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FDA approves 2 cervical cancer virus tests - HPV

Posted Mar 17 2009 3:53pm

The new tests should be available at labs within a few months.  70% of the strains of the HPV that cause cancer can now be detected and those with high risk factors can find out and the new tests will result in fewer false positive results.  BD 

Hologic Inc., a Bedford-based women’s health care company, has received U.S. Food and Drug Administration approval for two new tests image for human papillomavirus.

Hologic’s Cervista HPV HR is expected to detect the 14 virus strains that can cause cervical cancer. Its other new test, Cervista 16/18, will help health-care providers more easily identify patients with HPV types 16 and 18, the two most common of the high-risk strains. Together, they cause 70 percent of all the cervical cancer in the United States.

“These new tests will further refine HPV testing and help us find women who are at the highest risk of developing cervical cancer,” said Gold, who reviewed some test-related data for Hologic.

Hologic gets FDA approval of cervical cancer virus tests - BostonHerald.com

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