Establishment of the Australian In Situ Hybridisation Program for the Assessment of HER2 Amplification in Breast Cancer: A Model for the Introduction of New Biomarkers into Clinical Practice
G Farshid, JE Armes, R Bell, M Cummings, S Fox, G Francis, M Haswell, A Morey, G McCue, W Raymond, P Robbins, M Bilous. SA Pathology, Adelaide, SA, Australia; Mater Health Services, Brisbane, QLD, Australia; Andrew Love Cancer Centre, Geelong, VIC, Australia; Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; Peter MacCallum Cancer Institute, Melbourne, VA, Australia; Princess Alexandra Hospital, Brisbane, QLD, Australia; Roche Australia, Sydney, NSW, Australia; St Vincent's Hospital, Sydney, NSW, Australia; Woolomin Consulting, Crookwell, NSW, Australia; Flinders Medical Centre, Adelaide, SA, Australia; Queen Elizabeth II Medical Centre, Perth, WA, Australia; Westmead Hospital, Sydney, NSW, Australia
Background: In August 2006 the Australian government announced a decision to subsidise trastuzumab therapy for early breast cancer, to commence six weeks later. It was mandated that HER2 gene amplification, determined by in situ hybridisation (ISH), be demonstrated, and that the sponsor company, Roche Products Pty Ltd, should fund this testing. This announcement potentially required provision of ISH testing for HER2 for every newly diagnosed breast cancer, where previously HER2 testing had been based on immunohistochemistry with support from a single fluorescent ISH (FISH) reference laboratory for indeterminate cases.
Design: The Australian HER2 Testing Advisory Board, an independent expert group, responded to the challenge of rapidly providing accurate nationwide ISH testing. Bright field ISH was selected as the testing platform and a decentralised testing model, with support from a central FISH laboratory, was adopted. An implementation plan was developed addressing standards for training, accreditation and quality assurance.
Results: Within six weeks eight pathology laboratories were accredited for ISH testing and by September 2008, two years after the announcement, 22 ISH testing laboratories were taking part in the national program and almost 20,000 ISH tests had been performed.
Conclusions: This abstract describes the design and rapid implementation of a nationwide program of bright field ISH as the first-line testing platform for HER2 status in early breast cancer. We believe this model for the coordinated and large scale implementation of a new biomarker test has wider application, given that accurate assessment of a range of novel biomarkers is being used increasingly to determine eligibility for new targeted treatment modalities.
Tuesday, March 23, 2010 1:00 PM
Poster Session IV # 15, Tuesday Afternoon