FDA approves first HPV test for primary cervical cancer screening

The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.

Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs.

Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, an exam using a device that illuminates and magnifies the cervix so a physician can directly observe the cervical cells. Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Health care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.

“Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “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.”

The FDA first approved the test, called the cobas HPV Test in 2011 for use in conjunction with or as a follow-up to a Pap test (cell cytology), which examines cervical cells for changes that might become cervical cancer.

Today’s approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test, however; it does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed and modified by groups other than the FDA.

Genital HPVs are a group of more than 40 related viruses and, according to the Centers for Disease Control and Prevention (CDC), are the most common sexually transmitted infections. Approximately 14 “high-risk” HPV types are associated with cervical cancer.

In most cases, a high-risk HPV infection goes away on its own and does not cause any health problems. However, about 10 percent of women infected with high-risk HPV develop a persistent infection which may put them at risk of cancer. Virtually all cervical cancers are caused by HPV infections, with just two types, HPV 16 and HPV 18, responsible for approximately 70 percent of cervical cancers.

Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women 25 years and older undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results.

Data from this study, which included three years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use. The cobas HPV Test is manufactured by Roche Molecular Systems, Incorporated, Pleasanton, Calif.

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7 thoughts on “FDA approves first HPV test for primary cervical cancer screening”

  1. To all the bloggers who found this article interesting and relevant, here is something to make you proud and excited. In order to protect girls from getting cervical cancer caused by Human Papilloma Virus, the Republic of South Africa has made a decision to conduct a national vaccination campaign in 2014 to vaccinate girls in grade four who are 9 years and older. The new policy has been implemented for the extended program for immunizations in Bloemfontein on 12 March 2014. Minister of Health, Dr Aaron Motsoaledi together with the Deputy Minister Dr Gwen Ramokgopa administered the first dose of the newly launched Human Papilloma Virus (HPV) vaccination campaign. 54 eligible girls received the HPV Vaccine on the day and about half a million girls countrywide will get this vaccine. Unfortunately this does not yet cater for the older generation of females in our country and that is where the cobas HPV Test will help us. This also opens the door to new technologies where hopefully more of the HPV viruses can be detected before it turns into one of the numerous cancers it causes. Much focus is now placed on the one type of cancer and it is research and dedication like this that allows for focus to be placed on the less known cancers that the HPV causes. It is inspiring to me when I read articles such as this one and this does trigger my interest to investigate and gain more knowledge on the related fields.

  2. Cancer of the cervix is the second most common form of cancer among SA women. Approximately, 1 in every 41 women will , within their lifetime, develop this form of cancer. Pap smears have been the best known form of secondary prevention. However, your gynaecologist will often make it abundantly clear to you that the Pap smear alone is a less than perfect screening procedure.
    Cancer of the cervix develops over time(10-20 years) from a precursor lesion which is often invisible to the naked eye so the investigative procedures Cobas HPV test and the follow up colposcopy are particularly valuable when used as a test battery.
    DNA tests have always been costly and the study does not make reference to the cost factors involved. In the South African context this may be too expensive and thus prohibitory to implementation into the current cervical cancer screening programs in our state hospitals.
    A holistic approach to cervical carcinoma prevention is also vital i.e screening and primary prevention such as increasing public knowledge and assisting individuals in making healthy lifestyle choices. The latter will include managing SDT’s, stop smoking, postponing sexual activity to an older age, using barrier methods during intercourse etc.

  3. It is greatly troublesome to woman all over the world to think that approximately 10% of woman who contract a ‘high risk’ HPV strain are highly likely to develop cervical cancer. However owing to the profound advancements in the scientific community our fear is greatly reduced. I believe that the approval and the implementation on the cobas HPV test will alter womans’ lives for the better. The fact that it is non-invasive makes it less frightening and it’s likely that more woman will chose to have it done. When results are received they can be assured that the results are accurate because it has been successfully tested. The test will also serve as a ‘wake-up call’ to woman, encouraging them to live a healthy lifestyle and it simultaneously increases the awareness of the risks of HPV. Moat importantly the test can also provide information about the patients risk for developing cancer in the future. With this knowledge woman are able to effectively plan and or change their lives so that that don’t contract cancer. Prevention is better than treatment!

  4. I heard about the Human Papillomavirus in 2011, and decided on that day, that I needed to get vaccinated against becoming a statistic. I did not get any tests to check whether or not I might or might not one day have cervical cancer. I made an appointment and got the 3 injections (Gardasil), spaced over about 6months, and now I have immunity from HPV which equals protection against cervical cancer.

    Its great that the FDA has approved this HPV DNA test, although… should they not just make it a necessity for all young women to get vaccinated?
    Prevention is better than cure.

    To all females reading this comment, I urge you to make an appointment with your doctor and invest in your health. It is alittle pricey, but I hear cervical cancer carries a huge price tag.
    It will be the best gift you give yourself.

  5. This is one of the many advances in science that have benefitted woman today and improved awareness of the subject of cervical cancer. Many people do not realise that the probability of getting this type of cancer has increased over the past few years. This test will now help to decrease this percentage and encourage woman to take control of their health before it is too late. Early detection is the key and this is what this test if providing and because it is a non-invasive procedure, woman should not be afraid. It will now help them to maintain a healthy lifestyle knowing that they are being proactive.

  6. With the increase of cervical cancer in women nowadays, the need for a testing program to help determine whether a woman has the cervical cancer gene is a necessity. The procedure is non-invasive making that a plus point to encourage women to undergo the test. It will help women determine their future, have better control over their health and help them maintain a healthy, balanced lifestyle to aid themselves in the fight against cancer.

  7. Cervical cancer is a great worry for all woman. This new test discovered allows woman to be tested noninvasively for the cervical cancer gene. It will help women to feel more in control of their bodies and will help them to prepare for any probabilities of cervical cancer in the future.

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