U.S. patients now have the option to collect their own clinical samples for cervical cancer screening with the introduction of new self-collection tests as a convenient alternative to traditional Pap smears. The Food and Drug Administration (FDA) recently approved self-collection as a method to detect human papillomavirus (HPV), the leading cause of cervical cancer. These tests are set to be available in doctor’s offices across the country starting this month.
The FDA approval for self-collection testing allows patients to collect their own clinical samples for cervical cancer screening. This approach has already been widely used in countries such as Australia, Canada, the Netherlands, Denmark, and Sweden. While self-sampling for HPV at home is permitted in some countries, it is still pending FDA approval in the United States. Currently, samples must be collected in health care settings, such as doctor’s offices.
HPV, a common sexually transmitted infection primarily transmitted through sexual intercourse or skin-to-skin contact, is the leading cause of cervical cancer. While most sexually active individuals will contract at least one type of HPV in their lifetime, the infection typically resolves on its own. However, high-risk HPV strains are associated with cancer, with almost all cervical cancer cases caused by long-term infections with these strains.
The HPV vaccine has been shown to protect against most cases of cervical cancer. A study published in the Journal of the National Cancer Institute found zero incidence of invasive cervical cancer among young Scottish women who had received at least one dose of the HPV vaccine. Women who received three doses of the vaccine were significantly less likely to develop cervical cancer than those who were unvaccinated.
Cervical cancer screening typically involves an HPV test and a Pap test. An HPV test can detect the genetic material of high-risk HPV strains that can lead to cancer if left untreated. A Pap test checks for changes in cervical cells that could indicate cancer. These tests are not diagnostic but are intended to identify individuals at high risk of developing cancer or precancer, leading to further testing if necessary.
Traditionally, both HPV tests and Pap tests required a sample of cells collected from the cervix during a pelvic exam performed by a doctor. However, the FDA’s approval of self-collection testing allows patients to collect samples from the vagina, making the process less invasive. Studies have shown that samples from the vagina are just as effective for detecting HPV as those taken from the cervix.
Regular cervical cancer screening is crucial in reducing death rates from the disease. Screening can detect precancerous changes in cells early, allowing for early treatment before cancer progresses to a more advanced stage. The American Cancer Society recommends that individuals with a cervix between the ages of 25 and 65 undergo a primary HPV test every five years or a co-test every five years. Alternatively, a Pap test alone can be done every three years.
The new self-collection tests offer several advantages over traditional Pap smears, including increased convenience and reduced invasiveness. Patients who may have avoided Pap tests due to physical or emotional discomfort, such as those with a history of sexual violence or gender dysphoria, may be more likely to undergo screening with the new self-collection option.
While self-collected vaginal samples are comparable to cervical samples collected by a doctor in terms of their ability to detect HPV, some patients may have concerns about performing the test correctly. However, studies have shown that even small samples collected by patients can effectively detect HPV.
Overall, the availability of self-collection tests for cervical cancer screening provides a more accessible and less invasive option for patients. By expanding screening options, more individuals may be encouraged to undergo regular screenings, leading to early detection and treatment of cervical cancer.