“In the era of precision medicine, the role of biomarkers in guiding clinical care is greater than in the past. An extensive number of new tests have come out in the last 5 to 10 years, but not all have sufficient evidence of clinical utility,” Lyndsay N. Harris, professor of medicine and co-chair of the ASCO expert panel that developed the guideline, stated in a press release.
The guidelines recommending proper use of biomarker assays are based on an extensive literature review of studies published between 2006 and 2014. These encompass systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and observational studies. Harris and colleagues also included studies reporting data on overall survival, relapse-free survival, and disease-free survival. They identified 50 breast cancer studies, of which 19 evaluated the feasibility of using biomarker assays for determining adjuvant (post-operative) systemic therapy.
Based on this data, the ASCO panel recommend the use of Oncotype DX (Genomic Health), EndoPredict (Sividon Diagnostics), PAM50 (Prosigna, NanoString Technologies), Breast Cancer Index (Bio Theranosti