FDA Approval of Self-Collected Vaginal Samples: A Revolutionary Step in Cervical Cancer Screening

The FDA has approved a new method that allows vaginal samples to be self-collected for cervical cancer screening without the use of traditional speculum. Biotechnology company Roche and medical technology firm Becton, Dickinson and Company (BD) announced that the FDA has approved the use of self-collected samples with their own HPV tests.

The FDA has approved a new method that allows vaginal samples to be self-collected for cervical cancer screening without the use of traditional speculum. Biotechnology company Roche and medical technology firm Becton, Dickinson and Company (BD) announced that the FDA has approved the use of self-collected samples with their own HPV tests.

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

"Almost all cervical cancers are linked to persistent infection with certain HPV types," said Dr. Karen E. Knudsen, CEO of the American Cancer Society, in a statement on Wednesday. "Self-collection of samples may expand screening access and reduce barriers, enabling more people to detect, treat, and ultimately survive cancer."

Typically, gynecologists collect samples for HPV tests or perform cervical cytology, also known as Pap smear, or both. The U.S. Preventive Services Task Force recommends cervical cancer screening with cervical cytology every three years for women aged 21 to 29 and either cervical cytology alone every three years, high-risk HPV testing alone every five years, or high-risk HPV testing with cytology every five years for women aged 30 to 65.

However, for some patients, having samples taken for these tests by a healthcare professional can be uncomfortable or awkward.

"Most patients are uncomfortable with the intimate nature of pelvic exams," said Dr. Jeff Andrews, Vice President of Global Medical Affairs for Diagnostic Solutions at BD, in the company's announcement on Wednesday.

"Additionally, many people live in areas where there may not be a local doctor or healthcare professional trained to take samples with a speculum," he said. "The option to self-collect samples in a clinical setting may help overcome some of these barriers."

The BD Onclarity HPV Test is now FDA-approved for self-collected samples that do not require a traditional Pap smear. BD is expected to enroll in a trial this summer for self-collection of samples for an HPV test, in collaboration with the National Cancer Institute. BD is participating in a trial starting this summer to assess the accuracy of self-collection both in healthcare settings and at home.

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

In the U.S., more than 11,000 cases of cervical cancer are diagnosed each year, and approximately 4,000 women die from the disease, according to the Centers for Disease Control and Prevention (CDC). It is estimated that about half of invasive cervical cancer cases are diagnosed in individuals who have never been screened, and 10% of cases are diagnosed in individuals who have not had a Pap smear in the past five years.

"Despite the benefits of cervical cancer screening, not all women and individuals with a cervix are screened regularly," said Dr. William Dahut, Chief Medical Officer of the American Cancer Society, in a statement on Wednesday.

"Most cases of cervical cancer are found in individuals who have never had a cervical cancer screening test or have not had one recently. Therefore, adding self-collection in a clinical setting as a screening method for this potentially deadly disease could have a significant impact," he added. "When regulatory and clinical requirements are met and supportive evidence continues to accumulate, FDA may consider approving self-collection method not only in a healthcare setting but also at home."

FDA may consider approving self-collection method not only in a healthcare setting but also at home. Teal Health developed Teal Wand, a home cervical cancer screening device, which was granted "innovative device" status by the FDA this month.

"FDA's recognition of Teal Wand as an Innovative device acknowledges the significant public health benefit it offers to individuals rarely screened or not participating in clinician-based screening for self-cervical cancer screening," said Trena Depel, Vice President of Clinical and Regulatory Affairs at Teal Health, in a press release at the time.

Cervical cancer screening remains important as early cases often do not show symptoms. Advanced cases can cause abnormal vaginal bleeding or unusual discharge. Cervical cancer can be treated in various ways, including surgery, chemotherapy, and radiation therapy.

According to the CDC, some of the most important steps women can take to prevent cervical cancer include getting vaccinated against HPV, not smoking, using condoms during sexual intercourse, getting regular screening tests, and returning to the doctor if screening test results are abnormal.