Third Wave's two human papillomavirus tests win federal approval

Two tests for human papillomavirus (HPV) developed by the Madison biotechnology company recently won approval from the U.S. Food and Drug Administration. That means Third Wave parent company Hologic, of Bedford, Mass., can start selling them to laboratories and clinics.

"There were quite a few people who choked back some tears when we got the letters from the FDA," said Greg Hamilton, Third Wave's vice president of operations, planning and analysis. The tests were the project of a team of 15 to 20 employees, mainly women, led by scientist Marilyn Olson.

The only other HPV test on the market, by Qiagen, checks for 13 variations and draws about $250 million a year in sales, said Howard Doran, Hologic senior vice president-diagnostics. He estimated the total market potential at $800 million a year worldwide for the two Third Wave tests.

HPV is the most common sexually transmitted infection in the U.S., the FDA says, infecting more than 6 million Americans a year. Some forms can lead to abnormalities in the cervix that can later become cancerous.

One Third Wave test checks for HPV types 16 and 18, believed to cause more than two-thirds of all cervical cancers. It is the first such test on the market. The second test can find 14 other types of HPV.

"Results from these two tests ... can help physicians better determine risk and could lead to better patient management," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.

Third Wave submitted 35 boxes of data showing the safety and effectiveness of the tests, which needed the FDA's highest level of scrutiny. Those reviews generally take 12 to 18 months, said Jorge Garces, Third Wave site manager and vice president of research and development. "For us to get approval ... in a 10-month period really speaks highly of the quality of the product," Garces said.

Hologic bought Third Wave last year for $580 million. Third Wave still has 135 employees in Madison and 30 in the field.

Meanwhile, two former Third Wave executives will lead Exact Sciences Corp., a Marlborough, Mass. company working on a test for colorectal cancer. Kevin Conroy, former Third Wave president and chief executive, will hold those posts at Exact. Maneesh Arora, former Third Wave chief financial officer, will be Exact's CFO.

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