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The next frontier

The move toward biomarker testing is an example of the expansion of preventive, predictive, personalized and participatory animal health care.

The next frontier
Presence of a biomarker does not necessarily indicate presence of a disease.

Thought leaders in human medicine like Leroy Hood, Ray Kurzweil and Daniel Kraft have been talking about the four P’s of medicine for decades, but only recently have we seen a growing awareness of predictive, preventive, personalized and participatory forms of medicine within veterinary medicine. In particular, at the Veterinary Innovation Summit in April, Jon Ayers, Idexx Laboratories’ then-chairman and CEO, was discussing the market’s trending toward preventive care rather than acute and reactive care. Enabling preventive care is a proliferation of biomarker tests that are becoming more reliable and easier to access, both by the clinician and, in some instances, by the animal owner.

What Are Biomarkers?

Before we dig into direct-to-consumer, it’s worth spending a moment to understand how the term “biomarker” is being used and how this has worked well for one test in particular.

There is some debate about what a biomarker is or represents exactly. One of the most comprehensive definitions comes from the federal government’s “Biomarkers, EndpointS and Other Tools” resource: “A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention, including therapeutic interventions.”

This represents one of the broadest definitions of biomarkers and includes everything from proteins found in blood to toxicological exposure to interventions such as vaccine exposure, genomics, microbiome and imaging methods such as a PET scan. This broadened definition moves beyond those limited to biochemical and molecular measurements and incorporates a wider array of biomarkers that can be used in diagnosis and treatment.

In particular, by understanding the nature of the biomarkers associated with the microbiome, urinalysis and genomics, animal health professionals are in a better position to catch diseases in an earlier state because the associated biomarker tests are less expensive and less invasive than other tests, which might catch the disease state only when it is too late to provide anything other than pain management.

A recent successful example of biomarker identification is Idexx’s symmetric dimethylarginine (SDMA) test that provides “early detection of chronic kidney disease in cats and dogs for the early detection of chronic kidney disease in cats and dogs before the onset of increases in creatinine,” according to the Annual Review of Animal Biosciences. The presence of the biomarker SDMA creates an opportunity for earlier intervention and disease management.

SDMA tests are a great example of in-clinic predictive and preventive care applications, but other biomarker test examples involve not only predictive and preventive but also participatory. For example, Petnostics’ at-home urinalysis test kit features the same test strip a veterinarian would use in the clinic. It uses VET-10 Urine Reagent Strips, a collection cup and a smartphone app to analyze the test strip. Together, these provide the pet owner with a simple, inexpensive ($14.99), preventive and participatory form of wellness care that would help to identify the early presence of a disease. Although Petnostics uses the same test strips as in the clinic, they represent only part of the urinalysis picture, and some concern by veterinarians is warranted.

‘A Helpful Tool’

As with any new medical diagnostic, concerns have been raised about the validity and clinical application of such biomarker tests, especially those in the direct-to-consumer (D2C) category. For one, presence of the biomarker does not necessarily indicate presence of the disease. Because the biomarker, in some instances, could point to another disease, the biomarker itself should be used only as an early indicator that warrants further diagnostics. As Christine Mullin, DVM, DACVIM (Oncology), wrote in a VETgirl blog, “Undoubtedly, biomarkers will continue to emerge as a helpful tool within the diagnostic arsenal, particularly for diseases like cancer, but this single method of screening on its own will not and should not replace a complete physical and diagnostic examination.”

A related concern is the misguided perception of animal owners that they are performing definitive diagnostic tests and that they then can begin treating the condition using home remedies. As with all biomarker tests that function as early warning tests, further tests should be required. The value of early detection is not a definitive diagnosis but rather lies in less invasive, less expensive tests that might catch the early onset of a disease or help monitor that disease more regularly.

