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Shahky Early Access Program Now Available—Sign-up to Learn More
 

For Healthcare Providers

The industry’s first RNA-based diagnostics are designed to overcome the limitations of currently available molecular diagnostics and deliver on the true promise of personalized healthcare. Our breakthrough molecular diagnostics are designed to guide treatment decisions precisely and in real-time along the entire patient care continuum.

Using a simple blood or urine test, our diagnostics extract critical molecular information from exosomes, microvesicles that contain RNA, DNA, and proteins from their cell of origin and are released by all living cells into biofluids. We refer to our technology as “The True Liquid Biopsy,” as we believe that our exosomal RNA-based platform offers critical advantages over other liquid biopsy platforms, including platforms based solely on cell-free DNA (cfDNA).

Gaining access to molecular information from biofluids without needing direct access to the tissue itself will have far-reaching implications in the treatment of many serious diseases. Our diagnostics are initially focused on cancer, but our exosome-based technology platform is potentially applicable to other diseases or medical conditions where molecular testing is beneficial, but where access to tissue is difficult or impossible. Examples include neurological, endocrine and cardiovascular diseases, among others.

Available Now: ExoDx® Prostate(IntelliScore) ExoDx®Lung(ALK) 

ExoDx Prostate(IntelliScore), now available in the U.S., is a non-invasive, urine-based test designed to be used along with PSA and other standard of care factors (including age, race and family history) to enable physicians to predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer and, thus, could potentially avoid an initial biopsy and, instead, continue to be monitored. Learn more.


ExoDx Lung (ALK), a qPCR-based assay intended for detection of five EML4-ALK fusions in the plasma of patients with NSCLC, is now available to healthcare providers for clinical use. The test is intended as an aid to physicians in the identification of patients with an ALK fusion. The test is intended for those patients who do not have tissue available or are unwilling or unable to undergo repeat biopsy. Learn more.

Liquid Biopsy vs. Tissue Biopsy

Current molecular diagnostics almost exclusively rely on analyzing solid tumor cancer cells from tissue biopsy by needle aspiration or surgical resection. However, tissue biopsy samples may not be available or certain patients are unwilling or unable to undergo repeat biopsy.

Liquid Biopsy Tissue Biopsy
Biofluids are readily accessed and carry a lower risk of complications Invasive surgical tissue procedures may not be practical
Allows for real-time, serial and longitudinal monitoring during cancer therapy Provide a snapshot of disease at a single time point
Provides a more comprehensive view of the tumor’s molecular make-up by collecting biological material from cells throughout the tumor May not provide a complete understanding of the tumor’s molecular makeup, as tumors can be quite heterogeneous
Given the non-invasive nature of liquid biopsies, multiple samples can be collected as needed Yield a limited sample size that can quickly become depleted if tissue needs to be divided and utilized for various diagnostic purposes

Our exoRNA Platform vs. cfDNA-only Liquid Biopsy Platforms

The liquid biopsy space in evolving at a rapid pace. It is critical to understand the differences in liquid biopsy platforms. cfDNA-only platforms, for example, have several limitations that prevent them from providing a truly dynamic and sensitive understanding of a patient’s cancer. We overcome this challenge by using biological information from living cells, which can only be provided by exosomes.

Living cells vs. dying cells

cfDNA is derived from dying cells while RNA comes from living cells. As a result, cfDNA-only liquid biopsy platforms may not provide a complete picture of the molecular make-up of a patient’s tumor. By analyzing cfDNA in conjunction with RNA, our platform can identify new mutations that are arising in living cells as well as the mutations from the cells that are dying. As a result, we are able to provide more comprehensive insight into the molecular evolution of a patient’s disease.

Increased sensitivity

Many mutations are found on two sources of nucleic acid, DNA and RNA. Because of their rarity, analyzing cfDNA alone is likely to face limitations in sensitivity. By combining these molecular materials, our platform has the ability to enhance gene copy numbers and detect low-abundance, rare somatic mutations, which can be missed by analyzing cfDNA only. We have demonstrated the clinical relevance of this approach in several clinical studies:

EGFR activating and T790M resistance mutation in plasma exoRNA and cfDNA, detected with single-step isolation columns and targeted resequencing

Detection of EGFR activating and T790M resistance mutation in plasma of NSCLC patients using combined exosomal RNA and cfDNA capture

Highly sensitive detection of low abundant somatic mutations in circulating exosomal RNA and cfDNA with next-generation sequencing

Versatile and Comprehensive

Both RNA and cfDNA are important sources of biological information. The addition of RNA enables Exosome Diagnostics to also interrogate RNA expression levels, splice variants, fusions, copy number variations and epigenetic changes.

Our True Liquid Biopsy - Key Benefits

Exosomes are small vesicles released by all living cells into biofluids, such as plasma/serum, urine, cerebrospinal fluid and saliva. The majority are between 100 and 200 nm in size. These vesicles have a physiological role as cellular messengers and contain RNA, DNA and proteins. By accessing these vesicles, our technology provides real-time access to comprehensive molecular information about a patient’s disease and response to therapy.

Our proprietary technology platform:

  • Combines RNA, DNA and protein analysis
  • Utilizes fresh or frozen/archived biofluid samples
  • Does not rely on analyzing tissue samples
  • Can complement an initial biopsy or, depending on the patient or application, prevent the need for a biopsy altogether
  • Leverages living cells, enabling a comprehensive and, dynamic view of a tumor’s molecular makeup
  • Enables longitudinal sampling or multiple sampling as needed
  • Leverages routine sample handling to easily fit into clinical lab workflow
  • Identifies disease molecular subtypes
  • Allows monitoring for emerging mutations