Waters Announces FDA Clearance Of Onclarity Self-Collection Kit For At-home Use

FDA cleared Waters' Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use; Waters is forming partnerships to enable nationwide access. The approval expands at-home HPV screening addressable market and is a near-term commercial catalyst for WAT that could move the stock in the ~1-3% range as adoption and distribution ramp.

Analysis

FDA cleared Waters' Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use; Waters is forming partnerships to enable nationwide access. The approval expands at-home HPV screening addressable market and is a near-term commercial catalyst for WAT that could move the stock in the ~1-3% range as adoption and distribution ramp.