A prospective clinical study shows that the GeneSearch Breast Lymph Node Assay, a gene-based diagnostic test, has greater sensitivity than traditional intra-operative methods of detecting the spread of breast cancer to the lymph nodes. In the study, sponsored by Veridex LLC, the GeneSearch demonstrated overall sensitivity at least 10 percentage points higher than intra-operative tests.
In the study, which involved 416 evaluable patients across 11 clinical trial sites, sentinel lymph nodes were tested during surgery. In a head-to-head comparison with frozen section, overall sensitivity of GeneSearch was 95.6 percent — 10 points greater than the overall sensitivity of frozen section (85.6 percent). In a comparison with touch preparation, overall sensitivity of GeneSearch was 18 points higher.