HPV genetic test recommended for cervical cancer screening

18 March 2014

US regulator the Food and Drug Administration (FDA) is set to approve the first DNA-based screening test for cervical cancer.
 
The Microbiology Devices Panel of the Medical Devices Advisory Committee last week voted unanimously in favour of recommendation that Roche’s Cobas Human Papillomavirus (HPV) Test should be approved as a first line cervical cancer screening test.
 
Cervical cancer is a leading cause of cancer and cancer deaths among women, with around half a million new cases each year globally. It is thought to result almost exclusively from infections with certain high-risk types of HPV, which are sexually transmitted. Screening programmes aim to detect pre-cancerous changes and cancers early, when treatment has the greatest chance of success.

The Cobas test provides genotype data for HPV types 16 and 18, which together cause the majority of cervical cancers, as well as detecting twelve other types of HPV associated with increased cervical cancer risk. It has already been approved for screening young women with abnormal Pap (Papanicolaou) smear test results, or in addition to normal smear testing for older women.
 
The FDA is likely to accept this recommendation and approve the test for this new, first-line screening application in women under 25, in which case women who receive positive test results for HPV 16 or 18 will be referred for further investigation by colposcopy, women who are HPV 16/18 negative but test positive for any of the other 12 HPV types will receive cytological testing and be referred for coloposcopy if results are abnormal. It is hoped that the test will increase screening accuracy and particularly detection of cancer among younger women without increasing the number of unnecessary coloposcopy tests.

In the UK, cervical screening uses liquid-based cytology (LBC), rather than the Pap smear test; some areas of the country already screen first for HPV and only perform the cytology test on HPV positive samples. 

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