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Hologic Announces the APTIMA HPV Assay Now Approved for Cervical Screening in the Netherlands

APTIMA HPV assay accurately detects the HPV types most likely to progress to cervical cancer

Hologic, Inc.'s APTIMA HPV Assay, used for detecting human papillomavirus (HPV), has been approved by the NVVP (Dutch Society for Pathology) for use in the Dutch national cervical screening programme (BVO).i

HPV is one of the most common sexually transmitted infections (STIs) and is recognized as the leading cause for most cervical cancers. The National Institute for Public Health and the Environment in the Netherlands (RIVM) suggests routine Pap testing and triage for atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion (ASCUS/LSIL) testing for women over the age of 30 as a means to identify women most likely to develop cervical cancer.ii

The APTIMA HPV assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of HPV in cervical specimens. 

"By detecting mRNA of the oncogenes E6/E7, the specific genes necessary for cervical disease progression, the APTIMA HPV test is an excellent diagnostic tool to help healthcare providers assess a patient's risk of developing cervical cancer while minimizing the risk of false positive results that can cause unnecessary clinical management and create patient anxiety," said Wayne Taylor, Vice President and General Manager Europe, Diagnostics. 

In addition to the APTIMA HPV assay, Hologic also offers the Cervista DNA-based HPV test. Hologic is the only molecular diagnostics assay supplier with a broad offering that includes four FDA-approved and CE-Marked HPV assays. Both tests offer improved specificity over other testing methods because Hologic assays are designed not to cross-react with the most common low-risk HPV types. Hologic assays can be run on a variety of platforms to match throughput capabilities of a wide range of labs: manual or MTA (medium throughput automation) for the Cervista HPV assay, and the PANTHER or TIGRIS systems for the APTIMA HPV assay. 

The APTIMA HPV Assay approval comes just seven months after the NVVP approved the Cervista HPV HR test, meaning Dutch laboratories now have access to both mRNA- and DNA-based HPV assays from Hologic.