Douglas Michels, the CEO of OraSure Technologies, has called his company's rapid at-home HIV test a “game-changer.”

Appearing on Fox Business, Michels said OraQuick, which won FDA approval earlier this month, would reach brick-and-mortar and virtual shelves by October 1. The cost, he added, has not been set yet, but it would be higher than the $17.50 health care professionals currently pay.

The OraQuick test detects the presence of the HIV virus by using a mouth swab.

“It's truly a game-changer, we believe,” Michels said. “Unfortunately today there's still 1.2 million people infected with HIV here in the United States. Up to 20 to 25 percent of those individuals are unaware of their infection. And it's that population – infected but unaware – that's responsible for 50 to 75 percent of the forward transmission.”

“So now we have a product that they can buy at retail. They can take home – test in the comfort and privacy of their home. And hopefully we can drive down incidents and help these people know their status and live a long and healthy life,” he added.