This enabling technology is important for the rapid and efficient generation of genetically evolved sublines that exhibit desired phenotypes for uncovering genetic pathways associated with disease as well as discovery and product development.
Dr. Nicholas Nicolaides, President and Chief Executive Officer of Morphotek, commented, "This is yet another expansion of our intellectual property and further extends Morphotek's competitive advantage in the field of directed cell-based evolution for systems biology and product development."
"The claims in this patent are very broad and cover the genome-wide manipulation of mammalian cells to generate pools of sibs exhibiting a wide range of traits, such as sublines expressing enhanced levels of a therapeutic biologic for scaleable manufacturing as well as evolution of target cells for developing sublines suitable for drug screening and target discovery," added Dr. Philip M. Sass, Executive Vice President and Chief Operating Officer.
The mismatch repair pathway is a highly conserved process that all living organisms use to repair naturally occurring mutations that occur during DNA replication. Morphotek has developed a broad patent estate that covers regulation of this process in single celled organisms such as bacteria, yeast and mammalian cells as well as in more complex multicellular organisms such as rodents and plants. These patents also cover the use of derived organisms for the generation of a variety of commercially important traits (gene and pathway discovery, antibody maturation, vaccine development and titer optimization). Morphotek has formed successful collaborations that implement its proprietary technology for discovery and product development with Abgenix, Centocor, The Ludwig Institute for Cancer Research, The National Cancer Institute, Novo Nordisk, Protein Design Labs, Tanox, The Wistar Institute, Wyeth and the United States military.
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"Today, we are treating almost any woman as though her cancer is aggressive, which puts patients who don't actually need treatment at risk for side-effects of therapy that is not necessary," explains Ian Rabinowitz, M.D., the primary UNM clinician involved in Exagen's initial study. "For early stage breast cancer there are about 70 to 80 percent of patients who are cancer-free and don't actually require therapy after they receive a lumpectomy. At this point in time, we have no way of identifying which patients fall into that category. So, the advantage of a technology such as Exagen's prognostic tests, once it is further validated, is that we can better identify patients that have a very good prognosis and potentially don't actually require therapy," he said.
The study was conducted using a proprietary "pattern of genomic amplification" FISH (e.g., fluorescent in situ hybridization) test or PGA FISH(TM). Due to the small number of markers in each reagent set, Exagen is uniquely able to implement these tests with PGA FISH technology, making them readily usable by any FISH-testing laboratory. Exagen's discovery technology is based on a mathematical approach that enables the company to examine 25,000 genes with no "preference" for one gene over another to define the best, small combination of genes for a specific testing purpose.
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