Shares of OraSure Technologies Inc rose to their highest in more than 10 years after U.S. health regulators on Tuesday approved its in-home HIV test, the first such product to get the nod.

The company’s stock was up 12 percent at $13.57 on Thursday, making it one of the top percentage gainers on the Nasdaq.

More than 3.5 million OraSure shares changed hands by 1054 ET, several times its 10 day average daily volume of 0.34 million.

The approval makes OraQuick In-Home HIV Test the first over-the-counter self-administered examination for the virus.

The test provides results within 20 to 40 minutes from an oral fluid sample taken by swabbing the upper and lower gums inside the mouth.

ThinkEquity LLC analyst Spencer Nam expects the launch to have a major impact on the company’s fourth-quarter revenue and expects the stock to reach $17.00 by the year end.

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(Reuters)