Becton, Dickinson and Company (BD) has announced its submission of an application to the US Food and Drug Administration (FDA) for an at-home human papillomavirus (HPV) test.
This new test is said to allow individuals to collect samples by themselves using a swab, streamlining laboratory processing and detecting more high-risk HPV strains.
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The swab does not require liquids or intricate devices and can be easily mailed from home to the lab, enhancing access to cervical cancer screening programmes.
At the laboratory, self-collected swabs bypass the need for manual sample preparation by technologists.
It is processed by the BD COR System, which employs robotics for sample preparation, analysis, and result reporting. Its automation and internal cellular control decrease manual intervention, ensuring the integrity of the results.
BD noted that the BD Onclarity Assay is also capable of identifying individual high-risk HPV strains more comprehensively than any other current test.
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By GlobalDataThis feature is said to be important due to the evolving prevalence of high-risk HPV genotypes beyond types 16 and 18.
The American Society for Colposcopy and Cervical Pathology has incorporated the BD Onclarity Assay into its Enduring Risk-Based Management Guidelines earlier in 2025.
Additionally, the US Preventive Services Task Force’s draft recommendations include self-collection for HPV and cervical cancer screening.
BD diagnostic solutions president Nikos Pavlidis said: “We envision a world where women are empowered with access and a choice for their HPV screening, whether it be in a routine visit at the doctor’s office or the comfort and privacy of their own home via a self-collected sample.
“Cervical cancer and the loss of more than 4,000 women per year to this devastating disease are preventable, and we believe at-home testing is an important leap forward to our goal of eliminating this type of cancer.”
The company recently announced a trial of the BD Libertas wearable injector, aimed at the subcutaneous delivery of biologics.
