Xpert® HPV v2

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Xpert® HPV v2

Reliable Detection of high-risk HPV DNA with Genotyping of HPV 16 and 18/45

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10 Tests

GXHPV2-CE-10

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The Need

Human papillomavirus (HPV) infection is the most common sexually transmitted infection¹
HPV genotypes 16 and 18 are associated with approximately 71% of all cases of cervical cancer, and HPV genotype 45 is associated with approximately 6% of additional cases of cervical cancer.^2,3
HPV NAAT workflows may require batch testing, which can delay result availability.⁴
Rapid HPV results that include integrated high-risk HPV 16 and HPV 18 genotyping support more colposcopy referral decisions.⁵
WHO recommends using a screen-and-treat approach.⁶

1 CDC. Sexually Transmitted Infections (STIs). About Genital HPV Infection. https://www.cdc.gov/sti/about/about-genital-hpv-infection.html#:~:text=HPV%20is%20the%20most%20common,these%20health%20problems%20from%20happening.
2 de Martel C, et al. Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer. 2017;141(4):664–70. doi:10.1002/ijc.30716
3 Chen, A et al. Human Papillomavirus 45 Genetic Variation and Cervical Cancer Risk Worldwide. J Virol. 2014 Apr;88(8):4514-21
4 Kundrod, K et al. Advances in technologies for cervical cancer detection in low-resource settings. Expert Rev Mol Diagn. 2019 Aug;19(8):695-714.
5 Cox JT, et al. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the Athena HPV study. Am J Obstet Gynecol. 2013 Mar;208(3):184.e1-184.e11.
6 WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition. Geneva: World Health Organization; 2021

The Solution

The Xpert HPV v2 test, is an automated, qualitative, in vitro test for the detection of the E6/E7 region of the viral DNA genome from 14 high risk HPV in patient specimens.
Xpert HPV v2 specifically identifies types HPV 16 and HPV 18/45 in two distinct detection channels, and reports 11 other high-risk types in a pooled result
The Xpert HPV v2 test can be used with a Pap specimen or as a first-line primary screening test.

The Impact

Patient Management: Xpert HPV v2 provides partial genotyping, with individual call-outs for high-risk HPV types 16 and 18/45, for primary screening of women who are at risk of developing cervical cancer.⁷
Fast Results: HPV results in around 60 minutes for same-visit clinician/ patient consult, and is aligned with WHO screen‑and‑treat recommendations.⁶
Adaptable: in a decentralized setting in a laboratory environment,including cytology and molecular laboratories.

7 Vassilakos, P et al. A cross-sectional study exploring triage of human papillomavirus (HPV)-positive women by visual assessment, manual and computer-interpreted cytology,and HPV-16/18-45 genotyping in Cameroon. Int J Gynecol Cancer. 2021 Jun;31(6):808-816.
6 WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition. Geneva: World Health Organization; 2021