FDA approve first HPV test for primary screening of cervical cancer
Due to an increase in cervical cancer screening, death rates from the disease declined by almost 70% between 1955 and 1992, emphasizing the importance of such testing. Now, the Food and Drug Administration have approved the first human papillomavirus DNA test for primary cervical cancer screening for women aged 25 years and over.
At present, there are two main techniques used for cervical cancer screening. The first is liquid-based cytology. This involves a doctor or nurse collecting cells from the patient's cervix with a small brush. The head of the brush is then detached, preserved in liquid and sent to a laboratory to be tested for abnormalities.
But the most common form of cervical cancer screening is the Papanicolaou (Pap) test, also referred to as a cervical smear test. This involves a doctor or nurse scraping cells from the opening of the patient's cervix, before sending them to a lab to be assessed for abnormalities.
However, the Food and Drug Administration (FDA) say the newly approved test offers women an alternative option for cervical cancer screening.
Cobas HPV test a 'safe and effective' alternative
The cobas human papillomavirus (HPV) test, developed by Roche Molecular Systems, can detect 14 types of HPV that present high risk of cervical cancer. Specifically, the test identifies HPV 16 and HPV 18 - the two types that are responsible for around 70% of cervical cancer cases.
The FDA has approved the first HPV test for primary cervical cancer screening, which will offer an alternative to Pap tests for women aged 25 or over.
If the test detects HPV 16 or HPV 18, a patient will be required to undergo a colposcopy, where a device is inserted into the cervix and illuminates and magnifies the area, allowing direct observation of cervical cells.
If the cobas HPV test detects any of the other 12 high-risk HPV types, patients will then be required to have a Pap test, which will determine whether they need a colposcopy.
The test was previously approved by the FDA in 2011 for use in conjunction with a Pap test, or as a follow-up. But this most recent approval means the test can now be used as the first port of call for cervical cancer screening for women aged 25 years and over.
According to the FDA, a study conducted by Roche involving more than 40,000 women, known as the ATHENA HPV trial, has shown that the cobas HPV test is safe and effective.
The women in study were aged at least 25 years and underwent a cobas HPV test and a Pap test. Women whose cervical cells screened positive for HPV using the cobas HPV test or who had a positive Pap test, as well as women who had negative Pap and HPV tests, had a colposcopy and cervical tissue biopsy.
Biopsy results were compared with both the cobas HPV test results and the Pap test results.
The study found that the cobas HPV test could accurately identify HPV 16 and HPV 18 in women, therefore predicting a woman's risk for cervical cancer.
Commenting on the approval of this test, Alberto Gutierrez, PhD, of the FDA's Center for Devices and Radiological Health, says:
"[This] approval offers women and physicians a new option 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."
Earlier this year, a spotlight feature from Medical News Today discussed the importance of regular cervical cancer screening and the signs and symptoms of the disease.
Written by Honor Whiteman
Copyright: Medical News Today
Not to be reproduced without the permission of Medical News Today.