On Mar. 17, 1999, the Hybrid Capture II human papillomavirus (HPV) DNA test was approved by the U.S. Food and Drug Administration (FDA) as a test that can be used in conjunction with the Pap smear in screening for cervical cancer.

The device, as modified, was marketed under the trade name Digene HPV Test Using Hybrid Capture(R) II Technology (HCII HPV).