The company has sold more than 25 million rapid HIV tests to clinics and testing centers around the world since 2002, when it won approval for the first rapid blood test for HIV. All were manufactured in Bethlehem.
The product that was recommended for home use on Tuesday is identical to the oral version of that test, which was approved in 2004, except for the packaging, labeling, and support services.
As a result, the company has said it could begin selling the test at pharmacies and online within 60 days of approval by the FDA. The agency typically follows its advisers’ recommendations but is not required to.
More than 20 HIV activists, doctors, and public health workers testified at the Blood Products Advisory Committee hearing. They overwhelmingly supported the OraQuick In-Home HIV Test, often in passionate terms.
“I envision my parishioners coming to me and saying, ‘Pastor, will you sit 20 minutes with me while I take the test?’ ” said Calvin O. Butts 3d, of the Abyssinian Baptist Church in New York, adding that they might never go to a clinic for a test and so would never know whether they had HIV.
Tom Donohue, who grew up in Williamsport, Pa., recalled discovering he was HIV positive while a student at Penn State University.
“I know what it’s like to wait for results, I know what it’s like to share my sexual history before a community member who is an HIV tester,” said Donohue, who founded and is executive director of Who’s Positive, an HIV awareness organization.
By Don Sapatkin