FDA Approves HPV DNA Test for Women

The first HPV DNA test for cervical cancer screening got green signal from the FDA on April 24. The test called as the cobs HPV Test can be used by women aged 25 and above.

It works by detecting DNA from 14 types of HPV associated with high risk of cervical cancer, including HPV 16 and HPV 18 strains (both the strains are responsible for around 70% of cervical cancers).

Based on the results of the test, healthcare professionals will decide whether a woman should do further tests or not. If she gets tested positive for HPV 16 or HPV 18 then she should have a colposcopy done. In the second case, if woman tests positive for one or more of the 12 other HPV then she should have a Pap test.

For better results, it has been suggested doctors should see cobas HPV Test results along with other things like patient screening history, risk factors and current professional guidelines. Alberto Gutierrez, Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said the new test brings new hope for women and physicians for cervical cancer screening.

"Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer", affirmed Gutierrez.

In 2011, the FDA approved the cobas HPV Test to be used in conjunction with or as a follow-up to a Pap test. But the recent approval has extended the use of the test and can be used as a co-test or as solely cervical cancer screening test.

The test approval is based on a study of more than 40,000 women 25 years and older taking usual cervical tests.


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