Leading the Fight

Leading the Fight: Developing Cutting Edge Diagnostics

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GOAL

The projects described below are proposed for the development of novel methods to diagnose and monitor selected diseases, including certain cancers, immune-mediated disorders, and other conditions.

PURPOSE

The majority of these diseases and conditions have no currently available reliable diagnostic tests. These tests will be developed as blood tests so they become important non-invasive tests.

Project Components:

Fast Track the Diagnosis: Improving Molecular Diagnostics for Canine Lymphoma - Early Success Achieved
As a reflection of the successful and efficient Ethos Discovery scientific strategy, less than 1 year ago Ethos Discovery embarked upon a research strategy to develop a needed improvement to an existing molecular assay used in the diagnosis of canine lymphoma.

This existing assay, referred to as the PCR for Antigen Receptor Rearrangement (PARR) is able to distinguish normal lymphocytes from malignant lymphocytes based on cancer-specific rearrangements in the genes of the adaptive immune response. This test is offered by multiple commercial and academic laboratories.

Through the optics of unmet needs in our clinics, we defined a strategy to deliver improvements in this assay. These include additional flexibility in the types of samples that could be used for the assay, refinements to allow smaller samples to be used, and improvements in the accuracy of the assay.

Through a collaborative effort with the Translational Genomic Research Institute (TGen), the Ethos Discovery team has developed an assay, “ePARR,” that has these differentiated attributes. Publication of data summarizing these advantages is planned for early 2018. We predict its use in pet animal patients through a commercial release in 2019.

In parallel we have begun work through the National Institute of Health granting mechanisms to utilize the ePARR platform to develop needed tests for human patients.
Fast Track the Diagnosis: Canine Lymphoma, Extending Early Successes
A great unmet need exists in canine oncology for the discovery and clinical detection of genomic prognostic biomarkers in lymphoma in a low-cost assay format that entails significant flexibility in sample requirements.

The ePARR test (listed as project component above) provides a compelling framework from which to build such a test.

Ethos Discovery now stands poised to launch the research studies that will develop and validate a game-changing assay for canine lymphoma that will allow clinicians to determine the prognosis prior to treatment. We are hopeful that this successful approach to changing the biology of complex medical problems will deliver a new diagnostic test that can be shared with both human and veterinary patients.
Fast Track the Diagnosis: Lymphoma in Cats
Lymphoma is a common cancer seen in dogs and cats. In some cases the diagnosis of lymphoma can be complicated. While there are molecular tests available to make this diagnosis definitive in dogs, these tests have significant shortcomings in cats.

In this project we will employ next-generation sequencing strategies to improve these molecular tests for cats.

Project Components:

When Immune Systems Go Rogue: Unraveling the Mysteries of Exosomal DNA
Immune-mediated diseases are conditions where the immune system loses appropriate regulation, resulting in the immune system attacking normal cells rather than diseased cells.

In dogs, common immune-mediated diseases of the blood have no current reliable diagnostic test. Diseases in this class include immune-mediated thrombocytopenia (platelet destruction) resulting in a life-threatening inability to effectively control bleeding in the dog, and immune medicated hemolytic anemia (red blood cell destruction), resulting in life threatening anemia.

In both of these conditions, the absence of an effective diagnostic test results in delays in diagnosis and initiation of therapy. We seek to create genomic-based tests for these complicated disorders of the immune system.

This study will develop needed blood tests for complex immune-mediated diseases in dogs. A valuable new source of DNA material has been identified in simple blood samples. This DNA material (exosomal DNA) is believed to come from normal blood cells in response to a disease state.

We have successfully identified exosomal DNA from the blood of dogs, and now stand poised to collaborate with an international leader in this technology. Through this collaboration we will compare exosomal DNA fingerprints from dogs with specific disease states to exosomal DNA in healthy dogs. By doing so, we hope to develop a number of diagnostic blood tests for important medical conditions in dogs.
Fast Track the Diagnosis: Toxin Exposure Screening
Toxin exposure is a common, life-threatening presentation for pets to emergency practices. The clinical signs associated with toxin exposure are often diverse, and frequently resemble other medical problems. The diagnosis of a toxicity commonly must be presumed based on a history of potential toxin exposure and the elimination of other medical problems that may be associated with similar clinical signs.

Confirmation of toxin exposure using reference laboratory testing is not always available, but when it is, the diagnostic path is often time consuming and can delay the initiation of appropriate emergency treatments. Accordingly, an in-house screening test for common toxins would prove helpful to patients, veterinarians, and clients. Such a test would be the most valuable if it was capable of having a rapid turnaround time with the ability to test for multiple toxins at once.

Ethos Discovery has initiated a research plan to prioritize the toxins that prove the most problematic for patients.

The scientific approach to this research plan can be rapidly translated for use in human medicine as these patients may present with similar toxin exposures.

Following identification and validation of the platform with known toxin controls, clinical validation will be needed in clinical patients who are exhibiting clinical signs potentially associated with toxin exposure.
Diagnosing Disease: Pug Encephalitis and Exosomal DNA
Pug Encephalitis (a disease characterized by inflammation of the brain) is part of a family of rapidly progressive neurological diseases seen in younger small breed dogs. This condition shares genetic and other similarities to atypical forms of multiple sclerosis in human patients.

These conditions are not usually successfully treated, and do not have definitive, simple non-invasive diagnostic tests. Currently, the diagnosis is made when an MRI scan and spinal fluid analysis both fail to suggest either a tumor or infectious disease as causes for brain-related symptoms.

A blood test for this aggressive neurological disease of small breed dogs is needed. Based on experience with similar diseases in other species, it is reasonable to consider that changes in exosomal DNA will provide such a diagnostic test for affected dogs.

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