Waters, a laboratory equipment manufacturer, announced on Wednesday that the US Food and Drug Administration has approved its at-home cervical cancer screening kit for use with an authorized HPV test. This approval could significantly improve early detection and help lower cervical cancer mortality rates.
Following the announcement, Waters’ shares rose approximately 4% in early trading. The company highlighted that nearly 60 percent of cervical cancer cases occur in individuals who are either unscreened or inadequately screened. Public health experts have emphasized that expanding screening options, including self-collection at home, is a crucial strategy for enhancing early diagnosis and reducing deaths from cervical cancer.
The self-collection kit, which has been validated with BD’s Onclarity HPV assay, is designed to identify all high-risk strains of human papillomavirus. Patients can collect their own samples at home and send them to a laboratory for analysis. The results are then communicated to their healthcare providers.
the World Health Organization, persistent HPV infection of the cervix, if left untreated, is responsible for approximately 95% of cervical cancer cases. Waters collaborated with the US National Cancer Institute to verify the accuracy of the home sample collection method.
In a significant development, Waters is establishing partnerships to distribute the kit nationwide by prescription within the coming months. The company expects the screening kit to be covered by private insurance plans as well as federal programs such as Medicare and Medicaid.
