FDA Approves New Alternative to Pap Smear
(NEW YORK) — The Food and Drug Administration approved a genetic test as the first approved alternative to the pap smear, the agency announced Thursday.
The human papillomavirus test screen for women 25 and older will help health care professionals assess whether patients need to undergo additional testing for cervical cancer, and can also give information on a woman’s risk for developing the disease in the future.
The cobas test uses a sample of cervical cells and detects DNA. Doctors are still encouraged to use the exam results along with other data such as patient screening history and other factors.
While the FDA first approved the test in 2011, it was only for use with the Pap smear, or as a follow-up to the procedure. Thursday’s approval allows health care professionals to implement the cobas method as a primary cervical cancer screening test.
Genital HPVs are the most commonly sexually trasmitted infections, according to the Center for Disease Control and Prevention. Approximately 14 “high-risk” types are associated with cervical cancer.
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