Products for Clinical Diagnostics and Personalized Medicine

Molecular diagnostics will play a critically important role in 21^st century medicine as selecting optimum therapies will require specialized tests to determine the molecular profile of the disease.  Recent FDA announcements suggest that genomic and proteomic data submission will soon become a mandate for most new drug applications. This will require pharmaceutical and diagnostics companies to partner in co-developing drugs with companion tests. 20/20’s patented technology provides snapshots of the protein profile from tumors, blood samples, and even hair follicles. This allows drug developers to identify the cohorts of patients most likely to respond and helps physicians prescribe personalized therapies to their patients based on the underlying molecular features of their disease.This paradigm was introduced in 1998 when the FDA approved Genentech’s drug Herceptin to treat advanced breast cancer in patients who overexpress the HER-2 protein.  Before Herceptin can be prescribed the tumor must be tested for HER-2 overexpression by one of two conventional tissue analysis techniques, immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).  Unfortunately neither IHC nor FISH have demonstrated the ability to accurately predict patient response to Herceptin since only 30 to 35 percent of patients selected by these tests respond to the drug (CAP Today, Feb 2002).  Experts believe the poor results from IHC and FISH stems from their inability to analyze the downstream regulators and intracellular mediators that influence HER-2 overexpression. These limitations have created an urgent need for improved proteomic tissue analysis tools with the anticipated approvals of several new drugs for which, as with Herceptin, a companion diagnostic will be required.  These drugs include AstraZeneca’s Iressa, Imclone’s Erbitux and OSI’s Tarceva, each of which is directed to the EGFR pathway. click here to read more

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Analysis using P-FILM of differential expression and activity of p38 in mouse xenographs. The proteins from the tissue sections were transferred to a stack of 10 membranes; one of the membranes was probed with an antibody against total p38, the other with antibody against activated (phosphorylated) p38. Data was analyzed using 20/20’s MARKO Image Analysis Software.The results shown here are from studies on frozen sections of tumors grown as mouse xenographs. The tumors were  4-5 mm in diameter allowing them to be prepared for analysis in the macroarray format.