At-home DNA tests are another D2C category that has seen a lot of growth over the past five years. Products such as Embark and Wisdom Panel, which are for dogs, and BasePaws, which is for cats, offer pet owners the opportunity to easily collect a saliva swab, send it in for analysis and then receive the results electronically. The information provided includes breed type and genetic predisposition to certain diseases, such as polycystic kidney disease and dilated cardiomyopathy in dogs and hypertrophic cardiomyopathy in cats.

Although these DNA tests could be used as early prognosticators of disease, many animal owners apparently just want to understand more about the breed of their unspeaking housemates. Dr. David Haworth, talking at the fall Veterinary Innovation Summit at Colorado State University, said the relationship between the animal and owner is more of a pediatric relationship than a property relationship. Perhaps we could see DNA tests and the biomarkers they identify as an expression of pediatrics rather than of ownership.

Diagnose and Treat

Similar to the at-home urinalysis and DNA tests that engage participatory medicine, AnimalBiome’s at-home microbiome test engages dog or cat owners concerned about the gut health of their animal. A fecal sample is sent to AnimalBiome for DNA analysis of the gut bacteria. The results are compared to the company’s database of healthy guts to provide insight as to why the animal might be exhibiting signs of an unhealthy microbiome. AnimalBiome then offers nutritional supplements to try to restore a healthy microbiome.

The difference with a product like AnimalBiome’s microbiome test and supplement kit and the urinalysis and DNA test is that AnimalBiome goes beyond simple assessment and offers treatment options. Most of AnimalBiome’s examples involve situations where other testing mechanisms failed to produce healthy outcomes. The veterinary community is concerned about at-home biomarker tests that do not directly include a hands-on examination by a veterinary professional. The fears expressed by Dr. Mullin of operating in a biomarker vacuum could be echoed here.

Another example of participatory medicine that engages the animal owner in biomarker assessment is the wearable activity tracker. Initially thought of as a spillover from the human wearable market, with Fitbit being the most prominent example, the collars were little more than another way of measuring activity without providing much insight into the animal’s health. So what if Fluffy slept 18 hours a day? What does it mean for Fluffy’s health?

Things have changed. The Pet Insight Project, gathering data from the Whistle collar, has shown that activity levels on their own offer little insight into the health of the animal, but when the readings are combined with baseline historical data or information about recent surgical procedures or dermatological conditions and treatments, then the collar can go from being a passive recipient of information to an active part of health care. For example, recovery times from routine surgeries were normally thought to be five to seven days, but when the activity of thousands of dogs was measured, even routine surgical procedures were found to require up to 28 days before the dog acted normally again.

Also, trackers measuring activities such as scratching can determine when a potential flare-up of a derm condition might appear, allowing earlier intervention.

Part of the Veterinary Toolbox

Taken in isolation, each of these testing mechanisms could be seen as a novelty or something interesting to pet owners, but at the same time of little value to the veterinary community at large. Taken together, however, we can understand biomarker tests as an expression of a larger trend toward participatory and preventive care that is helping to get animals the health care they need sooner.

At-home urinalysis tests, DNA tests, microbiome tests and activity trackers can all provide helpful information for veterinarians to diagnose and treat diseases earlier than before, but only if they are aware of the products and can adequately assess their validity.

I read a blog post from a veterinarian who had a client arrive at the clinic with at-home urinalysis results. The vet was asking what colleagues had done in similar situations. I expected a response such as “Don’t bring that unproven stuff into my clinic!” I couldn’t have been more wrong.

The vast majority of respondents were cautiously optimistic about the test’s value. Though the test results weren’t enough to support a diagnosis, the vets were happy to engage the animal owner and get more tails through the door sooner.

We are entering an era in which people are more involved in their personal health care than ever before. The move toward biomarker testing is an example of the expansion of preventive, predictive, personalized and participatory animal health care. The veterinary industry would be wise to embrace at-home biomarker testing, if not because of the products themselves then at least because of what the products represent for better animal health care.

Innovation Station columnist Dr. Aaron Massecar is assistant director of continuing education at Colorado State University’s Translational Medicine Institute.

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