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Contact: John Sterling, 914-740-2196,
GEN Reports on Serum Profiling's Impact on Predictive Medicine

New Rochelle, NY, April 1, 2011-"Intense" just might be the best term to describe the biotech industry's pursuit of novel biomarkers for new drug discovery and development efforts, reports Genetic Engineering & Biotechnology News (GEN). Increasing numbers of academic and commercial scientists are focusing on serum profiling, in particular, as a technology for uncovering promising biomarkers for potential applications in personalized medicine, according to the April 1 issue of GEN.

"Serum profiling is leading to the identification of well-defined biosignatures and patterns of biomarker expression across the entire gamut of biomedical research," says John Sterling, Editor in Chief of GEN. "It's also finding a critical use in patient stratification for clinical trials."

At next week's annual conference of the American Association for Cancer Research, for example, Exiqon will present data from its diagnostic program aimed at early detection of colorectal cancer (CRC). The company applied its miRCURY LNA™ Universal RT microRNA PCR system to detect a miRNA signature in blood plasma indicative of CRC. The signature was derived from comparisons of profiles of several hundred miRNAs in about 200 patients with CRC and a comparably sized control group. By the end of 2011, Exiqon expects to complete a validation study that will include about 5,000 patient samples.

Another example of a serum-based test is Biodesix' VeriStrat. It is used in the clinic to predict response to a second-line biotherapeutic treatment option. The test identifies patients who are likely or unlikely to benefit from treatment with erlotinib, an EGFR-TKI in patients with advanced non-small-cell lung cancer. Supporting data was generated following analysis of the BR.21 pivotal trial for erlotinib.

Other companies covered in the GEN article include Luminex, Serametrix, ProFACT Proteomics, and Alphylase.