe's Procleix Ultrio test to screen donated blood, plasma, organs, and tissue for HIV-1 and hepatitis C virus. Ultrio was also cleared to detect the hepatitis B virus. (Reuters)
