Saturday - May 18, 2024

FDA Supports HPV Test for Cervical Cancer Examination

woman undergoing gynecological examination

Recently, the U.S. Food and Drug Administration announced its endorsement for the use of Human Papillomavirus Test or HPV test as a primary screening tool for cervical cancer.   This development is significant in the field of health care because HPV test is the first ever DNA test that is approved by FDA.  The screening test can be used for women ages 25 years old and above and it is a good indicator whether the patient will have to undergo further testing for earlier detection of cervical cancer.

What is Cervical Cancer?

According to the National Cancer Institute, in 2013 approximately 12,000 new cases of cervical cancer in United States were diagnosed and 4,000 deaths were recorded.  Cervical cancer  is formed in the cervix.  The cervix is a lower contracted part of the uterus which is connected to the vagina.  Human Papillomavirus is the microbial agent that causes cervical cancer.  

The best way to prevent the spread of cancer is to be vaccinated and to have regular pap smears. If detected early, cervical cancer is curable.   The FDA has endorsed HPV testing as an effective and safe diagnostic test to detect cervical cancer.  This has been reconized as a breakthrough in the field of medicine.  It will greatly help physicians and other health care professionals in determining whether a patient needs to undergo further screening such as a colposcopy.  This is a simple examination where a colposcope is  used by physicians to view the female genital organ particularly the vagina and the cervix.  It is also used to harvest a sample for further diagnostic testing.

HPV Testing

HPV test is  used to determine whether a patient is at a high risk of contracting cervical cancer in the future.    The test is performed by taking cervical cell samples; the results easily detect which among the 14 DNA strains is of high-risk for cancer. Specifically, the test can determine two high-risk HPV genomes namely HPV 16 and HPV 18.

Women who test positive to having HPV 16 and HPV 18 are recommended to undergo further testing. Those who are also positive in one or two high-risks HPVs are usually advised to have a  pap smear, this will determine whether further testing in the form of a colposcopy is need. Physicians may use the result of Cobas HPV test along with the patient’s medical history and other risk factors to diagnose the severity of the illness.

It is important to note that the human papillomavirus test is the first ever DNA test approved by FDA which is used as a first-line screening test in detecting high-risk HPVs. It can be used solely as an indicator of cervical cancer by identifying high-risks genotypes such as HPV 16 and HPV 18.   These two genotypes cause 70% of recorded cervical cancer cases in the United States.  
Prior to 2011, HPV test was used for women age 30 and above as a follow-up test after cell cytology or in combination with cell cytology.  It is also used for women age 21 and above as follow-up test for abnormal results in cell cytology. Three years later, HPV test can now be used as a stand-alone test to determine the occurrence of getting high-risk HPV.

HPV test will open doors

According to Alberto Gutierrez, Ph. D., the director of the Office in Vitro Diagnostic  at the FDA’s Center for Devices and Radiological Health, the approval of the HPV test will open doors for physician and their patient to have an effective  option in determining onset of cervical cancer.

In a statementDr. Gutierrez,  strongly advised that the study conducted by Roche Diagnostics was extensive and comprehensive enough because they were able to provide a rational assurance of the effectiveness and safety of using HPV test as a primary screening tool in determining cervical cancer.   The study included 40,000 cases of 25 year old and above women who underwent a regular cervical exam.

The results revealed that women, who tested positive for cervical cells screened with HPV, or those women who tested positive in a Pap smear, were asked to have a biopsy of cervical tissue.  The biopsy results were compared to the HPV and Pap smear test.  A three year follow-up study was conducted with these women.  The data gathered concluded that the HPV test is an effective and safe diagnostic tool to use in the early detetion of cervical cancer.


One of the solutions in preventing cervical cancer is early detection through the use of various screening test. Cervical cancer can be prevented and cured if given proper medical attention.  Hence, the support of FDA for the use of HPV tests is significant in the crusade to fight cervical cancer.