OraSure Technologies is first (with the exception of an outdated, complicated test sold by Abbott) to get coveted FDA approval for a rapid HIV diagnostic test, and it also won a hard-to-get CLIA waiver for the test after a one-day review by the Department of Health and Human Services; the waiver enables the test to be used in a much wider variety of non-laboratory settings. The company's opportunity looks huge, but the test's success is far from a sure bet.