New study boasts 90% accuracy when using PARR to diagnose canine lymphoma

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Article originally published in NEWStat, an American Animal Hospital Association Publication 

Written by Tony McReynolds


Who measures the measurements? Who diagnoses the diagnostics? In short, who assays the assays?

Veterinarians have been using polymerase chain reaction for antigen receptor rearrangement (PARR), a readily available molecular assay that helps diagnose some kinds of canine lymphoma, for years. But no one really knew how accurate those assays were—because none have undergone a truly rigorous benchmarking study to determine the accuracy of PARR assays in general, regardless of the manufacturer.

Until now.

In a study published in the Journal of Veterinary Internal Medicine, Ethos Veterinary Health, Ethos Discovery, and the Translational Genomics Research Institute (TGen) found that their version of the test, called ePARR, was more than 90% accurate among a range of lymphoma sample types.

The results of the ePARR test study are based on an analysis of 180 dogs with cancer. The researchers used ePARR to confirm whether the dogs in the study had lymphoma and then to determine what type they had.

“We’re very excited about it,” Chand Khanna, DVM, PhD, DACVIM (Oncology), DACVP (Honorary), told NEWStat. Khanna is chief science officer of Ethos Veterinary Health, president of Ethos Discovery (a 501(c)3 independent not-for-profit incubator of scientific innovation), and co-senior author of the study.

Khanna emphasized that ePARR is not a new kind of assay but rather a new brand of assay, and the way it works to diagnose lymphoma isn’t different from what’s currently out there. He said the big takeaway here is the accuracy of the new study, which he calls “very rigorous.” He pointed out that the sheer number of dogs tested “well exceeds what has been done” in previous studies.

“What’s new is that doctors can offer [PARR assays] with a greater confidence in the performance of the assay than was possible before,” Khanna said.

Most dogs with lymphoma can be easily diagnosed using a simple microscopic evaluation of cells taken from the lymph node, so PAAR isn’t a first-line diagnostic test. However, a small minority of dogs yield tissue samples that display unusual features under the microscope, which makes some clinicians hesitant to begin treatment for lymphoma. In those cases, Khanna said, “you need a much more rigorous confirmatory test.”

PAAR, for example.

NEWStat asked Barbara Biller, DVM, DACVIM, retired associate professor of oncology at the Flint Animal Cancer Center at Colorado State University and practicing veterinarian at Boulder Road Veterinary Specialists in Lafayette, Colorado, what the study meant for veterinarians dealing with suspected cases of canine lymphoma.

“It’s further validation of [PARR],” Biller said. “We don’t need it to diagnose most cases of lymphoma but when we do need it, it can be really helpful. [The study clears up] some of the questions we have as far as how accurate it is for different samples.”

“This is the kind of data we need in this profession,” Biller added. “You have an organized, systematic evaluation of a technique. And it’s really good to see that kind of research.”

 

Read the article on NEWStat

TGEN-Ethos Study Underscores Need for Setting High Standards in Veterinary Cancer Diagnostics

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Written by Steve Yozwiak

PHOENIX, Ariz. — May 21, 2019 — Ethos Veterinary Health, Ethos Discovery, and the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, announced today that they have developed a highly accurate test for the diagnosis of canine lymphoma.

In a study published in the Journal of Veterinary Internal Medicine (JVIM), Ethos and TGen found that their test, called ePARR, was more than 90 percent accurate among a range of lymphoma sample types (link to the complete JVIM article is below).

TGen conducted genetic analysis of more than 180 dogs with naturally occurring cancer to confirm if they had lymphoma, and then determine exactly what type of lymphoma, which is a common and aggressive cancer in dogs.

“An ongoing need exists for robust validation of molecular diagnostics in veterinary medicine. This study is an example of exhaustive validation of one such molecular test,” said Dr. Will Hendricks, an Assistant Professor in TGen’s Integrated Cancer Genomics Division, and one of the study’s co-senior authors. “Overall, ePARR is more than 90 percent accurate across sample types and diagnostic settings.”

The study authors suggest that such tests could be even more accurate if testing facilities adopted more uniform testing techniques, established uniform high performance standards, and made their results more readily available to the general research community.

