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Exosome Diagnostics Announces New Data Demonstrating Superior Ability to Isolate and Extract Highly Pure RNA from Serum and Plasma for Research Applications

Company’s novel spin column method offers standardized, reliable method to isolate exosomal RNA

Easy and fast workflow, other characteristics of technology markedly improve on current methods, enabling suitability for routine laboratory use

CAMBRIDGE, Mass., September 3, 2015 – Exosome Diagnostics, Inc., a developer of revolutionary, biofluid-based molecular diagnostics, today announced the publication of new data demonstrating the ability of its proprietary, exosome-based technology to isolate and extract highly pure RNA from serum and plasma samples for use in research laboratories. The data, published in PLOS ONE, an international, peer-reviewed, open-access online journal, showed that Exosome Diagnostics’ technology platform yielded high-quality exosomal RNA (exoRNA) of equal or higher quantity in a faster timeframe and with more consistent results compared to traditional ultracentrifugation methods, which are labor-intensive and subject to significant variability.

“With the explosive rise in targeted cancer therapy development, exosomes are increasingly utilized as an important source of deriving key molecules for biomarker and companion diagnostics development. Extraction and isolation are the first critical step,” said Johan Skog, Ph.D., Chief Scientific Officer, Exosome Diagnostics. “We are very pleased with these new data as they demonstrate the clear advantages of our novel spin column method versus traditional exosomal RNA extraction methods. Using our technology, researchers can maximize the full potential of this incredibly rich source of nucleic acids to explore and deliver cutting-edge scientific advancements.”

A key source of nucleic acids, including RNA, exosomes are cell messengers found in all living cells and are carried throughout the body via biofluids, such as plasma, urine and cerebrospinal fluid. Using exosomes, researchers can achieve real-time access to comprehensive molecular information about cells in the body without needing direct access to the cells.

The data published in PLOS ONE showed that Exosome Diagnostics’ spin column method provides an easy, fast, reliable and scalable workflow that is suitable for routine laboratory use. The technology demonstrated equal or better yields and purity of exoRNA compared to existing products and protocols, and the ability to scale from small to high sample volumes, a key feature that enables the detection of rare, low-abundance mutations. Additionally, the technology demonstrated the ability to isolate all plasma mRNAs and a specific population of miRNAs from exosomes, while excluding protein-associated circulating cell-free miRNAs. Moreover, the exoRNA contained in vesicles remained fully intact and stable during storage, including multiple freeze-thaw cycles, prior to isolation using the newly developed technology. This signals a distinct advantage over RNA isolated from tissue or circulating tumor cells (CTCs), which require stabilization reagents to prevent degradation. 

The first research kits employing the novel spin column method have been developed as part of a partnership between Exosome Diagnostics and QIAGEN, and are commercialized by QIAGEN. These kits, the exoRNeasy Serum/Plasma Midi and Maxi Kits, as well as the exoEasy Maxi Kit for isolation of intact vesicles, are designed to be used by academic and industry researchers for biomarker discovery, liquid biopsy and clinical diagnostic development, and the advancement of targeted therapies.

“We are excited about these results which demonstrate that our exoRNeasy Maxi Kit, developed in partnership with Exosome Diagnostics, is the most sophisticated method for the extraction of RNA from exosomes,” said Markus Sprenger-Haussels, Ph.D., Senior Director and Head of QIAGEN’s Sample Technologies unit for the Life Sciences. “The data also reaffirms our overall leadership position in the emerging field of liquid biopsies, covering pre-analytical solutions for the extraction of cell-free circulating nucleic acids (cfDNA), circulating tumor cells (CTCs), and RNA from exosomes that help researchers gain valuable molecular insights from raw biological materials.”

In addition to research applications, Exosome Diagnostics is leveraging its novel technology platform to advance multiple liquid biopsy tests for lung cancer, prostate cancer, and other solid tumors. These tests, which represent the industry’s first exosome-based diagnostics, will launch as laboratory developed tests (LDT) in the company’s certified CLIA laboratory in 2015.

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About Exosome Diagnostics

Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. The company’s novel exosome-based technology platform can yield comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are detected, diagnosed, treated and monitored. Visit www.exosomedx.com to learn more.

Media Contact:
Liz Melone
Feinstein Kean Healthcare
617-256-6622
liz.melone@fkhealth.com