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Immunoassay Diagnostics

Compugen initiated its efforts in the field of diagnostic biomarkers in early 2004 with the development of a discovery engine focused on molecules for immunoassay-based diagnostics for various cancers and cardiovascular diseases. By mid-2005, immunoassay-based diagnostics represented the Company's most commercially advanced activity, with multi-product agreements signed with three leading companies in the immunoassay diagnostics field. The immunoassay candidates form the basis of Compugen’s collaborations with Siemens Medical Solutions Diagnostics (formerly Diagnostic Products Corporation), Ortho-Clinical Diagnostics, a Johnson & Johnson company, and Biosite. In these collaborations, our partners select specific markers for further internal development from our existing pipeline and also guide Compugen's discovery efforts so that additional suitable markers may be identified.
Existing Novel Candidate Biomarkers: CGEN-144, CGEN-438, and CGEN-6.

CGEN-144

CGEN-144 is a variant of the Troponin I biomarker for diagnosing acute myocardial infarction. The Troponin I variant is one of a group of putative cancer and cardiovascular biomarkers previously predicted by Compugen’s immunoassay biomarker computational discovery platform. The molecule has subsequently been experimentally verified to be differentially expressed as a serum protein in myocardial infarction patients compared to healthy individuals. In accordance with a recently signed agreement with Compugen, Biosite will develop and select antibodies that bind to CGEN-144 to determine assay sensitivity and specificity in various disease states and as an addition to the current commercial Troponin I test.

CGEN-438

CGEN-438 is a splice variant peptide of the delta-like protein 3 precursor (DLL3). Using a test developed by Compugen to detect CGEN-438 in serum, the blood levels of the peptide were measured in both lung cancer patients and healthy individuals. The CGEN-438 concentrations detected in serum samples of Small Cell Lung Cancer (SCLC) patients were higher than those detected in the controls, demonstrating the potential of CGEN-438 to become a diagnostic biomarker for Small Cell Lung Cancer. CGEN-438 was also found to be expressed, to a large extent, in certain Non-Small Cell Lung cancer serum samples. As such, CGEN-438 may too be used in a biomarker combination test for the diagnosis of Non-Small Cell Lung Cancer.

CGEN-6

CGEN-6 is a splice variant form of the Gastrin Releasing Peptide Precursor (GRP) gene. Similar to CGEN-438, CGEN-6 was detectable at higher protein concentrations in serum samples of Small Cell Lung Cancer (SCLC) patients as compared to control samples. The results also suggest that CGEN-6 may improve CGEN-438 assay performance in a combination test for SCLC.