Rapid and continuing advances in biomarker testing are not being matched by take-up in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions. One of the paradigmatic examples is BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, development is impeded by data deficiencies, and lack of policy alignment on standards, approval – and the role of real-world evidence in the process - and reimbursement. The acute nature of the problem is compellingly illustrated by the particular challenges facing the development and use of tumour agnostic therapies, where the gaps in preparedness for taking advantage of this innovative approach to cancer therapy are sharply exposed. Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving healthcare and winning advantages for Europe's industrial competitiveness and innovation require an appropriate policy framework – starting with an update to outdated recommendations.

1077 Background: In MBC, positive HR constitute a favourable prognostic factor and predict response to an hormonal therapy. Conversely HER-2 overexpression is an adverse prognostic factor associated with a more aggressive tumor. In this retrospective study we analysed overall survival (OS) and disease-free interval (DFI) of three phenotypes: HR-/HER-2- (triple negative); HR+/HER-2- (luminal) and HER-2 overexpression (HER-2+). Methods: We evaluated 511 patients with a MBC treated at Centre Jean Perrin from 1973 to 2006. A comparative lecture of oestrogenic, progestative and HER-2 receptors was performed by IHC. At present, HR and HER-2 status were re-evaluated on 166 initial tumor sample of this data base by two pathologists (study currently ongoing). Median age of patients was 54.8 years. 120 (23.6%) patients were directly metastatic (M1), 391 (76.4%) relapsed distantly (M0). Metastatic patients received a median number of 2 lines of chemotherapy (range, 0–14) and/or a median number of 1 line (range, 0–8) of hormonotherapy. 92 (55.4%) patients had a luminal phenotype, 48 patients (28.9%) were HER-2+ and 26 patients (15.7%) were triple negative. Results: Among these 166 tumors, OS was significantly different between these three populations (p=0.00056). DFI variation was not signicant (p=0.083). These data showed that: - Luminal phenotype had the better OS (median survival of 36.5 months) and DFI (51.09 months) - HER-2+ phenotype (33 of 48 patients were treated with trastuzumab from 1999) had an intermediate prognostic on OS (median survival of 31.1 months) and DFI (42.2 months) - Triple negative phenotype had a poor prognostic on OS (median survival of 12.8 months) and the worse DFI (32.64 months) Conclusions: In metastatic breast cancer, luminal phenotype patients had the best OS; HER-2+ phenotype (treated by herceptin) had an intermediate OS, and triple negative phenotype had the worse OS. No significant financial relationships to disclose.