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By Alexander Moschina

Over the past 27 years, our greatest tool in battling the HIV virus has barely changed.

Until now.

A Pennsylvania biotech company is currently awaiting FDA approval for the first ever over-the-counter HIV test.

In just 20 minutes, the test will reveal whether a person has contracted the virus. No health clinics or hospitals. No agonizing waiting for lab results.

Needless to say, a take-home HIV test is huge news – and could be a game-changer for the company. If it’s approved, the business – and share price – will blast significantly higher.

And the company behind it?

On the Cusp of Reshaping a Multibillion-Dollar Industry

Since 1979, OraSureTechnologies (Nasdaq: OSUR) has held a leading position as a manufacturer of medical testing products. Among the solutions are one that can quickly test patients for drug/alcohol abuse, as well as diseases like Hepatitis C (HCV) and HIV.

The company sells these devices to doctors’ offices, government agencies and health organizations worldwide. And pending FDA approval, its OraQuick HIV test could soon be behind the counter at your local pharmacy.

Not only would this would create a brand new revenue stream for the $230 million firm, but approval would also instantly expand OraSure’s share of the global HIV/AIDS testing market.

And that market is projected to reach $3.5 billion in less than five years. A take-home HIV test could propel this number even higher. After all, more individuals would undergo testing if they could easily do so in the privacy of their own home.

And as the sole provider of these tests, OraSure’s profits are on the verge of exploding.

Even better, if the government approves its HIV test for over-the-counter sale, approval for a take-home version of its award-winning Hepatitis C test could be next…

OraSure’s Award-Winner Could Make It the Leader of a Second $2 Billion Market

On November 17, 2010, the OraQuick HCV test received Popular Science Magazine’s top prize – the “Best of What’s New” award. “[Winners] represent the highest level of achievement in their fields,” said Editor-in-Chief, Mark Jannot.

OraSure is again tapping into a mammoth market here, with 180 million people worldwide stricken with HCV. But with 80% of them showing no symptoms, that’s why the OraQuick HCV Test is such a major development. Like HIV, early detection is the key to successful treatment.

Today, the product is only used in medical labs. But OraSure is working with the FDA to gain approval for use in the field by minimally trained staff. An application for over-the-counter sale could be next.

Approval would grant the company a massive share of this $2 billion market – one that could triple by 2014.

But best of all? The simple fact that OraSure is already a leading medical technology company. It boasts a strong position in its industry and sales of its products have grown steadily over the last 12 months. And its share price is up 83% over the past six months.

Plain and simple, the company is a winner. And take-home approval of its products may soon make it a superstar.

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