Everlywell and Waters Corporation have launched the FDA‑cleared Onclarity HPV Self‑Collection Kit for at‑home cervical cancer screening, with samples processed using the BD Onclarity HPV Assay in CLIA‑certified labs. Results are delivered via Everlywell’s platform, with telehealth follow‑up and referrals for abnormal findings. The initiative targets health‑plan members overdue for screening and aims to help plans close CCS‑E care gaps ahead of NCQA MY2026 and 2027 federal guidance.
Everlywell and Waters Launch FDA‑Cleared At‑Home HPV Self‑Collection to Boost Cervical Cancer Screening
The BD Onclarity HPV Assay identifies six individual genotypes and three groups of pooled results. Credit: faniadiana24 / Shutterstock.com.
Everlywell has partnered with Waters Corporation to offer the FDA‑cleared Onclarity HPV Self‑Collection Kit for at‑home cervical cancer screening. Samples are collected by users at home and processed using the BD Onclarity HPV Assay in Clinical Laboratory Improvement Amendments (CLIA)‑certified laboratories.
How the Service Works
Members receive a self‑collection kit, collect a cervical sample at home, and return it to a CLIA‑certified lab for analysis. Results are delivered through the Everlywell digital platform, and telehealth visits are available for clinical follow‑up. Individuals with abnormal results can be referred for in‑person assessment and additional care.
Why This Matters
The program is designed to help health plans increase screening rates—especially among members who are overdue for recommended cervical cancer testing—and to close care gaps tied to the Cervical Cancer Screening–Electronic Clinical Data Systems (CCS‑E) quality measure. Everlywell says the offering is among the first FDA‑cleared at‑home HPV testing options positioned to respond to the National Committee for Quality Assurance Measurement Year 2026 (NCQA MY2026) updates and to help plans prepare for updated federal preventive‑services guidance due to take effect in 2027.
“Every woman deserves a clear and accessible path to understand her health and take the next right step,” said Everlywell founder and CEO Julia Cheek. “This partnership expands access to screening and connects people to appropriate follow‑up care.”
Test Details and Additional Services
The BD Onclarity assay detects 14 high‑risk HPV genotypes and can report six individual genotypes plus three pooled genotype groups. Beyond HPV screening, Everlywell also offers a range of at‑home tests and virtual care services covering cancer screening, cardiometabolic health, fertility, hormone panels, sexual health and thyroid biomarkers.
Bottom line: The Everlywell–Waters collaboration aims to make cervical cancer screening more accessible, simplify linkage to care, and support health plans in improving CCS‑E performance ahead of upcoming quality and preventive care updates.
Help us improve.
