Compare all HPV tests approved in the US

An overview of FDA-approved HPV assays^1-7

Test	BD Onclarity™ HPV Assay	QIAGEN digene^® HC2 High-Risk HPV DNA Test	HOLOGIC Aptima™ HPV Assay	HOLOGIC Cervista™ HPV HR	ROCHE cobas^® HPV for 4800 System	ROCHE cobas^® HPV for 6800/8800 Systems
Approved for HPV primary screening
Separate results for HPV 16 and 18			Separate assay run^a	Separate assay run^b
Genotyping beyond HPV 16 and 18	16, 18, 31, 45, 51, 52		18/45 combined^a
Internal control for human genes
PCR-based DNA assay		DNA, non-PCR	RNA, non-PCR	DNA, non-PCR
No cross-reactivity with low-risk HPV genotypes
E6/E7 target region
Manufacturer offers full cervical screening solution	Cytology and HPV	HPV only	Cytology and HPV	HPV only	Cytology and HPV	Cytology and HPV
Clinical trial	Onclarity trial	ASC-US/LSIL Triage Study (ALTS)	CLEAR trial	Cervista HPV HR trial	ATHENA trial	IMPACT trial

^a A separate test can be used to identify HPV 16 and 18/45 in women with positive results.
^b A separate test can be used to identify HPV 16 and 18 in women with positive results.

BD Onclarity™ HPV Assay

*As compared to other FDA-approved HPV tests.

ASC-US, atypical squamous cells of undetermined significance; HC2, Hybrid Capture 2; HPV, human papillomavirus; HR, high risk; NILM, negative for intraepithelial neoplasia grade 1.

1. Stoler MH et al. Gynecol Oncol. 2018;149(3):498–505.
2. Wright TC et al. Am J Clin Pathol. 2019;151(1):53–62.
3. BD Onclarity™ HPV Assay US Package Insert [8089894].
4. Stoler MH et al. Am J Clin Pathol. 2019;151(4):433–42.
5. Salazar K et al. J Am Soc Cytopath. 2019;8:284–92.
6. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
7. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–7.
8. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.
9. Bodily J and Laimins LA. Trends Microbiol. 2011;19(1):33–9.
10. Bottari F et al. J Clin Microbiol. 2015;53:2109–14.

Compare FDA-approved HPV assays