Alumnus Douglas Michels is the top executive of OraSure, the company behind OraQuick, a simple self-administered test to diagnose HIV at home.
Wander the aisles of any major drug retailer and, among the mouthwashes and antacids, you’ll find an over-the-counter product that is saving lives: the OraQuick HIV test. The Centers for Disease Control and Prevention (CDC) estimates that, of the 1.2 million Americans infected with HIV, 20 percent don’t know they’re infected; for those at risk who’ve hesitated to get tested, OraQuick, introduced in 2012, is a game-changer. You can pick up the test for $40, bring it home, and, after a mouth swab, see your results in 20 minutes.
“The Federal Drug Administration’s (FDA) approval of OraQuick was a landmark decision, from two perspectives,” says Douglas Michels, the chief executive officer of OraSure Technologies, Inc., the company that developed and manufactures the test. “It’s the first self-test for HIV that the FDA has ever approved and the first self-test for any disease approved by the FDA.”
Michels RBS’90 was recruited as CEO of OraSure in 2004, four years after the company was founded to develop, manufacture, and market cutting-edge medical products. With a bachelor of science in public health administration, a master of business administration, and 25-plus years’ experience in the business of health care at Johnson & Johnson and Abbott Laboratories, Michels was an inspired choice to help the fledgling firm develop a long-term growth strategy. His market analysis revealed a growing demand among health care professionals for diagnostic tests offering near-instant results on site. “And it was out of that analysis,” he says, “that we committed to build our capability in rapid, point-of-care diagnostics specifically directed to infectious diseases.”
Under Michels’s leadership, OraSure has become adept at translating medical research into marketable products. (The company employs a team of researchers but also collaborates with most of the world’s leading research institutions, Rutgers among them.) In 2002, OraSure introduced an HIV point-of-care test for use in doctors’ offices and other health care settings; for the first time, patients could get their results in minutes rather than weeks. A subsequent OraSure survey of 4,000 sexually active adults indicated what Michels calls “a high level of interest” in a home test for HIV, but there were concerns among the HIV/AIDS community and the FDA that the test would be difficult to use, or that a positive result might be overwhelming to a consumer using the test alone.
The result was an unusually detailed, yet easy-to-follow instruction booklet, a website featuring a six-minute video, and a 24/7 helpline. Since its introduction, there have been questions about the test’s reliability, largely based on the results of a clinical trial in which 1 out of every 12 consumers reported a false-negative result. Michels responds that “this is the same test used with confidence by health care professionals since 2004, and more than 30 million units have been sold.” In fact, the FDA voted unanimously to approve it in 2012, citing its potential to identify a significant number of undiagnosed infections. Today, the test is available in more than 30,000 stores and online, and Michels estimates that the U.S. market alone is worth $500 million or more.
The company is now targeting individuals with hepatitis C. In 2013, OraSure introduced the first, and only, rapid point-of-care hepatitis C test for health care professionals, not long after the CDC recommended that all baby boomers be tested for the disease. (Hepatitis C affects roughly 3.2 million Americans, though only a third know they’re infected.) The test, Michels says, “could realize a high yield of undiagnosed patients, connect them to new therapies, and cure them”—an exciting proposition for a man with a lifelong passion for public health.