FDA greenlights self-collection of vaginal samples for cervical cancer screening

Instead of a traditional speculum-involved pelvic exam to screen for cervical cancer, the US Food and Drug Administration has given the go-ahead for patients to have the option to collect their own vaginal samples for screening in a health care setting, such as at their doctor’s office, an urgent care or even a mobile clinic.

Two health care businesses announced that the FDA approved the use of self-collected samples with their respective HPV tests.

Most cervical cancers are caused by human papillomavirus or HPV, and screening for HPV can help identify women who may be at risk of developing cervical cancer.

Typically, gynecologists collect samples for HPV testing, a cervical cytology or both.

The US Preventive Services Task Force recommends various screening options for cervical cancer based on age.

The option for self-collection in a clinical setting can help women overcome barriers and expand access to screening.

The BD Onclarity HPV Assay and Roche’s cobas HPV test are now FDA-approved for HPV testing on self-collected samples without the need for a traditional Pap test.

Each year in the United States, thousands of cases of cervical cancer are diagnosed and a significant number of women die from the disease.

Adding self-collection in a health-care center as a screening method for cervical cancer can make a huge impact in detecting the disease early.

The FDA could potentially greenlight the self-collection method at home in the future.

Screening for cervical cancer remains important because early cases often may not have signs or symptoms.

Women can take preventive measures such as vaccination against HPV, not smoking, using condoms during sex, and having regular screening tests.