Cobas Test Could Replace Pap Smears, According To Unanimous FDA Vote

A U.S. Food and Drug Administration panel voted unanimously that a new HPV test could replace the Pap smear when testing for cervical cancer.

HPV is a sexually transmitted virus that is believed to be responsible for most cases of cervical cancer, WebMD reported. The strains HPV 16 and 18 are most closely linked with cervical cancer tumors.

The cobas test is currently approved for follow-ups in women over the age of 21 who have received an abnormal Pap smear, MedPage reported. Women who test positive would undergo a colonoscopy.

"Cervical cancer screening has been a huge success in decreasing cervical cancer incidence and death," Doctor David Chelmow, chair of the department of obstetrics and gynecology at Virginia Commonwealth University School of Medicine told the panel, WebMD reported.

"The idea of reversing the order of testing is an approach to try to refine and minimize who [unnecessarily] goes on to colposcopy," Doctor Andrew Menzin, a gynecologic oncologist at North Shore University Hospital told WebMD.

The main benefit of the new test will be to identify whether or not the patient needs a follow-up colonoscopy and minimize those who are unnecessary prescribed the procedure.

Current guidelines suggest the Pap test still be administered before the new test, "but the guidelines continue to evolve," Menzin told WebMD.

"The data show that the proposed primary screening indication for the cobas HPV test detects more women with disease and requires fewer women without disease to go to colposcopy than cytology alone," a summary submitted by FDA staff members said, MedPage reported.

Most people who contract HPV do not develop any symptoms, the U.S. Centers for Disease Control and Prevention reported. Certain types of HPV can cause genital warts or warts in the throat. The virus has also been more loosely connected with cancers of the "vulva, vagina, penis, anus, and back of the throat," the CDC reported.

Real Time Analytics