{"id":46712,"date":"2024-07-24T12:00:00","date_gmt":"2024-07-24T12:00:00","guid":{"rendered":"https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2024\/fda-hpv-test-self-collection-health-care-setting"},"modified":"2024-11-03T15:11:48","modified_gmt":"2024-11-03T15:11:48","slug":"fda-approves-hpv-tests-that-allow-for-self-collection-in-a-health-care-setting","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-hpv-tests-that-allow-for-self-collection-in-a-health-care-setting\/","title":{"rendered":"FDA Approves HPV Tests That Allow for Self-Collection in a Health Care Setting"},"content":{"rendered":"

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For now, the option to self-collect a vaginal sample for HPV testing must be done in a health care setting.<\/p>\n

Credit: iStock\/SDI Productions<\/p>\n<\/p><\/div>\n<\/figcaption><\/figure>\n<\/p><\/div>\n

On May 14, the Food and Drug Administration (FDA) expanded the approvals of two tests that detect cancer-causing types of human papillomavirus (HPV) in the cervix. Both tests are used as part of screening for cervical cancer.<\/p>\n

Under these expanded approvals, people can now be offered the option to collect a vaginal sample themselves for HPV testing if they cannot have or do not want a pelvic exam<\/a>. However, the collection, which involves a swab or brush, must be done in a health care setting, such as primary care offices, urgent care, pharmacies, and mobile clinics.<\/p>\n

The tests included in the approvals are Onclarity HPV, made by Becton, Dickinson and Company (BD), and cobas HPV, made by Roche Molecular Systems.<\/p>\n

Until now, screening for cervical cancer<\/a> in the United States has required a sample of cells collected from the cervix during a pelvic exam performed by a health care professional. But the availability of a self-collection option in health care settings should help widen access to screening, said Vikrant Sahasrabuddhe, M.B.B.S., Dr. P.H., of NCI\u2019s Division of Cancer Prevention.<\/p>\n

Increased access to HPV testing is a particular need for certain populations among which rates of cervical cancer screening continue to be low<\/a>, Dr. Sahasrabuddhe said.<\/p>\n

\u201cThese [current] approvals are only a first step in what we think will be a much wider set of future approvals, once we gather additional evidence,\u201d he said.<\/p>\n

Those future approvals, he continued, will hopefully come as a result of the NCI-led “Last Mile” Initiative<\/a>. Last Mile is intended to accelerate the development and approval of self-collection approaches for HPV testing, including self-collection in people\u2019s own homes. Research supported by the initiative<\/a>, in fact, helped lead to the recent expanded approvals.<\/p>\n

As a part of Last Mile, a nationwide clinical trial program has been launched called SHIP (Self-collection for HPV testing to Improve Cervical Cancer Prevention)<\/a>. The trial will test whether self-collection in a home setting works as well as collection by a clinician in a health care setting, continued Dr. Sahasrabuddhe, who leads the Last Mile Initiative and SHIP Trial.<\/p>\n

Making home-based sample collection an option, he said, \u201cwill hopefully widen access to screening even further.\u201d<\/p>\n

Cervical cancer screening is not always accessible<\/h2>\n

Currently, almost 30% of eligible people with a cervix (women and people assigned female at birth) in the United States can’t or don’t get screened for cervical cancer at the recommended intervals<\/a>.<\/p>\n

In addition, far fewer people than recommended are getting HPV vaccines, which provide nearly 100% protection against cancer-causing types of HPV<\/a>, explained Nicolas Wentzensen, M.D., Ph.D., of NCI\u2019s Division of Cancer Epidemiology and Genetics, an expert on cervical cancer screening and management.<\/p>\n

As a result, about 11,500 people in the United States are diagnosed with cervical cancer each year. Half of all new cases are in people who were not screened or inadequately screened as recommended by current guidelines.<\/p>\n

Expert groups, including the U.S. Preventive Services Task Force, recommend that starting in their 20s, people with a cervix start getting screened for cervical cancer. (See the box.)<\/p>\n