Waters Acquires BD Diagnostics, Secures At-Home Cervical Cancer Screening Lead

  • Waters Corporation (WAT) has completed the acquisition of BD Biosciences and BD Diagnostic Solutions from Becton, Dickinson and Company.
  • The FDA has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay for at-home use, expanding access to cervical cancer screening.
  • The BD Onclarity HPV Assay is the most comprehensive HPV screening tool in the U.S., detecting six individual and three pooled HPV genotypes.
  • The kit utilizes the fully automated BD COR™ System for sample processing and analysis.
  • Waters is establishing partnerships to broaden access to the self-collection kit, expected to be available by prescription in the coming months and covered by major insurance providers.

This acquisition positions Waters as a significant player in the rapidly expanding at-home diagnostics market, addressing a critical need for improved cervical cancer screening access. The FDA clearance validates the efficacy of the self-collection method, which has been identified as a key strategy to address the 60% of unscreened or under-screened individuals. The deal represents a strategic shift for Waters, expanding its portfolio beyond analytical technologies into direct patient care solutions.

Integration Risk
The success of Waters’ acquisition hinges on the seamless integration of BD’s diagnostics businesses, which could face operational and cultural challenges.
Adoption Rate
The pace at which healthcare providers and patients adopt the at-home self-collection kit will determine the financial impact on Waters and its ability to significantly reduce cervical cancer screening gaps.
Reimbursement
Continued coverage by private insurance, Medicaid, and Medicare will be crucial for sustained demand and market penetration of the Onclarity kit.