“In the veterinary diagnostic area, there is a need for methodological consistency and transparency. Each lab has their own methods for how to run the same test,” said Dr. Chand Khanna, Chief Science Officer of Ethos Veterinary Health, and also a co-senior author of the study. “Our validation of ePARR included over 180 dogs and a broad diversity of sample types, including cell pellets, air dried aspirates, and formalin-fixed paraffin-embedded tissues.”

Shukmei Wong, who is a TGen Senior Research Associate in the Hendricks Laboratory, who conducted the study experiments, and is a co-author of the study, said: “I hope this paper will inspire more reporting of assay methods and metrics, and help drive the creation of reference standards and more consistent protocols in diagnostics in veterinary medicine.”

Dr. Sam Stewart, Science Commercialization Fellow at Ethos Veterinary Health, agrees:

“It is truly unique to see such complete rigorous validation of a molecular assay in this field, and we hope this standard of transparency and quality will be followed by others. As a Critical Care doctor, I am proud to offer this high level of quality in a diagnostic assay to my patients.”

Molecular level investigations into dog DNA could someday not only improve the health of dogs with cancer, but also help contribute to a better understanding of cancer in humans, as well.

This study was funded by non-profit Ethos Discovery, which is evaluating options to make the ePARR test available to veterinarians and pet owners.

The study — Polymerase Chain Reaction for Antigen Receptor Rearrangement (PARR): Benchmarking performance of a lymphoid clonality assay in diverse canine sample types — was published April 2 in the Journal of Veterinary Internal Medicine.

No dogs were harmed during this research. Only tissue samples from pet dogs with naturally occurring cancers were examined.

 

Related Links:

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About Ethos Veterinary Health

Ethos is a veterinary health company with hospitals across the U.S. providing advanced medical care for pets. Our approach includes a focus on transformative science, continuous learning, growth for team members, and the development of collaborative relationships. For more information, visit ethosvet.com.

About Ethos Discovery

Ethos Discovery is a 501(c)(3) non-profit incubator of scientific innovation that seeks to improve health outcomes in pets and humans with complex medical problems, including cancer. For more information, please visit ethosdiscovery.org.

About TGen, an affiliate of City of Hope

Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life-changing results. TGen is affiliated with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases: www.cityofhope.org. This precision medicine affiliation enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes and infectious diseases through cutting-edge translational research (the process of rapidly moving research toward patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and complex rare diseases in adults and children. Working with collaborators in the scientific and medical communities worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process.

For more information, visit: www.tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen

Media Contact at TGen:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
syozwiak@tgen.org

Clinical Trial: To evaluate a new therapy for cats with anemia due to chronic kidney disease

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Ethos Veterinary Health is conducting a fully funded, FDA-regulated study to evaluate new therapy for cats with anemia due to chronic kidney disease.

We are currently enrolling cats in a study at a number of our hospitals involving the use of a unique gene therapy product. Products based on similar technologies (but not for this indication) are approved for use in human medicine in the U.S. and Europe, but this type of novel product has not yet been used for treating cats, making this an exciting treatment option.

Study Eligibility and Details:

  • Cats must be at least two years old and weigh at least 2 kg.
  • Eligible patients must have IRIS staged CKD and hematocrit of <28%.
  • The treatment is administered once by intramuscular injection at the beginning of the study (Day 0) and cats are monitored regularly for 70 days thereafter.
  • The study will include a placebo treatment group. Cats will be enrolled at a ratio of one placebo-treated cat for every four active-treated cats. Although the cats assigned to the placebo treatment group may not show improvement of their signs of anemia, they will still receive the benefit of free veterinary care and laboratory testing during the study.
  • Cats will receive physical exams, regular clinical pathology assessments and treatment at no charge to the client over the period of their participation in the study.
  • Owners who comply with study requirements will be compensated for costs associated with study.

Clinical Study for cats with chronic kidney disease

Enroll Today:

If you are interested in participating in this study, please refer to the list below and call the Ethos Veterinary Health hospital near you to learn more, or to schedule an appointment for a consult.

