Saliva-based HIV test sold in Caribbean
Prior to seeking FDA approval next year, Beacon Diagnostics in San Diego is launching OraScreen HIV Rapid Test an HIV test that uses saliva instead of blood in the Caribbean.
"We decided to initially release the OraScreen test in a relatively small geographic area in order to control the launch and prepare our distributors for future worldwide distribution," says Jerome Mattingly, PhD, president of Beacon.
Beacon plans clinical trials of its test in the United States in early 1997, at which time it plans to seek FDA approval to market the test to professional health practitioners. Later in 1997, it will seek FDA approval for a mail-in version of the test for home use.
The test uses a simple multiple-step dipstick system that can be performed in 15 minutes without the need for technical training, instruments, or a laboratory, the company states.
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