OraSure ready to take on O-T-C market with oral HIV test

July has been a big month for Bethlehem’s OraSure Technologies Inc.

The maker of oral fluid diagnostic products received approval from the Federal Drug Administration (FDA) on July 3, to begin selling its OraQuick in-home HIV test.

The decision was groundbreaking not only because OraSure became the first company to receive FDA approval for the sale of an over-the-counter HIV test, but also because OraSure became the first company to receive such approval for an over-the-counter test for any infectious disease.

Now, after seven years of research and development on the product, the company can finally start on the manufacturing and marketing of the over-the-counter version of the test.

Ron Ticho, senior vice president of communications for OraSure, said the company has added marketing and sales professionals to its staff and is partnering with marketing and public relations firms that specialize in the pharmaceutical industry to prepare for a planned October launch of the product. He said he expects the product will be carried in more than 30,000 retail locations nationwide.

“We’re switching over to marketing and education, raising the awareness of the product,” he said.

The news has had the obvious impact on the company’s stock value.

In the days after the news OraSure’s common stock (OSUR) jumped to a 52-week high of $14.01 from around $11 just before the announcement – and more than double the year’s low of $6.29. By last week the price had settled at just under $13.

Not missing a beat, OraSure last week announced a common stock offering of 6.1 million shares at the price of $12.30, slightly less than the high of $12.78 the stock was fetching on Wednesday, July 11.

OraSure president and CEO Doug Michels stated that the company expected to net approximately $70.2 million from the offering.

“We will be using the proceeds from the recent stock offering for general corporate purposes,” said Michels.

Now that this product is ready for market, Ticho said there are no immediate plans to put any other product testing in the pipeline. The company is surely going to have its hands full, he said.

“There’s quite a demand for this product,” he said. “Our focus right now is making sure we have this product ready for market.”

Ticho also noted that, while surely the highest profile product the company has, the OraQuick HIV test is only one of its new entries into the market in 2012.

He noted that the company began selling its Rapid Hepatitis C test to physicians’ offices earlier this year. OraSure’s Hepatitis C test is fingerstick-based and needs a lower level of training to perform the test than a fully equipped lab and can be performed in most any doctor’s office.

But the company is excited about the prospects for its new over-the-counter HIV test.

“We set out with a clear purpose – to dramatically impact the number of people getting tested for HIV nationwide,” said Michels. “FDA approval of our OraQuick In-Home HIV Test brings us much closer to accomplishing that goal.”

Stacy Wescoe
Writer and online editor Stacy Wescoe has her finger on the pulse of the business community in the Greater Lehigh Valley and keeps you up-to-date with technology and trends, plus what coworkers and competitors are talking about around the water cooler — and on social media. She can be reached at stacyw@lvb.com or 610-807-9619, ext. 4104. Follow her on Twitter and on Facebook.

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