NEW YORK (GenomeWeb) – Consumer genomics has taken off in recent years, with companies like 23andMe and Ancestry advertising their testing services on the radio and the subway. But the genomic revolution has not bypassed another important household member: man’s best friend.
Several companies in the US and Canada have been offering canine genetic testing services to dog owners, breeders, and veterinarians, and some of the consumer-facing providers have been marketing their tests through rescue shelters and communal dog runs. Similar to ordering a spit kit online for a human genomic ancestry test, buccal swab kits to determine a dog’s breed mix or genetic disease susceptibility are now readily available on the internet.
One of the largest providers, Mars Veterinary, which is part of the food company Mars, says it has run almost 800,000 dog DNA tests over the past 10 years, the majority over the last four years. Most of these tests were ordered by dog owners. Likewise, Canadian firm DNA My Dog has seen its business, which exclusively caters to dog owners, more than double over the last four years. And newcomer Embark Veterinary, which launched a consumer canine genetic test last year that is also markets to breeders, conducted in the tens of thousands of tests in its first year.
“As human genetics has really started to bubble up to the surface, and it's not as scary and foreign — you can go to your doctor now and get a genetic test for allergies and breast cancer genes, et cetera — the pet health trends are following that,” said Juli Warner, senior brand and corporate affairs manager at Mars Veterinary. In addition, dog owners, and millennials in particular, are spending more on their pets than ever before. “They really start to look at their pets almost as substitute children,” she said.
Other canine genetic testing providers that have traditionally catered mostly to dog breeders, such as OptiGen and Paw Print Genetics, have also witnessed increased demand for their assays and continue to add new tests to their menus.
But as dog DNA testing volumes grow and more companies enter the market, worries about a lack of standards to assure the quality of testing are increasing. In addition, patent litigation among the industry players has been rampant, as many canine DNA tests have intellectual property associated with them.
Probably the most common motivation for a dog owner to seek a DNA test for their pooch is to find out about its breed mix, which in the case of rescue dogs is often a mystery. “I would say the number one reason is just curiosity,” said Mindy Tenenbaum, president of DNA My Dog. Owners are also interested in the results because different breeds can be trained differently, she said, and because some breeds are more susceptible than others to specific genetic diseases. Another reason for breed testing is that owners may doubt the stated breed of their dog and want to confirm that what they were told is true.
An increasing number of dog owners are also interested in finding out about inherited diseases their dog might be at risk for, with the hope that they can be detected early or even prevented. Just this week, Mars Veterinary launched a new version of its Wisdom Panel consumer test, Wisdom Panel Health, that assays for more than 140 disease-causing mutations, in addition to analyzing a dog's breed composition. With that launch, Mars joins Embark and Paw Print Genetics, which already offer dog owners genetic health screens.
Mars Veterinary is one of the earliest players in consumer-targeted DNA breed testing. In 2007, the company launched its first breed test for the consumer market, called Wisdom MX, initially through veterinary clinics because it required a blood draw.
The analysis is based on work by researchers at the Fred Hutchinson Cancer Research Institute, led by Elaine Ostrander and Heidi Parker, that was published in Science in 2004. That paper describes the use of genetic markers to study the relationship between 85 dog breeds. Specifically, the researchers showed that they were able to use microsatellite markers to assign 99 percent of individual dogs to the correct breed. Mars holds an exclusive worldwide license to the breed analysis technology from the Hutchinson Institute.
Conceptually, the ability to identify a dog's breed from its genome is based on the lack of genetic diversity within a breed, resulting from a high level of inbreeding, said Bridgett vonHoldt, an assistant professor of Ecology and Evolutionary Biology at Princeton University who studies canine ancestry and evolution. "Their genomes are quite homogeneous," she said.
According to Warner, Mars Veterinary, a business unit of Mars Petcare that is based in Vancouver, Washington, soon discovered that veterinarians, having had little training in genetics, were ill-equipped to explain the breed DNA test to dog owners, so the company started to market it directly to consumers after a few years. Along with that came a change in sampling technology, which switched from a blood draw to a cheek swab.
In the meantime, the test has gone through several iterations. Wisdom Panel 4, which has a list price of about $85 and is only available from the company's website, tests for more than 250 dog breeds and varieties, plus wolf and coyote. The test, which has a turnaround time of two to three weeks, also includes a number of additional traits, two disease genes, and predicts a dog's adult weight. Wisdom Panel Health, which the company launched this week for about $150, includes more than 140 additional disease mutation tests.