  • Boston West Veterinary Emergency & Specialty, Natick, MA: Dr. Hathaway Fiocchi, 508-319-2117
  • Bulger Veterinary Hospital, North Andover, MA: Dr. Annalisa Prahl, 978-682-9905
  • Capital District Veterinary Referral Hospital, Latham, NY: Dr. Shelley Smith, 518-785-1094
  • Massachusetts Veterinary Referral Hospital, Woburn, MA: Dr. Marion Haber and Dr. Kenneth Palladino, 781-932-5802
  • Port City Veterinary Referral Hospital, Portsmouth, NH: Dr. Karen Campbell and Dr. Tonya Brown, 603-433-0056
  • Premier Veterinary Group, Chicago, IL: Dr. Katie Simpson, 773-516-5800
  • Veterinary Specialty Hospital – Sorrento Valley, San Diego, CA: Dr. Kate Arnell, 858-875-7500
  • Vista Veterinary Specialists, Sacramento, CA: Dr. Nathan Bailiff, 916-231-4445

 

CLINICAL TRIAL: Protocol No.  VC-014

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A randomized, blinded, placebo-controlled field study to determine the efficacy and safety of TANOVEA®-CA1 (rabacfosadine for injection) in dogs

Sponsor: VetDC, Inc.

TANOVEA®-CA1 (rabacfosadine for injection) is the first and only FDA conditionally approved drug for the treatment of lymphoma in dogs.  This pivotal study is intended to provide the data to demonstrate substantial evidence of effectiveness as well as additional safety information in support of full FDA approval.

VC-014 is a randomized, multi-center, double-blinded, placebo-controlled study evaluating TANOVEA®-CA1 (rabacfosadine for injection) administered every three weeks for up to five treatments in dogs with lymphoma (either previously treated or untreated).    In order to participate in the study, dogs must meet eligibility criteria described in the protocol.  The study is fully funded by the Sponsor, and owners will be offered a clinic credit towards additional treatment in the event of disease progression.  

Contact Dr. Brenda Phillips, Veterinary Specialty Hospital, at 858-875-7500 with any questions.

Clinical Trial: Novel Pain Management Therapy in Dogs with Severe Elbow Dysplasia

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A Funded Clinical Trial to Evaluate a Novel Pain Management Therapy in Dogs with Severe Elbow Dysplasia

Trial Specifics

This study is designed to evaluate the tolerability, safety and effectiveness of a novel therapy (not yet approved by FDA) to manage pain associated with moderate to severe elbow dysplasia and secondary osteoarthritis in dogs. The investigational drug is administered as an intra-articular injection into both elbows. There is no placebo treatment.

The one-time treatment will be administered under sedation or general anesthesia to approximately 28 client-owned dogs. Owners are required to complete periodic pain assessment surveys and record short at-home videos assessing the dog’s gait. The study staff will train owners on how to complete the assessments.

The dog’s activity also will be tracked through the use of an activity monitor worn on the dog’s collar. Study visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 14, 28, 56, and 84.

Medications targeted at the treatment of osteoarthritis / elbow dysplasia pain, except for CBD and other cannabinoids, are acceptable, provided they have been administered for at least 2 weeks prior to enrolling in the study.

Trial Funding

The study is fully funded for its entire duration (approximately 84 days). Funding includes: the initial consultation, the study treatment and administration, radiographs prior to treatment (if not already performed within 2 weeks of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to study participation.

Trial Eligibility

Trained veterinarians at the trial sites will evaluate each dog for eligibility.

Dogs are eligible if they meet the following inclusion criteria:

  • Dog’s body weight 10-50 kg
  • Dog has clinical signs and radiographic evidence of elbow dysplasia
  • Dog is experiencing elbow-associated pain that is refractory to standard pain management or owner opts for pain management that is distinct from conventional treatments

Dogs are not eligible if they meet any of the following exclusion criteria:

  • Dog has a life expectancy of < 3 months
  • Dog has any underlying disease that will affect the study objectives or patient safety
  • Dog has concurrent or prior immune-mediated or other disease resulting polyarthropathy
  • Dog is impaired due to neurological disease or other orthopedic disease
  • Dog is pregnant or lactating
  • Dog is participating in another study
  • Dog may be unavailable for the entire trial duration or is felt to be unsuitable by the investigator for any other reason
  • Dog requires medications or supplements during the course of the study that interfere with the objectives of the studyincluding but not limited to TRPV1 agonist or antagonist drugs that could interfere with RTX mode of action (such as cannabinoids like CBD and anandamide).

