Qiagen and Exosome Diagnostics partner to create biofluid sample preparation kits

Qiagen and Exosome Diagnostics have announced a partnership to develop and commercialise high-performance kits for the capture and processing of RNA and DNA from biofluid exosomes and other microvesicles. Combining Exosome Diagnostics’ platform technology products with select Qiagen consumables and automation platforms, it is hoped that the partnership will allow researchers, drug developers and doctors to obtain repeated, real-time genetic snapshots of disease from patients’ blood, urine or cerebrospinal fluid without the need for tissue biopsy.

Exosomes and other extracellular vesicles can be isolated from biofluids, from which high-quality nucleic acids such as mRNA, miRNA and DNA can be extracted and purified for analysis. 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 cell, and are widely considered to be essential for biomarker discovery for personalised medicine diagnostics. Furthermore, the natural stability of the exosome compartment allows collection of clinical samples without special tubes or preservatives, so researchers can perform analysis and biomarker discovery on high-quality RNA from both fresh and frozen biofluid samples.

Exosome Diagnostics CEO James McCullough said the partnership “brings unprecedented access to key genetic information directly from a patient’s biofluid sample”. He expects the partnership, “focused on development of a broad range of products, will help accelerate commercialisation of the next generation of minimally invasive, clinical-grade diagnostics for personalised healthcare”.

Subject to successful performances of the new solutions, the exclusive agreement will cover co-development, manufacturing and commercialisation 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 commercialisation of clinical in vitro diagnostic products for a range of non-invasive personalised healthcare solutions.

“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,” said Dirk Loeffert, Vice President Global Product Development Life Sciences of Qiagen.

“We also intend to co-develop exosome-based workflows for routine use in personalised 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.”

The exosome technology-driven kits will offer the following advantages:

• The ability to work with scalable patient sample volumes, from as little as 200 µL
• RNA capture from frozen, bio-banked fluids
• The use of plasma, urine and cerebrospinal fluid with no special stabilisation or handling required
• Streamlined clinical laboratory workflow for analysis on PCR, pyrosequencing and next-generation sequencing (NGS) instruments

The companies are targeting initial product launches in the first half of 2014.