BD Onclarity™ HPV Assay
Extend the power of HPV testing
Cervical cancer is the 4th most frequent cancer in women1
While preventable, cervical cancer takes a heavy toll.
The high mortality rate from cervical cancer globally, could be reduced through a comprehensive approach that includes prevention through vaccination, early diagnosis, effective screening and treatment programs.1
*BD Onclarity™ HPV Assay detects the 14 high-risk HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 classified as carcinogenic, 68 classified as probably carcinogenic, and 66 classified as possibly carcinogenic to humans.5,6
HPV infection is a well-established cause of cervical cancer.1
HPV testing is a valuable tool in the fight against cervical cancer
- Identify HPV types that cause cervical cancer and pre-cancer7-9
- Predict the immediate and future risk of disease10,11
- Determine the risk of adenocarcinoma8
- Track persistence of genotype-specific HPV infection12
- Monitor the impact of HPV vaccination
IDENTIFYING INDIVIDUAL HPV GENOTYPES ENABLES HEALTH CARE PROFESSIONALS TO MORE PRECISELY IDENTIFY THE RISK FOR DEVELOPING CERVICAL DISEASE.
†The 14 high-risk HPV types are 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 classified as carcinogenic, 68 classified as probably carcinogenic and 66 classified as possibly carcinogenic to humans.6
Learn moreClinical value of extended genotyping
The 14 high-risk HPV types have very different potential to cause cervical cancer. Some HPV types are more prevalent while others that are less common, are linked to a higher risk of cancer.
Risk profile of different HPV types
The 9-valent HPV vaccine (9vHPV) targets HPV types 6, 11, 16, and 18 (targeted by the quadrivalent HPV vaccine (4vHPV)), as well as five additional types, HPV types 31, 33, 45, 52, and 58.
High risk of disease
HPV 16, 18, 45
70% of all cervical cancers7,8 94% of adenocarcinomas7
Moderate risk of disease
HPV 31, 33, 58 52
20% of all cervical cancers7,8
Lower risk of disease
HPV 51, 35, 39, 68, 56, 59, 66
Learn moreBD Onclarity™ HPV Assay
Women with persistent genotype-specific infection have a higher risk of developing a cervical cancer.12
a ≥CIN2 disease12
a ≥CIN2 disease12
MONITORING GENOTYPE-SPECIFIC PERSISTENT INFECTIONS IS KEY TO IDENTIFYING YOUR PATIENTS WHO ARE AT MOST RISK FOR DEVELOPING CERVICAL DISEASE.12
Pap screening has dramatically reduced the incidence of squamous cell cancers but not the incidence of adenocarcinomas.13,14
Adenocarcinomas represent as much as 30% of all cervical cancers in many countries.14
Squamous cell cancers
Adenocarcinomas are poorly diagnosed by cytology because they do not reach the superficial part of the gland and do not shed exfoliative cells.14-16
Delays in diagnosis could be responsible for the poorer prognosis associated with these cancers.14
THE BD ONCLARITY™ HPV ASSAY CAN HELP DETERMINE THE RISK FOR ADENOCARCINOMA USING EXTENDED GENOTYPING.5,8
Learn moreThe challenge of adenocarcinomas
- 4vHPV, quadrivalent HPV vaccine;
- 9vHPV, nonavalent HPV vaccine;
- ASCCP, American Society for Colposcopy and Cervical Pathology;
- CIN, cervical intraepithelial neoplasia;
- CIN1, cervical intraepithelial neoplasia grade 1;
- CIN2, cervical intraepithelial neoplasia grade 2;
- CIN3, cervical intraepithelial neoplasia grade 3;
- FDA, Food and Drug Administration;
- HPV, human papillomavirus;
- hrHPV, high-risk human papillomavirus;
- PCR, polymerase chain reaction.
- World Health Organization. Human papillomavirus (HPV) and cervical cancer. Available at: https://www.who.int/news-room/fact-sheets/detail/human-papillomavirus-(hpv)-and-cervical-cancer. Last updated 11 November 2020. Accessed 9 June 2021.
- Saslow D et al. CA Cancer J Clin. 2012;62(3):147-172.
- European Commission. European guidelines for quality assurance in cervical cancer screening - Second Edition, Supplements. 2015.
- Huh WK et al. J Lower Gen Tract Dis. 2015;19(2):91-96.
- BD Onclarity™ HPV Assay European Product information, 8089899(14). Updated November 2020.
- IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. IARC Monogr Eval Carcinog Risks Hum. 2012;100(B):1-441.
- Li N et al. Int J Cancer. 2011;128:927-935.
- de Sanjose S et al. Lancet Oncol. 2010;11:1048-1056.
- Bottari F et al. J Clin Microbiol. 2015;53:2109-2114.
- Stoler MH et al. Gynecol Oncol. 2019,153(1):26-33.
- Schiffman M et al. Int J Cancer. 2016;139(11):2606-2615.
- Elfgren K et al. Am J Obstet Gynecol 2017;216(3):264.e1-7.
- Adegoke O et al. J Womens Health. 2012;21(10):1031-1037.
- Kyrgiou M et al. Br J Cancer. 2020;123(4):510-517.
- Katki HA et al. Lancet Oncol. 2011;12(7):663-672.
- Vaughan LM and Malinowski DP. Rev Bras Ginecol Obstet. 2019;41(5):357-359.
About 6 in every 10 women who undergo colposcopy have abnormal cells in their cervix - known as cervical intra-epithelial neoplasia (CIN).
A biopsy can help determine the risk that these cells have to become cancerous, according to the type of result:
≥CIN2, also called high-grade CIN, collectively refers to CIN2 or CIN3.
1. NHS. Colposcopy. Available at: https://www.nhs.uk/conditions/colposcopy/results. Accessed 4 September 2020.