FDA Greenlights Self-Sampling Method for Detecting Cervical Cancer Caused by HPV

The FDA’s recent approval of 2 self-sampling diagnostic devices is a great leap forward in cervical cancer screening, which gives women a chance to collect a sample for testing by themselves. This tool helps detect many of the early and potentially preventable cases of cervical cancer without a woman undergoing an invasive gynecological examination.

These separate self-collections will be provided by BD and Roche, although it is not approved for use in the healthcare setting alone. Nevertheless, the approval of these two companies is expected to provide an expansion when it comes to access to screening as it will enable people to undergo HPV testing in various locations such as retail pharmacies or mobile clinics.

HPV is almost the cause of all cervical cancers in the world. Stirrups and specula were commonly used by physicians, as the traditional Pap test method aimed at detecting signs of contamination. But Jeff Andrews, VP of global medical affairs diagnostics at BD, and a board-certified gynecologist pointed out that the vast majority of people go through uncomfortable feelings during pelvic exams. Additionally, people may live in places without any sexually transmitted disease component in the local healthcare providers’ training. Consequently, self-collection service in a clinical setting might provide a solution to better the situation.

BD’s Onclarity HPV test received the green light for primary testing and a cervical screening without a conventional pap smear. Roche Diagnostics CEO Matt Sause highlights the difference it will make in meeting the World Health Organisation’s vision of ending cervical cancer as a global health threat by 2030. He further argues that by way of the HPV self-collection method, patients can have better HPV screening test access through the private sample collection.

American Cancer Society and the NIH’s statistics from the National Cancer Institute stress the advantages of routine screening. About half of the new cervical cancer patients are those who have never been screened and about 10% are the ones who have been tested less often than recommended. Moreover, 25% of women in the U. S. do not undergo regular screening.

Roche and BD involved themselves in the NCI’s “Last Mile” program, which aimed at the creation of precise, self-collected HPV tests. It is mostly preventable and treatable when detected early. BD expects a remarkable increase in screening rates after implementing self-collection, especially among Black, Hispanic, and American Indian women who have higher rates of cervical cancer. Women frequently do not want or are not able to go through traditional pelvic exams due to problems with access and fear related to sexual, physical, or mental abuse.

In addition to BD and Roche, the San Francisco-based Teal Health is one more startup that is working on self-collection hardware for cervical cancer screening. Teal Health’s at-home wand device has just received a breakthrough designation from the FDA. In a clinical trial with 215 participants, the self-collection was very welcome and the majority of the women preferred it rather than the one they are used to now.