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Our Technology

Leaders in Harnessing the Power of Exosomes for Clinical Application

Exosome Diagnostics is the leader in harnessing the power of exosomes and other microvesicles to develop diagnostics that can be used to help better inform the diagnosis, detection, treatment and monitoring of cancer and other serious diseases. In 2016, we launched the industry's first exosome-based diagnostic and are on a path to launch additional tests this year.

We are also pharma’s preferred partner-of-choice in leveraging exosome-based science to enhance the R&D process, from biomarker discovery through validation, and the development of sophisticated companion diagnostics (CDx).

Image courtesy of National Institutes of Health, U.S. Department of Health and Human Services

Exosomes are powerful messengers released by all cells into biofluids (plasma/serum, urine, cerebrospinal fluid and saliva). Exosomes contain RNA, including mRNA, microRNA, lncRNA and other RNA species, as well as DNA and proteins, from their cell of origin. Biofluid exosomes are particularly useful for differential molecular profiling because they are present not only in primary and metastatic cancer but also in inflammatory, metabolic, cardiovascular, neurodegenerative and other disease processes.

With our exosome-based technology, we can achieve real-time access to comprehensive molecular information about cells in the body without direct access to the actual cells. In addition, our technology has the ability to harvest this rich and comprehensive molecular information from any biofluid, fresh or frozen.

Learn more about the advantages of Exosome Diagnostics’ approach versus currently available and other emerging molecular diagnostics approaches and platforms.

Best-in-Class Approach to Exosome-Based Molecular Analysis

At Exosome Diagnostics, we have amassed extensive, unparalleled expertise and intellectual property related to the isolation of exosomes and other microvesicles from biofluids, and the extraction and analysis of their RNA and DNA contents. Through our novel exosome-based approach, we overcome limitations associated with currently available molecular diagnostics and introduce multiple advantages that will deliver the next generation of molecular diagnostics and realize the true promise of personalized patient care.

There are several aspects of our proprietary technology platform that position it as a best-in-class approach for conducting exosome-enabled molecular analysis.

Proprietary Process for Isolating Exosomes from Biofluids

While there are a number of different techniques can be applied to isolate exosomes and other microvesicles from biofluids, our technology platform utilizes a proprietary process that captures and purifies exosomes and achieves high-quality RNA preparations.

Optimized for Clinical Workflow and Scalable, High-Yield Exosome Isolation

We are well-positioned to meet the needs of physicians and patients to receive results quickly in order to guide treatment options while ensuring the highest quality results. From sample collection through results delivery, our approach can be easily integrated into the clinical workflow. The process of collecting biofluids is efficient, practical, routine and cost-efficient for clinicians to manage. Once a sample arrives at our CLIA lab, the process is equally streamlined to enable both the highest quality and maximum efficiency. We utilize spin column-based nucleic acid purification for exosome DNA, RNA and protein extraction. This approach enables us to get comparable quality to an ultracentrifugation process, but in a more efficient and faster manner and utilizing a standard protocol.

In addition, utilizing a spin column enables scalability for high-yield exosome isolation not permitted through other approaches. Since exosomes are shed from many different cells in the body, all contribute to the complex mixture detectable in biofluids. In assays detecting mutations or transcripts that exclusively arise from cancer cells, it is important to isolate as many exosomes as possible to avoid disregarding any unknown or as of yet unidentified subpopulations.

This holistic view is also important if gene signatures or biomarkers are assayed that have contributions from several cell types. In many types of cancer, exosomes arising from the body’s immunologic response to the presence of a tumor may be an important contributor to a biomarker fingerprint in combination with exosomes of tumor origin. In other applications where a subpopulation of exosomes is well characterized and known to contain the relevant targets, it can be beneficial specifically to isolate that subpopulation by affinity capture against surface markers present on these exosomes.

Robust, Versatile Utility and Analysis

Combing the powerful biomarker information that exosomes can reveal and our proprietary technology’s unique ability to extract this information, we can provide powerful diagnostic information throughout the patient care continuum including:

  • Detecting disease earlier to treat patients earlier
  • Identifying disease subtypes to tailor treatment approaches
  • Monitoring disease changes in real-time to adjust treatment approaches

Depending on what a specific diagnostic is designed to reveal about a disease – and which disease and biomarkers we are targeting, we can analyze the high-quality RNA contained within exosomes using a range of downstream molecular biology analytical techniques including polymerase chain reaction (PCR), droplet digital PCR, quantitative PCR (qPCR), microarrays and next-generation sequencing (NGS).

Sample Stability Extends Use of Multi-Year Specimens

One of the important features of exosome composition is the stability of nucleic acid content achieved during long periods of biofluid archiving in biobanks. We have shown that under many conditions, assuming proper storage and procedures, there is little degradation in nucleic acid integrity in fresh versus multi-year biobanked specimens.