Tumor Profiling System for Use in Assignment of Targeted Therapies by Layered Array Analysis
Develop a technique, known as Layered Expression Scanning-Diagnostic, that can better predict whether cancer patients will respond to "personalized" chemotherapy drugs.
Sponsor: 20/20 Gene Systems Inc.9430 Key West Avenue
Rockville, MD 20850
"Personalized" medicine is a strategy for using therapies that are specifically targeted to the molecular characteristics of an individual patient's disease. Diagnostic techniques for determining whether those targeted therapies will be effective on particular patients have entered clinical practice and now appear poised to be a key driver of 21st century medicine. However, many expensive drugs have proved effective in only a narrow subset of treated patients (up to 30 percent). New diagnostics are needed to better predict whether a particular targeted therapy will work for a particular patient. Available techniques for tumor analysis typically fail to meet a critical need, which is to determine the proteins that are expressed in extracted cancerous tissue. 20/20 Gene Systems proposes to overcome this barrier through a novel strategy called Layered Expression Scanning-Diagnostic (LES-Dx). In this technique, biomarkers would be measured on ten or more layers that will be directly applied to the tissue section. Each target protein would then be accurately 'mapped' to one of the applied layers. The 3D stack of layers would then be read using a microscope and a digital imaging technique resembling computed tomography (CT) scans. Thus, the number of biomarkers per test point can be increased without the 'crowding' of signals, simply by adding many physical layers. The proposed technology could improve significantly the response rates of up to six FDA approved targeted cancer therapies, resulting in an estimated $200 million in annual savings to the U.S. healthcare system. This test would measure the expression and activation of proteins in receptors which undergo excessive activity in many cancers. The LES-Dx system will be fully adaptable for all carcinomas. If the project is successful, the benefits to society at large, including the reduction in cancer mortality and the substantial savings in healthcare dollars, are likely to be substantial.