Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Australian Safety and Efficacy Register of New Interventional Procedures -Surgical (ASERNIP-S). HPV OncoTect™ E6, E7 mRNA assay to guide colposcopy referral in cervical cancer screening
. Australia: Australian Safety and Efficacy Register of New Interventional Procedures -Surgical (ASERNIP-S). Technology Brief. 2014 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' conclusions 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. Indexing Status Subject indexing assigned by CRD MeSH Cervical Intraepithelial Neoplasia; Colposcopy; Early Detection of Cancer; Female; Gene Expression Regulation, Virals; Oncogene Proteins, Viral; Papillomaviridae; RNA, Messenger Papillomavirus DNA Tests Language Published English Country of organisation Australia English summary An English language summary is available. Address for correspondence 199 Ward Street, North Adelaide SA 5006, Australia. Tel: +61 8 8219 0900, Fax: +61 8 8219 0999 Email: asernips@surgeons.org AccessionNumber 32015000984 Date abstract record published 08/09/2015 |