A Food and Drug administration (FDA) advisory panel has given its nod on an HPV (human papillomavirus) test that can be used to replace Pap smear for detecting cervical cancer.
FDA's Medical Devices Advisory Committee Microbiology Panel unanimously concluded on Wednesday that the cobas HPV test made by biotech company Roche can be safely and effectively used as a first-line screening tool for cervical cancer in women who are at least 25 years old.
"The U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV (Human Papillomavirus) Test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks," Roche said in a statement. "The panel also voted unanimously that the cobas HPV Test is safe and effective for the proposed indication for use."
The sexually transmitted HPV is behind a large majority of cervical cancers with certain high risk strains such as the HPV 16 and 18 responsible for 70 percent of the cervical cancer cases all over the world. Genital warts and certain cancers are also attributed to this virus.
Roche wanted its HPV test approved as a first step screening tool for cervical cancer. Women who are found positive for the high risk HPV 16 and 18 would be asked to undergo colposcopy, a procedure that would give the doctor a better view of a patient's cervix and tissues of the vagina and vulva, for further assessment and testing. Those who tested negative for the two strains but positive for other high risk strains, on the other hand, would undergo Pap test to assess the need for colposcopy.
"Every year, 12,000 women are diagnosed in the U.S. with cervical cancer," said Thomas Wright, Jr., Professor Emeritus of Pathology and Cell Biology at the Columbia University Medical Center in New York. "This is especially tragic because cervical cancer is a largely preventable disease, and it is well established that HPV is the cause of almost all cervical cancers worldwide. Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer."
Although the FDA is not bound to follow the recommendation of the committee, it will likely consider these recommendations in its own reviews. " If approved, the cobas HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States," Roche said.
