Agreements

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. 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’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.

* On January 13, 2014, Qiagen has announced an expansion of its strategic partnership with Exosome Diagnostics Inc. to develop a first-in-class, non-invasive molecular in vitro diagnostics for use in diagnosing and monitoring patients. The novel blood based diagnostic detects certain mutations of an undisclosed gene associated with non-small cell lung cancer (NSCLC) and other malignancies and has the potential to be paired with several new anticancer therapeutics. Qiagen will have worldwide exclusive rights for commercialization and intends to submit the test to the FDA following clinical validation. Financial terms were not disclosed. In 2013, QIAGEN and Exosome Diagnostics announced plans to launch the first in a series of high-performance sample preparation kits for processing nucleic acids from biofluid exosomes during the second quarter of 2014.