Waters and Quest to launch at-home HPV test kit across the US in 2027

Waters is partnering with Quest Diagnostics to offer its BD Onclarity HPV assay as an at-home self-collection kit in the US starting early 2027. The test was cleared by the FDA for home use in April 2026 and must be ordered by a clinician; samples can be mailed back or dropped off at one of 2,000 Quest centers.

• At-home HPV test kits will reach the US market in early 2027
• BD Onclarity HPV assay was FDA-cleared for home use in April 2026
• Samples can be mailed back or dropped at one of 2,000 Quest centers
• Onclarity offers extended genotyping beyond HPV types 16 and 18