Hologic HPV detection system meets testing standards

Hologic’s Cervista HPV HR (high risk) and HPV 16/18 tests have met requirements for pre-market approval.

The former was designed to identify each of the 14 types of HPV that can lead to cervical cancer and has been given the go-ahead for two uses.

Firstly, it can be applied for screening patients who have atypical squamous cells of undetermined significance (ASC-US) and help to distinguish whether they need referral to colposcopy.

The test can also be used as an adjunct to cervical cytology for women over the age of 30 in assessing the presence of high-risk HPV types.

HPV 16/18 has also been approved for two different uses – adjunctively with the Cervista HPR HR test in cases involving ASC-US and as a similar adjunct in patients over 30.

Jack Cumming is chairman and chief executive officer of Hologic. He said the company was "excited" about the decision.

"Our state-of-the-art Cervista HPV tests individually and in combination are designed to provide significant advantages over the existing technology and should help solidify our leadership in cervical cancer screening," he added.

It recently emerged that a lower age limit could be put into place for women to begin cervical cancer screening in the UK.

This type of procedure currently begins in the UK when a female reaches the age of 25.