Assessing Onclarity HPV assay safety and efficacy for cervical cancer screening


A recent study evaluated the safety and effectiveness of the Onclarity HPV assay in detecting high-grade cervical disease, presenting findings on its comparability to predicate assays and potential for cost-saving benefits in screening practices.

Assessing Onclarity HPV assay safety and efficacy for cervical cancer screening | Image Credit: © Saiful52 - © Saiful52 -

Assessing Onclarity HPV assay safety and efficacy for cervical cancer screening | Image Credit: © Saiful52 - © Saiful52 -

The Onclarity HPV assay (Becton, Dickinson and Company, BD Life Sciences - Integrated Diagnostic Solutions, Sparks, MD) is safe and effective for use in human papillomavirus (HPV) testing, according to a recent study published in the American Journal of Obstetrics and Gynecology.


  1. The Onclarity HPV assay, as indicated in a recent study, demonstrates safety and efficacy in detecting high-grade cervical disease, presenting a promising option for cervical cancer screening.
  2. Comparisons with predicate assays reveal similar performance metrics, suggesting reliability and consistency in results between different testing methods.
  3. Utilization of the Onclarity assay potentially offers cost-saving benefits, particularly in light of its FDA approval for primary HPV screening.
  4. The study underscores the importance of standardized screening protocols and the need for comprehensive evaluation of HPV testing methods in diverse clinical settings.
  5. Positive agreement rates for HPV detection, particularly for HPV16 and HPV18, highlight the assay's effectiveness in identifying high-risk HPV genotypes associated with cervical cancer.

Of over 200 known HPV genotypes, approximately 40 infect the cervical mucosa and 13 to 14 are associated with high cervical precancer and cancer risks. High-grade cervical disease and cancer risks are increased by 1 year or longer of genotype-specific persistent HPV infection.

Different countries have varied approaches to cervical cancer screening, liquid-based cytology (LBC) media types, HPV test type, and national screening recommendations. Cervical precancer, such as cervical intraepithelial neoplasia grades 2 or greater (≥CIN2) and 3 or greater (≥CIN3), can be detected with increased sensitivity through HPV testing.

Co-testing is associated with increased cost without significant added insurance of increased protection vs HPV primary screening. However, the FDA has approved the Onclarity HPV assay for HPV primary screening.

While the Onclarity HPV assay has been indicated safe and effective, there is little data evaluating this index HPV assay’s use with PreservCyt Cyt (Hologic, Inc, San Diego, CA) LBC in the United States. Investigators conducted a retrospective evaluation using deidentified cervical specimens collected in PreservCyt.

Women aged 21 to 65 receiving cervical cytology alone or co-testing screening from August 2013 to October 2016 were included in the analysis. Testing with the index and predicate HPV assays was performed for deidentified PreservCyt specimens selected from residual PreservCyt specimens.

During routine clinical practice, historical, baseline, and follow-up data for HPV tests, cervical cytology, hysterectomies, and cervical biopsies were reported. Investigators reviewed all cervical pathology within 5 years of enrollment, but only counted the first worse diagnosis.

Patients with atypical squamous cells of undetermined significance or negative for intraepithelial lesion or malignancy (NILM) baseline cytology received cervical biopsy during follow-up. Patients with low-grade squamous intraepithelial lesion (LSIL) or greater at baseline were recommended cervical biopsy during follow-up.

A negative status was given to patients with no endocervical curettages (ECCs) or cervical biopsy during follow-up and those with an NILM cytology result and negative or unavailable HPV result. Patients with hysterectomy before enrollment or cervical cytology, HPV testing, or cervical biopsy within 300 days before enrollment were excluded from the analysis.

Routine clinical practice was followed to determine cervical screening results, while community diagnoses of cervical biopsies, excisional biopsies, ECC, and hysterectomy were used to determine histologic outcomes. Categories included less than CIN2 (<CIN2), CIN2, CIN3, and cancer.

A positive index assay result for ≥CIN3 had a verification bias adjustment (VBA) rate of 5.6%, vs 4.6% for a positive predicate assay result. These rates were 12.2% and 10.1%, respectively, for ≥CIN2. The index assay and predictive assay had under 1-year VBA positivity rates of 95.2% and 94.5%, respectively, for ≥CIN3 and 92.2% and 93.2%, respectively, for ≥CIN2.

This data indicated similar results between the 2 assays. The 5-year cumulative ≥CIN3 and ≥CIN2 positivity rates were also similar between the assays. For 5-year <CIN2, positivity rates of 12.2% for the index assay and 14.8% for the predictive assay were reported.

The assays had positive agreement rates of 97.8% for any HPV, 100% for HPV16, and 90.9% for HPV18. Negative agreement rates for these HPV types were 88.9%, 98.7%, and 100%, respectively. Similar results were reported for ≥CIN2 agreement rates.

These results indicated safety and efficacy from utilization of the index HPV assay to detect ≥CIN2 and ≥CIN3 in PreservCyt. Investigators concluded cost saving and health benefits can be reached through the FDA’s approval of the index assay.


Wheeler CM, Torrez-Martinez NE, Torres-Chavolla E, et al. Comparing the performance of 2 human papillomavirus assays for a new use indication: a real-world evidence-based evaluation in the United States. Am J Obstet Gynecol. 2024;230:243.e1-11. doi:10.1016/j.ajog.2023.09.100

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