The HERmark® Breast Cancer Assay meets the US standards for performance characteristics and all other quality control and assurance requirements established by the Clinical Laboratory Improvement Amendments (CLIA). HERmark® Breast Cancer Assay is a proprietary, protein-protein assay based on an electrophoresis technology platform. HERmark® and VeraTag™ are trademarks of Monogram Biosciences, Inc. This test was developed and its performance characteristics determined by Monogram Biosciences. It has not been cleared or approved by the US Food and Drug Administration