Development of a Clinical Gastroesophageal Carcinoma Multiplexed SRM Assay and Assessment of Assay Performance in Patient Tissues

摘要

We have developed a clinical assay for diagnosing Her2 overexpression in FFPE gastroesophageal tumors using Liquid Tissue-SRM. This assay is currently available as a clinical lab developed test (LDT) run in our CLIA-certified facility. Liquid Tissue-SRM provides a robust and reproducible technology to measure up to 20 target proteins in a single FFPE tissue; an important consideration since clinical tissue is often allocated for multiple diagnostic tests (e.g., standard pathology, IHC, genetic sequencing, FISH, etc.). Unlike IHC, Liquid Tissue-SRM provides high specificity, sensitivity, and can be easily standardized across multiple laboratories enabling highly accurate, and objective quantitation of clinically important protein biomarkers.