New Self-Collection Medical Test Makes HPV Screening Easier for Patients

By LabMedica International staff writers
Posted on 09 Jan 2025

Image: The Roche Cell Collection Medium provides long-term stability for cervical specimens collected via self-collection (Photo courtesy of Roche)

Human papillomavirus (HPV) is the most prevalent sexually transmitted infection (STI) in the U.S. HPV spreads through skin-to-skin contact, typically during sexual activity with someone who carries the virus. There are over 200 types of HPV, but not all lead to cancer, including cervical cancer. Certain high-risk types of HPV can evade the immune system and persist in the body, damaging cells and potentially causing them to become cancerous. If cervical cancer is detected early, it can be completely cured. However, if diagnosed later, cervical cancer is much harder to treat and often incurable. Pap tests enable the detection of precancerous changes in the cervix, which can be treated to prevent cancer. HPV is a key indicator of these changes, and precancerous conditions rarely develop without the presence of HPV. Traditional cervical cancer screenings are performed during pelvic exams. At present, there is no standard medical test for high-risk HPV. However, there are various tests where patients collect their own samples, such as nasal swabs for COVID-19, urine samples for pregnancy, and stool tests for colorectal cancer. Now, tests for high-risk HPV, which can lead to cervical cancer, have also been added to this list.

In December, the U.S. Preventive Services Task Force released new draft guidelines recommending that women may self-collect vaginal samples for HPV testing during visits to their clinician. Experts believe this approach could increase screening rates and lead to earlier detection of cervical precancers and cancers. In May, the Food and Drug Administration (FDA) approved self-collection kits for use in a clinician’s office. The approved tests include Onclarity HPV from Becton, Dickinson and Company (BD, Franklin Lakes, NJ, USA) and cobas HPV from Roche Molecular Systems (Basel, Switzerland). These tests are similar to those used by gynecologists to screen for high-risk HPV and have shown to be very effective. Since the kits currently approved by the FDA are for collection in a clinician’s office, most patients will likely obtain them from their primary care provider. The patient is provided with an instruction sheet and a collection swab for insertion into the vagina. Afterward, the patient goes into a restroom to collect their sample and returns it to the clinician, who then sends it to a lab for analysis. In the future, self-collection from home may also become an option.

These tests make HPV screening significantly more accessible for patients who may not be able—or willing—to see a gynecologist for various reasons. Some may lack access to a gynecologist, have experienced trauma that makes pelvic exams particularly difficult, or have hectic schedules that cause them to continually delay their visit. If they visit their primary care provider, they can perform an HPV test right then. If the result is negative—indicating no HPV present—they will not need another cervical cancer test for five years. If the result is positive, they need to follow up with a gynecologist for further screening. Experts believe these tests will boost screening rates, help identify individuals with high-risk HPV, and reduce deaths from cervical cancer.

“I think this testing is going to make it much easier for women to ensure they are up to date with cervical cancer screening, said Caroline Goldzweig, MD, chief medical officer of Cedars-Sinai Medical Network. “Many women see primary care physicians who may not routinely perform pelvic exams, and having to make a separate visit to a gynecologist can be a barrier for patients. Cervical cancer is so preventable, given what we now know about how to manage early abnormalities, that every case is a tragedy.”

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