OraSure Technologies CEO Douglas Michels walks softly and carries a small stick. Actually, the stick is a white, plastic HIV test that uses oral fluid, is quick and has been approved by the FDA for use by health-care workers--and Michels packs it in his briefcase wherever he goes. Last month he whipped it out to show AIDS activist and actress Angelina Jolie in Washington, and then again to show distributors in Japan. This month he'll be demonstrating it before FDA scientists, in hopes of getting the test approved for over-the-counter use as soon as next year--a major step for the company. Each time, Michels swabs his upper and lower gums, gathering up antibodies with the stick's absorbent pad. He then dips the swab in a vial of developer so that chemicals on the stick can look for HIV antibodies. Twenty minutes later, he gets a result that's 99 percent accurate. "I carry it wherever I go," Michels says. "It's impactful."
The OraQuick Advance Rapid HIV-1/2 Antibody Test has certainly had an impact on the bottom line of the 235-employee public company. OraSure received FDA approval for the test in 2004 and expects to be fully profitable this year for the first time. Founded in 2000, the company says it's on target to bring in $70 million in revenue, up 30 percent from last year. Oral fluid is OraSure's specialty: it makes a drug test used mostly to screen for illegal substances in the workplace and is developing another rapid test for hepatitis C. But it is the HIV test that has the company scrambling most to keep up with demand, which will skyrocket if it gets over-the-counter approval.
OraQuick's modern buildings are located in Bethlehem, Pa., within sight of the old blast furnaces of Bethlehem Steel. "Technology saved this town," says vice president Ron Ticho. Now OraSure believes it is saving lives. South African mining giant Anglo American uses OraQuick to test many of its 130,000 employees because early detection increases survival rates. Anglo American tracks HIV testing rates as if they were stock prices. That's because sick workers' low productivity and absenteeism affect the company's bottom line. Testing, and treating, employees is not only moral--it's economical. Last year Anglo American screened about 20 percent of its work force, twice as many as the year before. Dr. Brian Brink, senior vice president for health at Anglo American South Africa, says employees often refused the voluntary tests out of fear of dirty needles. Now, Brink says, they're much more willing to take the "toothbrush"--their nickname for the test.
Michels sees part of his job as being a humanitarian. He sells his product in developing countries for $5 a test, about a third of the price in the United States. He's also hired former White House AIDS czar Scott Evertz, who met with health ministers in Africa last month about making OraQuick more widely available through government-run health clinics. Back home, OraQuick is already a mainstay. The Centers for Disease Control and Prevention has been buying OraQuick tests in bulk and distributing them to clinics and even mobile testing units. Since the test doesn't require a doctor or generate biological waste, it can be used widely. The number of people actually getting their test results has increased dramatically because of OraQuick. In New Jersey's publicly funded testing sites, for example, 34 percent never came back for their results from the old test, which could take two weeks. With the new 20-minute test, nearly 100 percent get their results.
The next step is considering whether people should be allowed to take the test at home. Michels hopes OraQuick will follow the same path as the home pregnancy test. But with ethical questions surrounding that decision--are positive results best delivered by a physician or counselor?--Michels will face a lot more questions from the FDA than he can shake his stick at.