OraSure emphasizes that its HIV home test is simply an additional option to the testing already available -- which often comes free -- at public health clinics, community service organizations and doctors' offices.
"We know that there's a lot of individuals who should be getting tested but aren't, and this is another opportunity for them to do so," OraSure's Ticho said. "Is it the right option for everyone? Probably not."
Nevertheless, with an HIV diagnosis no longer sounding a death knell, it could be a test whose time has come.
"The tide has really turned on HIV testing," said Dr. Rochelle Walensky, co-director of the Medical Practice Evaluation Center and an AIDS researcher at Massachusetts General Hospital in Boston.
"It's a lot more streamlined, and there's not a lot of counseling required now. Treatment is available, and there's a lot of literature that says that life expectancy is up to near normal if people engage in care early and take care of themselves.
"There are cancers, and many, many other diseases that have far worse outcomes than HIV that people deal with on their own without a lot of counseling."
Of the 1.2 million Americans living with HIV in the United States, the Centers for Disease Control and Prevention estimates that 20 percent don't even know that they're infected and account for more than half of the 50,000 new infections a year in the United States.
Whether people most at risk -- African-American gay-bisexual men, especially those between the ages of 13 and 24, according to the CDC -- will have the money and motivation to go to the drug store and pay $40 for the home test is another question, Walensky said.
Even if they have the $40 to spend on an HIV home test, many won't be able to buy it anyway, because the OraQuick home test cannot be sold to anyone younger than 17, and requires ID.
"Any availability of any test anywhere is a good thing," Walensky said. "Whether this is going to be an epidemic game-changer is where I have to opt out."