In a significant development, the US Food and Drug Administration (FDA) has given the green light for patients to collect their own vaginal samples for cervical cancer screening. This new approach eliminates the need for a traditional speculum-involved pelvic exam and offers the option of self-collection in healthcare settings such as doctor's offices, urgent care facilities, or mobile clinics.

Biotechnology company Roche and medical technology firm Becton, Dickson and Company (BD) announced on Wednesday that the FDA has approved the use of self-collected samples with their respective HPV tests. The majority of cervical cancers are caused by human papillomavirus (HPV), making HPV testing a crucial method to identify women at risk of developing cervical cancer.

Dr. Karen E. Knudsen, CEO of the American Cancer Society, emphasized the significance of self-collection, stating that it can expand access to screening, reduce barriers, and ultimately save lives. The current practice involves gynecologists collecting samples for HPV testing or cervical cytology (Pap test) to detect precancerous or cancerous cells.

The US Preventive Services Task Force recommends different screening frequencies based on age. Women aged 21 to 29 are advised to undergo cervical cytology every three years, while those aged 30 to 65 can choose between cervical cytology alone every three years, high-risk HPV testing alone every five years, or high-risk HPV testing combined with cytology every five years.

However, for some patients, the discomfort or awkwardness of having a provider collect a sample can be a barrier to regular screening. Dr. Jeff Andrews, VP of global medical affairs for diagnostic solutions at BD, highlighted the importance of self-collection in overcoming these barriers, particularly for patients who live in areas without access to medical professionals trained in sample collection.

BD's Onclarity HPV Assay has now been FDA-approved for HPV testing on self-collected samples, eliminating the need for a traditional Pap test. Furthermore, BD is participating in a trial with the National Cancer Institute to evaluate the accuracy of self-collection for HPV testing in various healthcare settings, including at home.

Roche also announced that self-collection is approved for use with their cobas HPV test, and they have collaborated with the National Cancer Institute in this regard.

According to the US Centers for Disease Control and Prevention, over 11,000 cases of cervical cancer are diagnosed each year in the United States, leading to approximately 4,000 deaths. Alarmingly, about half of invasive cases are detected in individuals who have never been screened, and 10% of diagnoses occur in those who have not had a Pap test in the previous five years.

Dr. William Dahut, chief scientific officer at the American Cancer Society, emphasized the need for regular screening and the potential impact of self-collection in a healthcare setting to reach individuals who are rarely screened or do not participate in clinician-based screening.

Looking ahead, the FDA is considering approving self-collection for at-home use in addition to healthcare settings. Teal Health has developed a home cervical cancer screening device called the Teal Wand, which has been granted "breakthrough device" status by the FDA, allowing for faster regulatory review.

Screening for cervical cancer remains crucial as early cases often lack noticeable symptoms. Treatment options include surgery, chemotherapy, and radiation therapy. To prevent cervical cancer, the CDC recommends getting vaccinated against HPV, avoiding smoking, practicing safe sex with condom use, regular screening tests, and following up with a doctor if the screening results are abnormal.

The FDA's approval of self-collection for cervical cancer screening marks a significant step forward in expanding access and reducing barriers to early detection and treatment, potentially saving more lives from this deadly disease.