Waters Corporation (NYSE:WAT) reached a significant regulatory milestone on April 8, 2026, with the U.S. Food and Drug Administration granting clearance for the Onclarity HPV Self-Collection Kit and approval for the associated assay for at-home use.
The regulatory green light covers the Onclarity HPV Assay, a diagnostic tool designed to provide extended genotyping by identifying six individual high-risk HPV types and three pooled groups.
The system is engineered to work in tandem with the automated BD COR System, allowing for high-throughput processing and standardized results in clinical laboratory settings.
The introduction of the self-collection kit is strategically aimed at addressing a major gap in preventative healthcare.
According to clinical data, approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened.
By allowing patients to collect samples in a private setting rather than a traditional clinical environment, Waters expects to lower the barriers to entry for critical diagnostic testing.
The kit will be made available via prescription in the coming months.
Waters confirmed that the diagnostic process will be eligible for coverage under private insurance plans as well as government-funded programs, including Medicaid and Medicare.