The two disease gene tests included in Wisdom Panel 4 are for mutations in the Multi-Drug Resistance 1 (MDR1) gene, which are particularly common in herding dogs and can lead to severe adverse reactions to common drugs, and for mutations in the DNM1 gene that can cause exercise-induced collapse (EIC). Mars licensed the MDR1 test exclusively from Washington State University.
Wisdom Panel Health greatly expands the spectrum of genetic diseases tested for. Mars in 2015 teamed up with Finnish DNA testing firm Genoscoper Laboratories of Helsinki. "We work with them to develop the science around our disease testing," Warner said.
The Wisdom Panel test runs on an Illumina custom array and is conducted for Mars by Neogen GeneSeek in Lincoln, Nebraska, a large animal genetic testing company.
Outside the US, Mars offers Wisdom Panel in Canada, Australia, New Zealand, and the UK and has a distributor in Germany. It is also seeing a lot of interest from Asia, Warner said, and plans to expand its business to additional countries, though it has not decided which ones. The dogs it has tested already hail from all over the world, as people sometimes adopt dogs from far-away places.
Mars continues to improve the Wisdom Panel by adding more breeds to its panel, including those that are local to certain countries, for example in Europe or Asia, she added.
DNA My Dog
Another player in the consumer-oriented breed testing market is DNA My Dog, based in Toronto, Canada. The company started in 2009, initially as a distributor for BioPet Laboratories of Knoxville, Tennessee, which discontinued its breed identification business in 2011 after being sued by Mars for patent infringement.
According to Tenenbaum, DNA My Dog conducts several thousand tests per month, most of them breed identification tests, which sell for about $70 on its website. Initially, the firm marketed the test through canine rescues and shelters, she said, but increasingly, it has been selling it directly or through distributors.
The DNA My Dog Breed Identification Test, has a turnaround time of two weeks or less, and covers 94 breeds, which the company picked according to their popularity. It keeps adding breeds when they get popular or removes them if they fall out of favor, Tenenbaum said, adding that testing for a limited number of breeds is not necessarily a bad thing. "The more breeds are in there, the more room there is for error," she said. The company also sometimes adds breeds for specific markets — for example, it tests for Boerboel for customers from South Africa but not from North America.
Besides its main breed test, DNA My Dog offers a $157 version for owners who want to find out the breed of their deceased dog. "There are some people whose dog has passed away and they always wanted to know what their dog was, maybe to get closure," Tenenbaum said. That test, which the company conducts in partnership with the Paleo DNA Laboratory at Lakehead University, requires an item that was covered with the dog's saliva, such as a toothbrush or a chew toy. "Most of the time, but not all of the time, we're able to get a result," Tenenbaum said.
Another test the company offers as an add-on to its breed test, for a total of about $90, is a wolf-coyote hybrid test that determines whether a dog has any recent non-dog ancestors. This could be because the dog has come into contact with a wolf or coyote in the wild by accident, or through intentional breeding. Tenenbaum said the company does not support the purposeful breeding of hybrids, which she said results in dangerous animals, but the company has seen significant demand for a genetic test for hybrids.
While the bulk of samples tested by DNA My Dog come from the US and Canada, the firm has resellers in Germany, the UK, Israel, South Africa, Turkey, and Australia.
Attitudes toward canine DNA testing have changed over the years, according to Tenenbaum. “When we started, we would get so many people telling us that it was a scam and that there was no way you could tell the breeds of a dog through the DNA because they are so similar, and they all come from the grey wolf,” she said. “I would say, in the last four years or so, rarely would anybody say that.”
DNA My Dog operates its own laboratory and has used different test technologies, including microsatellite analysis and array-based copy number variant testing, but it does not disclose details about its current test methodology.
One of the reasons the company’s business has more than doubled over the last four years is that more people are getting a rescue dog instead of a purebred, Tenenbaum said, and they want to know what breeds are in their dog.
DNA My Dog is about to add a number of new tests to its menu, she said, including screens for genetic diseases and a size prediction test.
A more recent entrant into the canine genetic testing market is Embark Veterinary of Boston, which started offering its approximately $200 Dog DNA Test just over a year ago and has seen significant growth during that time, selling in the tens of thousands of tests in its first year.
This summer, the company raised $4.5 million from a number of investors, bringing its total funding to $6.5 million, and said that it plans to expand into the breeder market.
