Molecular Pathology Laboratory Network

The U.S. Food and Drug Administration (FDA) approved Hologic, Inc.’s premarket approval application for the Cervista HPV 16/18 tests, which is performed at MPLN. Cervista HPV 16/18 is the first HPV test cleared for genotyping for HPV types 16 and 18.

High-risk HPV types 16 and 18 represent the most oncogenic and persistent types of the human papillomavirus and are known to cause approximately 70% of cervical cancer in the United States. Previous studies have shown HPV 16 and 18 are respectively 5.5 times and 4.5 times more likely to cause cancer than all other high-risk HPV types combined.

The Cervista HPV 16/18 genotyping test was cleared to be used adjunctively in women 30 years and older with a high-risk HPV test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types.

The test was also cleared as an adjunct with a high-risk HPV test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to assess the presence or absence of specific high-risk HPV types.

For more information about high-risk HPV testing and HPV genotyping, contact a client service specialist at MPLN at 800.932.2943.