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Bethlehem-based OraSure's at-home HIV test hits store shelves

Published On: Oct 08 2012 08:00:00 PM EDT   Updated On: Oct 09 2012 06:10:16 PM EDT

You don't need to be a doctor or visit with one to get an important diagnosis on your health.

You don't need to be a doctor or visit with one to get an important diagnosis on your health.

A home HIV testing kit from Bethlehem-based OraSure is now available over-the-counter at stores everywhere.

The at-home test received approval from the U.S. Food and Drug Administration on July 3.


The president of the company said he hopes the test will increase the number of people learning their HIV status.

They've been working on the at-home test since 2005 with four presentations to the FDA and a lot of clinical trials.

“We're extremely excited to finally have this product FDA-approved and now, today, available in 30,000 retail outlets across the country," said Douglas Michels, president and CEO of OraSure Technologies Inc., which released OraQuick.

The at-home HIV test gives consumers results in 20 minutes. Previously, the rapid test was available only to medical professionals.

“What we are doing today is making that exact same test available to consumers so that they can use the product in the comfort and privacy of their own home,” added Michels. 

The test is easy to use. Just swab your mouth and then place the swab in the testing kit.

The company noted the test is 99.9 % accurate in people not infected with HIV and 91.7 % accurate in people infected with HIV.

Part of the FDA approval was making sure the company set up a call center.

“Fully trained, bilingual representatives who could support the consumer," said Michels. "Whether the consumer had questions in how to perform the test, how to interpret the results, or most importantly, how they could access referral services.” 

Michels said he hopes the test will allow more people to learn their HIV status.
He said he feels at-home testing will reduce the amount of people scared to take the test, and the stigma of asking for one at the doctor's office.

“We're not looking to replace all the great work that goes on in doctors offices, hospitals and public health clinics around the country," said Michels.

While Michels said OraSure is helping the health industry, the company will also make a financial gain.

Company financial experts estimated OraSure will make $500 million in gross revenue.