The UK’s National Institute for Health and Care Excellence (NICE) has expanded its recommendation for three prognostic gene expression tests to aid in determining adjuvant chemotherapy for a broader group of early breast cancer patients. Myriad Genetics’ EndoPredict(Myriad Genetics recently announced European operations restructuring, selling EndoPredict business to Eurobio Scientific.), Veracyte’s Prosigna, and Exact Sciences’ Oncotype DX are now endorsed for postmenopausal women or men with estrogen receptor-positive, HER2-negative early breast cancer and one to three positive lymph nodes, extending beyond the previous recommendation limited to lymph node-negative patients.
This final guidance, applicable to NHS patients in England and Wales, signifies a significant shift in treatment protocol. However, MammaPrint, Agendia’s breast cancer risk assessment test, did not receive NICE’s endorsement due to concerns regarding its clinical effectiveness and higher costs compared to standard care.
NICE’s independent diagnostic advisory committee made these recommendations based on robust evidence supporting the efficacy of the three endorsed tumor profiling tests. Notably, the companies have agreed to offer these tests to the NHS at a discounted price, ensuring cost-effectiveness.
Mark Chapman, interim director of NICE’s Health Technologies Program, emphasized the committee’s dedication to providing NHS patients with innovative, evidence-based care while prioritizing value for taxpayers’ money. This decision underscores NICE’s commitment to enhancing patient outcomes through the integration of advanced diagnostic technologies into clinical practice.