“What we offer is, in some sense, the 23andMe for dogs,” said Ryan Boyko, Embark’s CEO. He and his brother Adam, a professor in the Department of Biomedical Sciences at the Cornell University College of Veterinary Medicine, founded the firm in 2015. “We are the only company that’s offering kind of a research-grade microarray test with hundreds of thousands of genetic markers where we can do essentially the things that 23andMe is doing,” he said.
Embark's test, which has a turnaround time of six to eight weeks, combines breed identification with a look at a dog's ancestry, a number of traits such as coat and body features, and more than 160 genetic disease tests.
It tests for more than 175 breeds, which the firm says covers more than 98 percent of purebred dogs in the US. The test also includes a number of so-called village dogs from around the world, as well as species related to dogs, such as wolf, coyote, and dingo.
The test, which Embark outsources to an undisclosed CLIA-certified laboratory that also performs human DNA testing, is conducted on an Illumina microarray with more than 200,000 markers that Embark has designed.
Boyko said the company has been initially focusing on dog owners and breeders but plans to target veterinarians in the future. It already provides customers with a vet report that they can share with their veterinarian.
Going forward, the firm plans to add tests for a handful of additional genetic conditions that it is current validating. It is also building the next generation of its microarray, which will accommodate more tests, and it is working on establishing partnerships, including with pet insurance firms and pet care companies, Boyko said.
Embark also hopes to use its database in the future to contribute to canine disease research, through collaborations with academic research groups, and the overwhelming majority of customers have given the company permission to use their dog's data for research. "Our hope is that not only we will be discovering genes underlying conditions that we don't know yet but we will also be an important part of developing treatments for a lot of these diseases," Boyko said.
What's in my dog?
Companies offering breed determination tests rely on their own set of genetic markers, proprietary reference databases of purebred dogs, and custom analysis tools. "You have to have a sophisticated algorithm, you have to have a nice set of markers strategically placed, but you've also got to have a good breed count" in the database, said Warner.
"It is interesting that every company will have not only a different set of references but also a different set of markers," said vonHoldt. "Some will be SNPs, some will be microsatellites, some will be a mixture, some will have intron sequences, others will look at indels. There is a huge array in terms of the resolution of the genetic test, and usually, the number of markers is also fairly variable."
Mars Veterinary, for example, has amassed a database of more than 12,000 purebred samples from 250 breeds, types, and varieties — for example, different styles of dachshund — which it claims is the largest breed database in the industry. Warner said that for popular breeds, like the Labrador, several hundred purebred samples are needed because there is more genetic variation within the breed, whereas less popular breeds, such as the Borzoi, only require a few dozen samples as they are genetically less diverse. Overall, the company uses about 5,000 markers for both breed identification and disease detection.
"One of the humps we have to get over is, you cannot visually identify the breeds in a dog with any real accuracy," Warner said. The company has conducted studies, for example, showing that based on appearance alone, people guessed the breed mix of a dog accurately only about a quarter of the time.
DNA My Dog has assembled a database that contains up to 200 samples or so for each of the 94 breeds it tests for. For many breeds, it has collected samples from several dog populations, for example, French bull dogs from several breeders in the US, Canada, and the UK. “We’re really picky about that because if you didn’t have a purebred database, if it was off somehow, you would be completely wrong in your breed analysis,” Tenenbaum explained. The firm does not disclose details about the markers it uses, though.
Embark, on the other hand, has licensed a reference database from Cornell University, which it has been adding samples to, mostly dogs tested by the company that were certifiably purebred. Its database currently contains about 190 breeds but will increase to more than 200 in the near future, Boyko said. The company has also developed its own statistical algorithm for identifying the breeds, using more than 200,000 genetic markers. The analysis takes advantage of the fact that there is little divergence between dogs of the same breed, he explained, which often have stretches of hundreds of identical SNPs. If such a stretch is found in no other breed, it can be used to identify that breed.
While breed identification tests that target dog owners have only been on the scene for about a decade, and started to take off just a few years ago, canine inherited disease testing, which has traditionally targeted dog breeders, has been around for longer. This part of the industry is expanding, too, and some companies have expanded their business by selling genetic disease screens to dog owners. "It's growing by leaps and bounds," said Sue Pearce-Kelling, president and manager of OptiGen of Ithaca, New York.
