Cancer Genetics, Inc. (CGI) announces that it has been chosen by Gilead Sciences Inc. (Gilead) to provide clinical trial services and molecular profiling of chronic lymphocytic leukemia (CLL) patients. The trials cover both national and international locations. CGI will leverage its SelectOne™ program that includes proprietary genomic assays in CLL, data and logistics management, and comprehensive CLIA- and CAP-accredited clinical laboratory testing. The ongoing studies consist of testing across several methodologies, including flow cytometry, FISH, and molecular diagnostics assays including mutational analyses of IGHV, TP53, NOTCH1, and CGI’s proprietary array-CGH assay for mature B-cell neoplasm, MatBA®-CLL/SLL.
Targeted therapies have the potential of improving the lives of cancer patients and providing them with better treatment outcome. CGI’s SelectOne™ offering empowers biotech and pharma companies like Gilead to achieve their goals in oncology clinical trials through the use of CGI’s comprehensive oncology focused menu and proprietary microarrays.
CGI expects the trials to continue for the next several years, and may potentially enable an expedited and more efficient development timeline based on improved patient stratification. CGI also offers comprehensive CLL testing to cancer centers, oncologists and community hospitals under its CLL CompleteSM offering. This includes the assessment of ZAP-70, CD38, mutational status of IGHV, TP53 and SF3B1, genomic alterations by FISH and by a proprietary genomic microarray – MatBA®-CLL/SLL which includes a comprehensive report stratifying the risk and potential outcome, to guide disease and patient management. CLL is a clinically heterogeneous disease and the most common form of leukemia in the Western Hemisphere. It is estimated that in the United States there is a new case diagnosed every forty minutes and there are over 110,000 people living with CLL.