Waters Corporation and Quest Diagnostics plan nationwide home HPV screening

A nationwide at-home cervical cancer screening rollout is planned for 2027 after Waters Corporation NYSEWAT and Quest Diagnostics NYSEDGX announced a collaboration on Tuesday. The agreement connects Waters' technology with Quest's network of more than 2,000 patient service centres and its clinician, health-plan and consumer channels.

The Oct. 20 announcement covers the FDA-cleared Onclarity Self-Collection Kit, used with the FDA-approved BD Onclarity HPV Assay. Patients will mail samples to Quest or drop them at its centres, with Quest laboratories processing them on automated BD COR systems.

Waters is a Massachusetts-based global supplier of laboratory instruments and diagnostics, while New Jersey-based Quest operates a nationwide laboratory-testing business.

Waters shares closed at US$434.27 on the NYSE at 4 p.m. EDT on Monday NYSEWAT. Quest shares closed at US$234.91 on the NYSE at 4 p.m. EDT on Monday NYSEDGX. Both closes preceded Tuesday's announcement.

Quest says it serves one in three American adults and half the country's physicians and hospitals annually. The collaboration is Waters' first spanning clinicians, health plans and consumers alongside patient service centres.

The health-plan channel will use Quest's Gaps in Care programme, while consumers will be able to initiate testing through questhealth.com. Patients collect the specimen at home, but the laboratory performs the assay.

"In the U.S., there are over 24 million un- and under-screened individuals and approximately 14,000 new cases of cervical cancer each year," Waters Advanced Diagnostics vice-president of medical affairs Jeff Andrews said in the release.

Clearance Came Before The Distribution Agreement

Waters announced the kit's FDA clearance and the assay's approval for at-home use on April 8. Tuesday's agreement expands commercialization of that previously authorized combination.

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Waters says the assay identifies six HPV types individually and reports three additional pools, providing genotype information to guide patient management. Tuesday's release describes wider distribution rather than a new clinical-performance study.

Waters' April announcement said the kit was expected to be available by prescription, with results shared with the patient's healthcare provider to guide follow-up and care decisions.

Roche Holding AG SWXROP OTCMKTSRHHBY announced FDA approval in May 2024 for self-collection in healthcare settings using its cobas HPV test. Quest introduced that option in April 2025 and specified that it was not authorized for at-home collection.

Roche's May 2024 product description says its test detects 14 high-risk HPV types. It reports HPV 16 and HPV 18 separately, pooling the remaining types.

The planned Onclarity rollout adds collection at home while retaining Quest's laboratory processing and sample-return network. The companies describe mailing specimens or dropping them at patient service centres as alternative ways to reach the testing laboratory.

The Oct. 20 rollout description gives no test price, expected testing volume or revenue projection. Its national reach establishes potential distribution scale without quantifying the contribution to either company's sales.

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Insurance Coverage Changes In 2027

The Health Resources and Services Administration's Jan. 5 update made high-risk HPV testing the preferred screening method for average-risk women aged 30 to 65, whether samples are patient- or clinician-collected. The guideline retains cervical cytology, or Pap testing, as an option.

The companies have not specified a month or day for Quest's 2027 rollout. The next fixed milestone is Jan. 1, 2027, when HRSA says most insurance plans must begin covering the updated guideline, including additional testing needed to complete screening.