OptiGen is celebrating its 20th anniversary this year. The Cornell University spinout was founded by Cornell College of Veterinary Medicine eye disease researchers Gus Aguirre and Greg Acland and human geneticist Jeanette Felix.
Initially, only a few commercial laboratories offered canine genetic disease testing, Pearce-Kelling said, but this has changed over the last few years. "A lot of these companies have spun off from human genetic companies," she said. "They didn't specialize in veterinary or canine inherited diseases but [see those tests as] more of an add-on."
OptiGen started offering its first test to breeders in 1998, a marker-based assay for a recessive mutation in a gene causing progressive retinal atrophy (PRA), an eye disease that is common in a number of breeds, including Portuguese water dogs, Labrador retrievers, and poodles. The disease-causing mutation, which is found in more than 25 breeds, was discovered in 2005 and OptiGen holds an exclusive license to a patent on the prcd-PRA test from the Cornell University Research Foundation.
In the meantime, the company has added almost 80 canine inherited disease tests to its menu, which each cost between $50 and $130, depending on type and volume. Many of these are for eye diseases, and the vast majority for autosomal recessive disorders. One exception is a test for a dominant version of PRA that occurs in mastiffs — if detected in an asymptomatic dog, owners can help prevent additional retinal damage by keeping the dog away from bright light, Pearce-Kelling said.
The majority of OptiGen's customers are breeders, and the aim of its tests is to detect disease carriers and to prevent the birth of puppies affected by disease. However, that does not necessarily mean all carriers of a recessive mutation should be eliminated from a breeding pool, as that might also get rid of favorable traits, Pearce-Kelling explained. "You don't want to willy-nilly remove what could be more than half of the population just because it's carrying a mutation," she said.
Avoiding two carriers from mating, on the other hand, "has allowed the breeders to keep a diversity within their population, and keep the various traits that in many cases they have been working on for many generations to achieve, whether it's temperament, or coat type, or behavior," she said.
OptiGen works closely with so-called parent clubs for different breeds, which she said typically have a health and genetics committee. What has changed over the years is that breeders have become more accepting of having disease carriers in their population. "There are many traits that go into the decision whether a dog should be bred, and who it should be bred to," she said, "and the test result is just one of them."
The company runs its own lab and offers its tests globally, primarily in North America and Europe, but also in South America and Africa. It has sublicensed several of its tests to Australian genetic testing firm Animal Network.
OptiGen, which does not disclose its testing volumes, also has associate laboratories in Europe that accept samples on its behalf and send them to its Ithaca laboratory. In addition, it has been doing a certain amount of cross-marketing with Mars Veterinary.
At the moment, OptiGen's assays are individual PCR-based tests, some of which run on a high-throughput platform, said Pearce-Kelling. Depending on the nature of the mutation, the company also uses other methods, including Sanger sequencing, but it currently does not run any of its assays on microarrays. "For the longest time, there have not been enough tests for a breed to make it cost effective," she said. "But as the price of the chips goes down, it becomes something to consider. Our biggest concern is accuracy and quality, but it is something we're looking at and would not rule out by any means."
OptiGen only offers its tests for breeds in which the disease and the mutation are known to occur. That is because the same mutation that causes disease in one breed may not be pathogenic in another, she said, noting that the prcd-PRA mutation, which occurs across many breeds, is very much the exception. Offering breed-specific tests also helps prevent confusion about which test is warranted, she added. While it would be possible to test for all disease variants on a chip at once, labs would need to be careful about how to report the results for different breeds. "In some way, it's much safer and more reliable to keep the test restricted to only those breeds where you know the mutation occurs and you know it has an effect," she said.
OptiGen continues to be involved in research, in collaboration with academic partners, to identify mutations causing canine inherited eye diseases, for example by reaching out to owners and breed clubs, and offering free testing for affected dogs. Current projects include, for example, research into inherited cataracts in Cocker spaniels, iris melanoma in Golden or Labrador retrievers, and various eye diseases in miniature and toy poodles. These efforts can lead to new commercial tests — for example, last month, OptiGen launched a new test for Type B PRA in the miniature schnauzer that came out of research conducted with its cofounder Gus Aguirre, who now works at the University of Pennsylvania.
Paw Print Genetics
A more recent player in the canine inherited disease testing market is Paw Print Genetics of Spokane, Washington, which was founded in 2012 by CEO Lisa Shaffer.
