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FDA Approves Roche’s HPV Test for Cervical Cancer Screening
Devices Submissions and Approvals
The FDA approved Roche’s cobas HPV test for first-line screening of cervical cancer in women 25 years and older.
The cobas HPV test is now approved for all cervical cancer screening indications included in professional society guidelines.
The test assists healthcare providers in identifying women at risk for cervical cancer by identifying the DNA of the HPV genotypes most responsible for causing cervical cancer, as well as high-risk genotypes.