By Dennis Thompson HealthDay Reporter<\/b><\/p>\n
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WEDNESDAY, May 15, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could increase early detection in those at risk for cervical cancer<\/a>.<\/p>\n Women will be able to swab themselves in privacy at a doctor’s office, clinic or pharmacy, and the sample will then be sent off for analysis.<\/p>\n More than half of U.S. women diagnosed with cervical cancer have never been screened or screened only infrequently for the virus, the kit’s maker Roche said in a news release<\/a> announcing the approval on Wednesday.<\/p>\n With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach, Roche Diagnostics CEO Matt Sause said. Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing.<\/p>\n Each year, about 11,500 U.S. women are diagnosed with cervical cancer and about 4,000 women die from it, according to the U.S. Centers for Disease Control and Prevention.<\/p>\n HPV is the known cause of more than 95% of cervical cancers, Roche added.<\/p>\n Almost all cervical cancers are caused by persistent infection with certain types of HPV, Dr. Karen Knudsen<\/a>, CEO of the American Cancer Society (ACS), said in a statement. Self-collection can expand access to screening and reduces barriers, which will give more people the opportunity to detect, treat and ultimately survive cancer.<\/p>\n Most primary care doctors don’t test for HPV. Instead, women are most often screened by gynecologists during a pelvic exam, a procedure to which some don’t have access and others find too intrusive and embarrassing.<\/p>\n Roche’s self-collection solution can help reduce these barriers by offering an alternative to clinician collection procedures, while also providing accurate and reliable results, Roche said.<\/p>\n The HPV test itself is already covered by private insurance, Medicare and Medicaid, Roche told the Washington Post<\/em>.<\/p>\n This literally just opens up another option for a different demographic of people that might not feel comfortable, that might not have access [and] may not have time to get tested otherwise, Irene Aninye<\/a>, chief science officer for the Society for Women’s Health Research, told the Post<\/em>.<\/p>\n The ACS recommends that cervical cancer screening begin at age 25, and that women ages 25 to 65 have an HPV test every five years.<\/p>\n Studies done for the past two decades have found that self-collection for HPV testing is feasible and acceptable, and that women can collect samples as well as their physicians, the ACS said.<\/p>\n Self-collection was not FDA-approved at the time our current guideline was released, but we now expect a minor update to the guideline to note that primary HPV testing via clinician-collected sample or self-collection is acceptable, said ACS Chief Scientific Officer Dr. William Dahut<\/a>.<\/p>\n We anticipate self-collection will play an increasingly prominent role in cervical cancer screening once regulatory and clinical prerequisites are in place and as supporting evidence continues to accumulate, Dahut added.<\/p>\n The approval could also open the door for at-home collection of samples.<\/p>\n Teal Health<\/a> received FDA breakthrough designation last week for an at-home cervical cancer screening device called the Teal Wand. Women would collect their own sample at home, then send it to a lab to be tested for HPV.<\/p>\n The designation grants Teal Health priority status from regulators when clinical trials wrap up and the data is submitted to the FDA.<\/p>\n No more stirrups, no more speculum, the Teal Health website<\/a> promises. The Teal Wand replaces the need for an in-office pap smear using stirrups, a speculum and a hard plastic brush or broom. With self-collect, you are in control.<\/p>\n More information<\/strong><\/p>\n The National Cancer institute has more on cervical cancer<\/a>.<\/p>\n