The U.S. Food and Drug Administration (FDA) has officially approved the Onclarity HPV Self-Collection Kit for home use, produced by the American company Waters Corporation, along with the expanded genotyping test, the BD Onclarity HPV Assay. This decision aims to increase access to screening and strengthen patient-centered approaches. This is particularly significant given that approximately 60% of cervical cancer cases occur in individuals who have never been screened or are underscreened.
Cervical cancer is largely preventable through regular screening, vaccination, and early diagnosis. The primary etiological factor of the disease is the Human Papillomavirus (HPV), with high-risk oncogenic genotypes responsible for over 90% of cases.
The Onclarity HPV Self-Collection Kit is validated for use in combination with the BD Onclarity HPV Assay, which can detect all high-risk oncogenic genotypes of HPV. This assay is the only FDA-approved molecular test with expanded genotyping capabilities: the system individually identifies six high-risk genotypes and provides pooled results for three additional genotypic groups. Given these features, it is considered one of the most comprehensive HPV screening tools available.
“Expanding access to screening is a critical step toward cervical cancer prevention, and the introduction of self-collection significantly simplifies this process. As a practicing obstetrician-gynecologist who has implemented screening programs for decades, I have personally observed how fundamentally important early diagnosis is for patients. The more patients have the opportunity to be screened, the more promptly we doctors can identify risks and effectively manage cases. This allows us to direct fewer resources toward finding patients missed by screening programs and focus more on prevention, timely intervention, and treatment for those who need it most,” said Jeff Andrews, MD, FRCSC, Vice President of Medical Affairs at Waters Advanced Diagnostics.
Samples collected independently by patients are sent to a laboratory, where they are processed using a high-tech automated platform — the BD COR™ System. The system utilizes advanced robotic technologies for sample preparation, analysis, and reporting, ensuring sample integrity and high-quality, reliable results.
Waters Corporation collaborated closely with the National Cancer Institute as part of the “Cervical Cancer ‘Last Mile’ Initiative” and additionally conducted the SHIP study to evaluate the accuracy and clinical efficacy of the self-collection method.
Currently, the company is in negotiations to ensure broad availability of the Onclarity HPV Self-Collection Kit across the United States. The kit is expected to become available by prescription in the coming months. It can be sent directly to the patient’s home address, allowing them to collect a sample at a convenient time and mail it to the lab. The results will be sent directly to the patient’s healthcare provider, facilitating timely clinical decision-making.
