Roche Holding AG (ROG) won U.S. approval for the first test to screen for cervical cancer that will serve as an alternative to a Pap smear.
The test detects DNA from 14 human papillomavirus types, the most common sexually transmitted infection, that are associated with cervical cancer, the Food and Drug Administration said yesterday in a statement. Basel, Switzerland-based Roche’s test had been approved in 2011 for use with a Pap smear, which scrapes cells from the opening of the cervix to examine under a microscope, or as a follow-up to the procedure.
An estimated 12,360 women will be diagnosed with cervical cancer this year and 4,020 will die from the disease, according to the National Institutes of Health. Roche’s test primarily detects two types of HPV responsible for about 70 percent of cervical cancers, which if found should be followed by a procedure known as a colposcopy that may include a cervical biopsy.
“We are committed to working with the medical community and professional organizations to put the necessary clinical practice guidelines in place to encourage providers to incorporate this new screening strategy alternative in their patient protocols,” Roland Diggelmann, chief operating officer for the Roche Diagnostics division, said in a separate statement.
If the test detects one of the other 12 HPV types, patients should follow up with a pap test to determine the need for a colposcopy.
A coalition of patient and consumer groups wrote the FDA earlier this month with concerns the test is “a radical change” to current guidelines that recommend Pap smears every three years starting at age 21 with the option of a using a combination of a Pap smear and HPV test at age 30. The groups, including the American Medical Women’s Association and the National Organization for Women, say there isn’t enough data comparing HPV screening with the combination method.
“Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in the agency’s statement.
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