Qiagen, a leading global provider of sample & assay technologies, has collaborated with Exosome Diagnostics Inc., a developer of biofluid-based molecular diagnostic tests, to develop and commercialize high-performance sample preparation kits for the processing of nucleic acids from exosomes. Combining the Exosome Diagnostics platform technology approach with select Qiagen consumables and automation platforms has the potential to allow researchers, drug developers and doctors to take repeated, real-time genetic "snapshots" of disease from patients' blood, urine or cerebrospinal fluid without the need for tissue biopsy.

The companies are targeting initial product launches in the first half of 2014. Financial terms were not disclosed.

Subject to successful performances of these new solutions, Qiagen 's exclusive agreement with Exosome Diagnostics will cover co-development, manufacturing and commercialization of a full product line for the life science and translational medicine markets. First applications of Exosome Diagnostics' technology are being developed with Qiagen 's microRNA isolation solutions and are designed to run on Qiagen automated instrument platforms. The product portfolio is also expected to create the basis for development and commercialization of clinical in-vitro diagnostic products for a range of non-invasive personalized healthcare solutions.

Exosomes are one of many different subpopulations of microvesicles that can be isolated from biofluids such as blood, urine and cerebrospinal fluid and from which high-quality RNA and DNA can be extracted and purified for analysis. Exosomes are shed by cells under both normal and pathological conditions. They are a key part of the body's complex communication system that transfers genetic instructions from cell to cell through all biofluids. Exosomes carry nucleic acids and proteins from their host cells and are widely considered to be essential for biomarker discovery for personalized healthcare diagnostics. Tumor cells, for instance, release exosomes which contain tumor-specific RNAs that can be isolated easier from biofluids such as blood and urine than from biopsies. Exosome Diagnostics' proprietary technology makes use of the presence and stability of nucleic acids in exosomes to detect and measure levels of genes implicated in cancer, neurodegenerative, metabolic, infectious and other diseases.

"Qiagen is a global leader in personalized healthcare solutions, and Exosome Diagnostics is a leading developer in biofluid-based molecular testing. Together we expect to create the ‘gold standard' in this emerging field of exosome-based testing, advancing research and improving healthcare," said Dirk Loeffert, vice president, Global Product Development Life Sciences of Qiagen . "We believe Qiagen can bring to market the first comprehensive line of products to help researchers and pharmaceutical companies explore and monitor disease status using fresh or frozen biofluids, addressing the critical challenge of access to samples. We also intend to co-develop exosome-based workflows for routine use in personalized healthcare, a revolutionary improvement compared to today's widespread dependence on tissue biopsies, offering the ability to create a new dimension of utility for our molecular testing assay portfolio. This approach holds promise to significantly improve medical care as physicians may be able to use real-time molecular information to change the care pathway and bring about disease management."

James McCullough, chief executive officer of Exosome Diagnostics, said, "Our partnership with Qiagen brings unprecedented access to key genetic information directly from a patient's biofluid sample for academic, biomedical research and pharmaceutical drug programs around the world. We expect this partnership, focused on development of a broad range of products, will help accelerate commercialization of the next generation of minimally invasive, clinical-grade diagnostics for personalized healthcare."

Qiagen 's exosome technology-driven kits will offer distinct advantages including the ability to work with scalable patient sample volumes, from as little as 200µL; RNA capture from frozen, bio-banked fluids; the use of plasma, urine and cerebrospinal fluid with no special stabilization or handling required; and streamlined clinical laboratory workflow for analysis on PCR, pyrosequencing and next-generation sequencing (NGS) instruments. Previously, such analysis would have depended on the use of tissue and/or cells, potentially requiring invasive procedures for patients.

As part of an active biological packaging and distribution mechanism for RNA and DNA, exosomes and their nucleic acid contents are being investigated for their implications and utility in a broad range of diseases including cancer, central nervous system disorders such as Alzheimer's and Parkinson's diseases, cardiovascular disease, maternal/fetal medicine, and chronic kidney disease. The natural stability of the exosome compartment allows collection of clinical samples without special tubes or preservatives. As a result, researchers can perform analysis and biomarker discovery on high-quality RNA from both fresh and frozen plasma, serum, urine and cerebrospinal fluid samples. This is of particular interest for analysis of RNA-based biomarkers such as ALK or RET.

Qiagen , is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information.

Exosome Diagnostics is a leading developer of biofluid-based molecular diagnostic tests for use in personalized medicine.