QIAGEN, Exosome Diagnostics to develop biofluid sample prep kits

The companies hope to launch their initial products in the first half of 2014

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GERMANTOWN, Md.—QIAGEN N.V. has begun a partnership withExosome Diagnostics Inc. for the development and commercialization ofhigh-performance sample preparation kits for the processing of nucleic acidsfrom exosomes. No financial terms were released. The partnership bringstogether Exosome Diagnostics' platform technology with QIAGEN consumables andautomation platforms with the potential to enable repeated, real-time genetic"snapshots" of disease from patient samples of blood, urine or cerebrospinalfluid without requiring tissue biopsy. The two companies are aiming for initialproduct launches in the first half of next year.
If the new solutions are successful, QIAGEN's exclusiveagreement with Exosome Diagnostics will include co-development, manufacturingand commercialization of a full product line for the life-science andtranslational medicine markets. The first applications of Exosome Diagnostics'technology are being combined with QIAGEN's microRNA isolation solution, andwill run on QIAGEN automated instrument platforms.
"QIAGEN is a global leader in personalized healthcaresolutions, and Exosome Diagnostics is a leading developer in biofluid-basedmolecular testing. Together we expect to create the 'gold standard' in thisemerging field of exosome-based testing, advancing research and improvinghealthcare," said Dirk Loeffert, vice president of Global Product DevelopmentLife Sciences of QIAGEN. "We believe QIAGEN can bring to market the firstcomprehensive line of products to help researchers and pharmaceutical companiesexplore and monitor disease status using fresh or frozen biofluids, addressingthe critical challenge of access to samples. We also intend to co-developexosome-based workflows for routine use in personalized healthcare, arevolutionary improvement compared to today's widespread dependence on tissuebiopsies, offering the ability to create a new dimension of utility for ourmolecular-testing assay portfolio. This approach holds promise to significantlyimprove medical care as physicians may be able to use real-time molecularinformation to change the care pathway and bring about disease management."
Exosomes are a subpopulation of microvesicles that can beisolated from biofluids such as blood, urine and cerebrospinal fluid.High-quality RNA and DNA can be extracted from exosomes, which are shed bycells under normal and pathological conditions, and purified for analysis.Exosomes also exist as a key part of the body's communication system thatcarries genetic instructions from cell to cell. They contain nucleic acids andproteins from their hosts cells and are generally considered essential forbiomarker discovery when it comes to personalized healthcare diagnostics.Exosome Diagnostics' proprietary technology takes advantage of the presence ofnucleic acids in exosomes to detect and measure the levels of genes associatedwith cancer, neurodegenerative, metabolic, infectious and other diseases.
The exosome technology-driven kits from QIAGEN will enableusers to work with scalable patient sample volumes from as little as 200µ, aswell as RNA capture from frozen, bio-banked fluids. The kits will also enablethe use of plasma, urine and cerebrospinal fluid without requiring specialstabilization or handling, and streamlined clinical laboratory workflow foranalysis on PCR, pyrosequencing and next-generation sequencing instruments.This approach allows such analyses to be performed without requiring tissueand/or cells that might involve invasive procedures.
"Our partnership with QIAGEN brings unprecedented access tokey genetic information directly from a patient's biofluid sample for academic,biomedical research and pharmaceutical drug programs around the world," JamesMcCullough, CEO of Exosome Diagnostics, said in a press release. "We expectthis partnership, focused on development of a broad range of products, willhelp accelerate commercialization of the next generation of minimally invasive,clinical-grade diagnostics for personalized healthcare."
SOURCE: QIAGEN press release

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