Introducing Cervista HPV

Cervista HPV HR

Genotyping for High-risk HPV Types 16 & 18

Cervista® HPV 16/18 is the first HPV genotyping test approved by the FDA, allowing you to individually identify and differentiate high-risk types 16 and 18. Generally considered the two most highly oncogenic and persistent high-risk HPV types, 16 and 18 are associated with approximately 70% of cervical cancers. A prominent long-term study1 reported that types 16 and 18 are respectively 5.5 and 4.5 times more likely to cause CIN 3+ than all other high-risk HPV types combined.

The Cervista HPV 16/18 test provides important clinical information for tailored patient management. Like the Cervista HPV HR test, Cervista HPV 16/18 is built on Invader® chemistry allowing for accurate detection of these two high-risk strains. Best of all, both tests, Cervista HPV HR and Cervista HPV 16/18, can be run from the same 2 mL sample taken from the ThinPrep® Pap Test.

Why Cervista HPV 16/18?

The increased risk associated with HPV types 16 and 18 is well documented. Many studies have also reported that women infected with HPV types 16 and 18 specifically, have a significantly higher risk for developing CIN3+ in comparison with women infected with all other high-risk types. Khan et al1 reported that 21% of cytology-negative, HPV 16-positive women developed CIN3+ over a 10-year period, while 18% who were cytology-negative and HPV 18-positive developed CIN3+ during this period; for all other high-risk HPV types combined, only 1.5% developed CIN3+, underscoring the value in genotyping specifically for HPV 16 & 18 in evaluating a patient’s risk for developing cervical cancer.


Risk Stratification using HPV Types 16 and 18: Portland Study Findings. 1,2

Who Should Be Tested?

While the role of genotyping continues to evolve, guidelines have been issued to address cytology negative, HPV positive women 30 years of age and older. This algorithm, issued by the American Society for Colposcopy and Cervical Pathology (ASCCP) states that "…in cytology negative women 30 years and older who are HPV DNA positive (for any of the 13 or 14 high-risk types of HPV detected by the high-risk HPV assays) molecular genotyping assays that detect HPV 16 and 18 would be clinically useful for determining which women should be referred for immediate colposcopy, and which could be followed-up with repeat cytology and high-risk HPV testing in 12 months2."

Indications for use

The Cervista HPV 16/18 test is indicated:

  • 1. In women 30 years and older the Cervista HPV 16/18 test can be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
  • 2. To be used adjunctively with the Cervista HPV HR test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.

Warnings:

  • This test is not intended for use in determining the need for treatment (i.e.excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV 16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines.
  • The Cervista HPV 16/18 test is not intended for use as a stand-alone assay. Results should be interpreted in conjunction with the Cervista HPV HR and cervical cytology test results.
  • The Cervista HPV 16/18 test is not intended for use in women under age 30 with normal cervical cytology.
  • The Cervista HPV 16/18 test is not intended to substitute for regular cervical cytology screening.
  • The use of this test has not been evaluated for the management of women with prior cytological or histological abnormalities, hysterectomy, who are pregnant, postmenopausal, or who have other risk factors (e.g. HIV+, immunocompromised, history of STI).

The Cervista HPV 16/18 test is designed to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.

Cervista HPV 16/18 test results should not be used as the sole basis for clinical assessment and treatment of patients.

Consult package insert for full clinical details: Cervista®

Learn more about the advanced clinical performance and improved workflow offered by Cervista HPV HR in the laboratory.

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