(Bloomberg) — Roche Holding A.G. 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 types of human papillomavirus (HPV) types that are associated with cervical cancer, the U.S. Food and Drug Administration (FDA) said Thursday in a statement.
The Roche test had been approved in 2011 for use in conjunction with a Pap smear, or as a follow-up to the procedure.
A Pap smear typically costs about $40 per test, and an HPV DNA test costs about $80 per test.
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. If the test detects those two types of HPV, a woman should have a procedure known as a colposcopy that may include a cervical biopsy.