Authors' objectives: The HPV OncoTect™ E6, E7 mRNA assay is a new test for the early detection of cervical cancer. The primary aim of the test is to guide the referral of women with an unsatisfactory or abnormal screening cytology result for additional, more invasive, testing (colposcopy or biopsy, or both). If the HPV OncoTect™ E6, E7 mRNA assay has better diagnostic accuracy than current testing methods, it may reduce the number of women who are needlessly referred for invasive testing.

Authors' recommendations: Based on the current level of evidence on its diagnostic accuracy, the HPV OncoTect™ E6, E7 mRNA assay may prove to have better clinical utility for the triage of abnormal cytology results for colposcopy than HPV DNA testing and repeat LBC. The HPV OncoTect™ E6, E7 mRNA assay is one specific test in a range of tests which may be considered for inclusion in Australia's cervical cancer screening program. This report can contribute to the ongoing debate around HPV triage testing in Australia, but the decision to include an additional test in the NCSP is beyond the responsibility of HealthPACT. It is recommended that this brief be sent to the NCSP and MSAC for consideration, and that further assessment of the technology by HealthPACT is no longer warranted.

Project Status: Completed

Year Published: 2014

URL for published report: https://www.health.qld.gov.au/healthpact/docs/briefs/WP174.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical

Contact Address: ASERNIP-S 24 King William Street, Kent Town SA 5067 Australia Tel: +61 8 8219 0900

Contact Name: racs.asernip@surgeons.org

Contact Email: racs.asernip@surgeons.org

Copyright: Australian Safety and Efficacy Register of New Interventional Procedures -Surgical (ASERNIP-S)