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Cervista HPV HR assay

At Hologic, we work tirelessly to improve early detection of cervical disease. One such Hologic solution that supports this objective is the Cervista HPV HR test, which provides accurate and reliable results.  The Cervista HPV HR test was the first FDA-approved test to detect all 14 oncogenic strains of HPV.

About

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).

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.

Performance Data

In a US-based multi-center prospective clinical study, the Cervista HPV HR assay demonstrated 100% clinical sensitivity and 100% negative predictive value (NPV) for CIN3+ among 1,347 women with ASC-US cytology.1

Regulatory

The Cervista HPV HR assay was FDA-approved for in vitro diagnostic use in the U.S. in March 2009. The Cervista HPV HR assay was CE-marked in December 2007.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

References
  1. Cervista HPV HR package insert #15-3100 revision 102, 2012.