A human papillomavirus (HPV) test for cancer screening has won the support of an FDA advisory committee to replace the Pap smear. The advisory committee voted unanimously 13-0 on Wednesday in support of HPV test as the first-line standard of care for cancer screening. The cobas viral DNA test for HPV is developed by Roche Molecular Systems and it was declared as safe and effective for cervical cancer screening.

It was claimed that the benefits of the tests outweigh the risks associated with the test in question. The current approval of the cobas test is for a follow-up assessment for women in and older whose pap tests have been abnormal. Women between 30 and 65 years can have cobas test performed on them as co-test with the Pap smear to figure out the high-risk p16 and p18 HPV strains in them.

Roche proposal intends to have women 25 and older who test positive for HPV16 or 18 directly go for colposcopy for further assessment.

Pap test to determine the need for colposcopy would be performed on patients who have been tested negative for HPV16 or 18, but positive for other high-risk strains.

Panel member Paula Hillard, MD, of Stanford University in California, said, "I am concerned that all those women potentially with other high-risk positivity won't go to Paps next but go straight to colposcopy. That's not what's proposed here, but what control does FDA have once it's out there".

HPV is a virus that is transmitted sexually and majority of cervical cancers are attributable to this virus. HPV 16 and 18 are among some strains that are most strongly associated with these tumors. Genital warts are also caused by the virus among both men and women andscertain head and neck cancers.

Dr. Andrew Menzin, a gynecologic oncologist at North Shore University Hospital in Manhasset, NY, has said that there is no doubt that HPV testing has emerged as the most remarkable advance in cervical cancer screening.