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

CNN
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Instead of a traditional speculum pelvic exam to screen for cervical cancer, the U.S. Food and Drug Administration has given patients the green light to have the option to collect their own vaginal samples for screening in a healthcare setting, such as at their doctor’s office, emergency department or even a mobile clinic.

Two health care companies — biotechnology company Roche and medical technology company Becton, Dickson and Company, or BD — announced Wednesday that the FDA has approved the use of self-collected samples with their respective HPV tests.

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

“Nearly all cervical cancers are caused by persistent infection with certain types of HPV,” Dr. Karen E. Knudsen, CEO of the American Cancer Society, said in a statement Wednesday. “Self-collection can expand access to screening and reduce barriers, giving more people the opportunity to detect, treat and ultimately survive cancer.” »

Typically, gynecologists collect samples for HPV testing, cervical cytology, or both. Cervical cytology, also known as a Pap smear or Pap smear, involves examining cervical cells for changes to detect precancerous or cancerous cells.

The U.S. Preventive Services Task Force recommends cervical cancer screening with cervical cytology every three years for women ages 21 to 29. For women ages 30 to 65, the USPSTF recommends screening every three years with cervical cytology alone, every five years for high-risk women. HPV testing alone, or every five years with high-risk HPV testing in combination with cytology.

But for some patients, asking a provider to collect a sample for these tests can be painful or inconvenient.

“Many patients are uncomfortable with the intimate nature of a pelvic exam,” said Dr. Jeff Andrews, board-certified gynecologist and vice president of global medical affairs for diagnostic solutions at BD, in company announcement Wednesday.

“In addition, many people live in areas without a local doctor or clinician trained to collect a sample with a speculum,” he said. “The ability to self-collect in a clinical setting may help women overcome some of these barriers. »

The BD Onclarity HPV Test is now FDA approved for HPV testing on self-collected samples without the need for a traditional Pap test, according to the company’s announcement Wednesday. A self-collection trial for HPV testing, in which BD is participating with the National Cancer Institute, is expected to begin recruiting this summer, the company said, to evaluate the accuracy of self-collection for HPV testing in health care and in other contexts. including at home.

Roche announced that HPV self-collection is approved for use with the company’s cobas HPV test, and that the company has also collaborated with the National Cancer Institute.

Each year in the United States, more than 11,000 cases of cervical cancer are diagnosed and about 4,000 women die from the disease, according to the U.S. Centers for Disease Control and Prevention. It is estimated that about half of cases of invasive cervical cancer are diagnosed in people who have never been screened and about 10% of diagnoses are in people who have not had a test Pap in the previous five years.

“Despite the benefits of cervical cancer screening, not all women and people with cervixes are screened regularly,” Dr. William Dahut, scientific director of the American Cancer Society, in a press release.

“Most cervical cancers occur in people who have never had a cervical cancer screening test or who have not had one recently. This is why adding self-sampling at a health center as a screening method for this potentially deadly disease can have a huge impact,” he added. “We anticipate that self-collection in a health care setting will play an increasingly important role in cervical cancer screening once regulatory and clinical conditions are in place and evidence in support will continue to accumulate. »

Next, the FDA might consider allowing the self-collection method at home rather than just at a health care facility. Teal Health has developed an at-home cervical cancer screening device called Teal Wand that was granted “breakthrough device” status by the FDA this month, which would allow the agency to review the device in a faster time.

“The FDA’s recognition of the Teal Wand as a breakthrough device recognizes the significant public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinical screening for cervical cancer,” Trena Depel, vice president of clinical and regulatory services at Teal Health, said in a press release at the time.

Screening for cervical cancer remains important because early cases often have no signs or symptoms. Advanced cases may cause abnormal vaginal bleeding or unusual discharge. Cervical cancer is treated in several ways, including surgery, chemotherapy, and radiation therapy.

According to the CDC, some of the most important steps women can take to prevent cervical cancer are getting the HPV vaccine, not smoking, using condoms during sex, get regular screening tests and return to the doctor if their screening test was done. the results are not normal.