Becton, Dickinson and Company (BD) has received approval from Health Canada for Onclarity HPV Assay to be used with self-collected vaginal specimens for human papillomavirus (HPV) testing at home.
This approval marks a significant advancement in making cervical cancer screening more accessible and less invasive compared to traditional methods.
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Self-collection offers an alternative to the Pap test usually performed by clinicians, potentially increasing screening rates among populations that face barriers to traditional healthcare settings.
The BD Onclarity HPV Assay enables women to collect samples themselves, which can be particularly beneficial for those living in remote or rural areas.
BD Canada president Ivy Parks said: “Self-collection is a game-changer for health equity, as it removes the logistical, financial and psychological barriers many women face when accessing traditional screening methods.
“By providing a convenient and reliable option for HPV testing at home, we are not only improving access to care but also empowering women to take proactive steps in managing their health. This innovation is a testament to BD’s dedication to breaking down barriers and ensuring all women, regardless of their circumstances, have the opportunity to protect themselves from cervical cancer.”
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By GlobalDataThe self-collected HPV testing method is not only less invasive but also cost-effective than the traditional Pap test.
It requires less frequent testing, with current recommendations suggesting a five-year interval between tests. This could lead to increased compliance and better long-term health outcomes for women across Canada.
The accuracy of the BD Onclarity HPV Assay matches that of clinician-collected samples, ensuring reliable results for detecting HPV, which is linked to approximately 70% of cervical cancer cases in Canada.
With around 16.3 million Canadian women aged 15 years and older at risk, the adoption of primary HPV screening is a critical step recommended by the Canadian Partnership Against Cancer.
The assay stands out as it is the only test licensed by Health Canada that supports self-collection and offers extended genotyping.
This feature allows for a more precise assessment of a woman’s risk for developing cervical pre-cancer and cancer.
The approval aligns with Canada’s goal of eliminating cervical cancer by 2040.
In February 2023, BD received market approval from the US Food and Drug Administration (FDA) for its Onclarity HPV Assay for use with the ThinPrep Pap Test.
