Only a month ago, Keystone Edge reported that the first over-the-counter, oral swab test for HIV, being developed by
in Bethlehem, had passed an important FDA watershed.
Now comes news – on the front page of the New York Times
, no less – that the FDA has granted final approval to the OraQuick test, which will enable home users to swab their mouths and get a result in as little as 20 minutes.
It's major news for the company, which began discussions in 2006 with the FDA about a home version of its existing test used by health professionals. The kit is expected to be available at more than 30,000 retail outlets throughout the country and online in October.
Ron Ticho, OraSure's senior vice president, corporate communications, says the company doesn't yet know how many jobs will be created as a direct result of the FDA approval. "The company's focus right now is to ensure we have product for consumers in October. We do anticipate the product to be a growth driver for the company, but it's too early to determine the potential impact from a jobs perspective," he says.
As KE reported earlier, the potential for the company is huge with one analyst telling the Philadelphia Inquirer
that the test could generate $50 million in annual sales at the end of five years.
Source: Ron Ticho, OraSure Technologies
Writer: Elise Vider