 

Contact:

Please contact Dr. Sean Aiken, DACVS at 858.875-7500.

First-Ever, Nationwide, Multicenter, Prospective Study of Canine Splenic Hemangiosarcoma

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Cutting Edge Cancer Research in Veterinary Specialty Practice: Ethos Veterinary Health Completes First-Ever, Nationwide, Multicenter, Prospective Study of Canine Splenic Hemangiosarcoma

Woburn, Mass. — Jan. 15, 2019 — Ethos Veterinary Health (Ethos) has completed the patient accrual phase of their new Canine Hemangiosarcoma Molecular Profiling (CHAMP) study.

Hemangiosarcoma is one of the most malignant forms of cancer in dogs and CHAMP is the first nationwide, multicenter, prospective study of canine splenic hemangiosarcoma, which is a cancer of the blood vessels often affecting the spleen.

“Ethos is proud of this unprecedented milestone and of our investments in innovation that will improve outcomes for our patients,” said Ames Prentiss, CEO of Ethos Veterinary Health.

The clinical description of this population of dogs with splenic tumor rupture, a common diagnosis made on an emergency basis, is expected to be submitted for publication before the end of Q1 2019 by Dr. Sam Stewart, DACVECC and colleagues at Ethos.

“I expect the CHAMP study to change many misperceptions of hemangiosarcoma in the veterinary community, and ultimately help pet owners and veterinarians make better decisions regarding treatment,” said Sam Stewart, DVM, DACVECC, Science Commercialization Fellow at Ethos Veterinary Health.

The study also provided state-of-the-art care to dogs with splenic tumor rupture over a 12-month period and allowed for the collection samples for molecular analysis. CHAMP will result in a molecular characterization of genomic alterations in canine hemangiosarcoma which will help identify dogs with distinct prognoses and potentially life-saving molecularly-targeted therapies. Publication of these genomic data is expected in Q2 2019.

“When viewed from the perspective of a veterinarian trained to treat cancer – I am a veterinary Oncologist – the new genomic analysis of this highly aggressive cancer has already provided an opportunity for me to treat dogs differently,” said Chand Khanna, DVM, PhD, DACVIM (Onc), Chief Science Officer of Ethos Veterinary Health. “We are very excited to now launch clinical trials that will assess these new treatments and change outcomes for dogs with this very aggressive cancer.”

A critical component of this prospective study will be the molecular characterization of the disease recently completed through a collaboration of Ethos and The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. This Ethos-TGen collaboration allowed for the use of advanced next generation sequencing technology of tumor and blood samples collected from the CHAMP dogs.

Will Hendricks, Ph.D., Assistant Professor, Integrated Cancer Genomics Division of TGen, added: “The results of this collaboration between TGen and Ethos will bring needed evidence to the field of molecular and precision medicine. We are not only excited about the application of these data to dogs, but also to human patients with very similar cancers as part of a comparative approach to cancer biology and therapy, so-called comparative oncology.”

These new trials will open through Ethos practices in Q2 2019. In parallel, additional studies are ongoing to develop a molecular diagnostic to help define the prognosis of individual dogs and identify optimal molecularly derived treatments for each patient.

 

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About Ethos Veterinary Health

Ethos is a veterinary health company with hospitals across the U.S. providing advanced medical care for pets. Our approach includes a focus on transformative science, continuous learning and growth for team members and collaboration. For more information, visit ethosvet.com.

About Ethos Discovery

Ethos Discovery is a 501(c)(3) non-profit incubator of scientific innovation that seeks to improve health outcomes in pets and humans with complex medical problems, including cancer. For more information, please visit ethosdiscovery.org.

About TGen, an affiliate of City of Hope

Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is affiliated with City of Hope, a world-renowned independent research and cancer and diabetes treatment center: www.cityofhope.org. This precision medicine affiliation enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes, and infectious diseases, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.