The Food and Drug Administration‘s Medical Devices Advisory Committee Microbiology Panel agreed by a vote of 13-0 that a HPV test developed by Roche should be approved by the FDA as a primary tool for cervical cancer screening.
Currently, women are tested for human papillomavirus (HPV) during a Pap test – examining a cervical sample under the microscope looking for abnormalities. – or after a Pap smear shows abnormal changes on their cervix. The new cobas® HPV test from Roche detects the DNA of human papillomavirus which causes almost all cases of cervical cancer.
Sources and More Information
- F.D.A. Panel Recommends Replacement for the Pap Test
The New York Times, 12 March 2014
- FDA Panel: Roche’s DNA Test Can Replace Pap Smear
MedPageToday, 12 March 2014
- cobas® HPV Test, Roche Molecular Systems, 3 March 2014