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Cervista HPV tests

High-risk human papillomavirus (HPV) testing can be extremely valuable in determining an individual’s risk for developing cervical cancer – but only if clinicians and laboratories can feel confident in the test results. Hologic addresses the need for superior accuracy and reliability with the Cervista HPV HR and Cervista HPV 16/18 tests. The first FDA-approved test to detect all 14 oncogenic strains of HPV, Cervista HPV HR minimizes both false positive and false negative test results that can stem from low-risk cross-reactivity and lack of cellular material. The Cervista HPV 16/18 test enables you to individually identify and differentiate high-risk types 16 and 18, which are associated with over 70% of all cervical cancers. So you can further stratify patients at highest risk for developing the disease, which can ultimately guide subsequent treatment decisions for enhanced patient care.


Hologic has been pioneering advances in cervical cancer screening since the approval of the ThinPrep Pap test in 1996. In 2009, Hologic introduced the Cervista HPV HR test, the first FDA-approved HPV test with an internal control to confirm specimen adequacy. The Cervista HPV HR test is an in vitro diagnostic test that detects 14 high-risk types of human papillomavirus (HPV). It reduces false negative results due to insufficient cellularity, providing results you can deliver with confidence.

The Cervista HPV HR test is used to screen patients with atypical squamous cells of undetermined significance (ASC-US), yielding the cervical cytology results required to determine if a referral to colposcopy is needed. In women 30 years of age and older, the Cervista HPV HR test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types.

Hologic also introduced the first FDA-approved genotyping test: the Cervista HPV 16/18 test, which identifies the two most highly oncogenic and persistent high-risk HPV types known to cause 70% of all cervical cancers. The Cervista HPV 16/18 test provides important clinical information for individual risk assessment, enabling you to identify patients at greatest risk for developing the disease.

  • Targets E6/E7 regions – Oncogenes that are required for disease progression.1,2
  • Redundancy – Targets multiple regions on the HPV virus to protect against missing disease due to polymorphisms.1,3
  • Internal control.3
  • No cross-reactivity with common low-risk types3 – Minimizes false positive results and the potential for over-treating patients.

In addition, Cervista HPV 16/18 individually identifies and differentiates high-risk types 16 and 18,4 providing clear clinical utility in line with established patient management algorithm (ASC 2012, ASCCP 2009).5,6


1 Bartholomew, et al. J Clin Virol. 2011;51(1):38-43.
2 Lambert PF, et al. Proc Natl Acad Sci U S A. 1993;90(12):5583-7.
3 Cervista HPV HR package insert #15-3053 2011.
4 Cervista HPV 16/18 package insert #15-2101 2010.
5 Clinical Update, Algorithm for HPV Genotyping, American Society for Colposcopy and Cervical Pathology, 2009.
6 Saslow D, et al. AJCP. 2012;137:516-542.