Qiagen and Exosome Diagnostics to Create Exosome-Based Testing

Standardized, easy-to-use exosome workflows will offer superior testing solutions from basic research to personalized healthcare on widely available PCR, pyrosequencing, and next-generation sequencing technologies. Molecular testing of biofluids promises access to gene mutations, gene expression signatures, and expression levels without costly, invasive tissue biopsies.

Qiagen (Hilden, Germany) has formed a partnership with Exosome Diagnostics Inc. (Germantown, MD, USA) 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 scientists, drug developers, and doctors to take repeated, real-time genetic "snapshots" of disease without the need for tissue biopsy. The companies are targeting initial product launches in the first half of 2014. Financial terms were not disclosed.

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.

Exosomes are one of many different subpopulations of microvesicles that can be isolated from biofluids. RNA and DNA that can be extracted from these exosomes are high quality 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 personalized healthcare diagnostics. Tumor cells release exosomes, which contain tumor-specific RNAs that can be isolated easier from biofluids 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’s exosome technology-driven kits will offer distinct advantages including the ability to work with scalable patient sample volumes, from as little as 200 µL; RNA capture from frozen, biobanked fluids; the use of plasma, urine, and cerebrospinal fluid with no special stabilization or handling required; and clinical laboratory workflow for analysis on appropriate instruments. Previously, such analysis would have potentially required invasive procedures for patients.

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. This is of particular interest for analysis of RNA-based biomarkers such as ALK or RET.

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