Roche gets test approved as a Pap smear alternative

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.

“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.

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 an 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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