LAUSR

12Background: With the growing number of therapies that are directed against specific biomarkers, or discrete subsets of cancers, it is increasingly important to prospectively identify the most appropriate subjects for enrollment in a randomized, controlled clinical trial. Historically, clinical trial enrollment was strictly guided phenotypically. Subjects were included in a study simply based on presentation and disease progression, regardless of any underlying molecular mechanisms. Methods: Aegis involves the use of multiple molecular genetic procedures to investigate clinical trial subjects, whether for enrollment or disease monitoring. Fluorescent in situ hybridization (FISH) to detect chromosomal aberrations and single-gene Sanger sequencing are utilized to identify subjects with abnormalities associated with cancers such as chronic lymphocytic leukemia (CLL) prior to enrollment. Gene expression analysis using Nanostring digital RNA counting to stratify diffuse large B-cell lymphoma subjects, B-cell ...