Jeff Andrews, MD, discusses Onclarity for HPV self-collection

At-home HPV self-collection is gaining momentum as it rolls out following its regulatory clearance, offering patients a screening option outside the clinic and allowing primary care physicians to fold cervical cancer screening into routine visits, according to Jeff Andrews, MD, FRCSC, Vice President, Medical Affairs, Waters Advanced Diagnostics.

The FDA cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping on April 8, 2026, enabling patients to collect samples at home for processing via the automated BD COR System.¹ The clearance targets a persistent gap: approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened. Full coverage of the clearance is available here.

Andrews described the shift as removing a longstanding barrier at the primary care level.

“At-home self-collection offers our patients a safe and effective choice for HPV screening outside of the clinic, and primary care doctors can now offer this option of self-collection directly during routine appointments, eliminating the need or any barriers to referring patients for a speculum exam,” he said.

He noted that forthcoming policy changes reinforce the trend.

“The HRSA guidelines announced this year go into effect on January 1, 2027, and they emphasize things like zero out-of-pocket coverage for cervical cancer screening and follow-up, as well as expanding access to include self-collection,” Andrews said, adding that primary care physicians who traditionally referred out for speculum exams can now offer self-collection during routine or problem visits, “preventing missed opportunities for patient preventive care.”

Andrews emphasized that a positive result does not automatically lead to a procedure, pointing to the assay's genotyping, which identifies 6 genotypes individually and 3 pooled groups.e

“Because of OnClarity's extended genotyping capabilities and the current US guidelines, higher-risk genotypes like 16 and 18 are referred to colposcopy. Lower-risk genotypes like 56, 59, and 66 are recommended for a retest in a year, and only the middle set of genotypes require a referral to someone for a speculum exam and traditional Pap test,” he said.

He recommended clinicians counsel patients on both the reliability of the method and the likelihood of follow-up.

“They should also inform patients there's a possibility, under 10%, of a positive HPV result that would require a follow-up speculum exam and Pap test,” Andrews said, noting other positive results could mean referral to colposcopy or a recommendation to repeat self-collection testing after a year.

Reference:

1. Fitch J. FDA clears Onclarity HPV self-collection kit, approves BD Onclarity HPV Assay for cervical cancer screening. Contemporary OB/GYN. Published April 8, 2026. Accessed August 13, 2026. https://www.contemporaryobgyn.net/view/fda-clears-onclarity-hpv-self-collection-kit-approves-bd-onclarity-hpv-assay-cervical-cancer-screening