Shaffer came to the canine world from human genetic testing and is certified by the American Board of Medical Genetics and Genomics. In 2003, she co-founded Signature Genomics, which offered diagnostic pre- and postnatal microarray-based genetic disease testing, and served as its CEO until 2012. PerkinElmer acquired Signature in 2010 but decided to close the business in 2014. "I think I'm the only board-certified geneticist in the canine field," Shaffer said.
Paw Print Genetics offers about 150 genetic disease tests that customers can order individually or as part of a breed-specific panel. For example, for Labrador retrievers, it offers an "essential panel" for $315 that tests for seven disorders that are relatively common in this breed, such as exercise-induced collapse, and a "supplemental panel" for $320 that includes rarer genetic diseases, such as PRA Golden Retriever 2.
The company also offers tests for coat colors and coat traits, such as "curly hair," and provides parentage testing and DNA profiling to breeders and owners. Many of the coat traits have recessive inheritance, Shaffer explained, so they only become apparent when two carriers are bred together.
Like OptiGen, Paw Print caters mostly to breeders wanting to identify disease carriers in order to make sure they produce healthy puppies, though about 10 percent of its test orders come from veterinarians.
Educating customers about the different offerings is an important part of the business, Shaffer said. The company provides both pre-test counseling to make sure the right tests are ordered and post-test counseling to answer questions about the results. "I think that's a very important part of the service that we offer, and sort of a carry-over from human diagnostics," she said.
Furthermore, the company offers dog owners a $130 screening test called Canine HealthCheck that looks for 150 genetic diseases and traits. However, Paw Print points out that this is not a diagnostic test and advises customers to follow up with a confirmatory test if they receive a result that's of concern.
"For pet dog owners who have no idea what their breed is, going to a genetic screen like the Canine HealthCheck can be very helpful because we might uncover that the dog is at risk for something that's actually treatable," she said, noting that about 30 percent of the diseases on the panel have some kind of treatment. "So the pet owners can be proactive about their dog's health."
"But I don't think for a purebred dog it's necessary to do such a large screen," she said, similar to human genetic carrier screening, where a population-specific panel might be a better option than a broad panel. "If you know that all your ancestors are Ashkenazi Jewish, you don't really need to do some wide screen, you just do the Jewish panel," she said.
Paw Print runs its own laboratory and receives samples from all over the world, according to Shaffer. "There are very few countries we have not received a sample from," she said. Though the company does not disclose its testing volumes, she said that business has been "doubling every year" and continues to grow fast.
The lab employs at least five different testing platforms, including high-throughput technologies, that allow it to detect different types of genetic variants, but she declined to disclose specifics.
Paw Print is also working on expanding its testing menu. The company has approximately 50 new tests for inherited diseases and traits in development, Shaffer said.
Disease screening for breeders and vets
A couple of companies who have primarily been targeting dog owners so far have started to offer tests for breeders, too, and are beginning to target veterinarians.
Mars Veterinary currently offers a $130 test for breeders, called Optimal Selection Canine, that screens purebred dogs for more than 150 genetic diseases and a number of traits. It also measures diversity within the breed. "For some of the breeds that are narrowly bred, the diversity can be lower, and that can affect the outcome of the litter and the health of the litter," Warner said.
The advantage of offering a panel rather than individual disease tests is "that a breeder can come to the company and get everything in one fell swoop," she said. "Not all things we can test for are applicable to every single breed, but there are many that are applicable to lots of breeds, and certainly specific breeds."
Through its Banfield Pet Hospital and Royal Canin businesses, Mars also sells a Veterinary Test that requires a blood draw and combines breed detection and a screen for almost 150 genetic disease mutations.
Embark, for its part, also offers a version of its test for breeders, at a list price of $180, that includes breed-specific genetic disease risks, traits such as coat color and body size, and a measure of inbreeding. In addition, a section of its website is geared at veterinarians, though the company does not appear to offer a customized tests for vets at the moment.
Calling for standards
One feature that sets canine and human genetic testing apart is that there are no quality standards for diagnostic laboratories testing animal DNA in place. "There is no regulation whatsoever," Pearce-Kelling said. "You can set up your PCR machine in your basement and call yourself a veterinary diagnostic laboratory."
Incorrect test results can be the consequence of this lack of standards. "There are certain laboratories that unfortunately we find a lot of mistakes from," Shaffer said.
To change the current status, earlier this year, the International Partnership for Dogs (IPFD), a nonprofit organization founded in 2014 by a number of stakeholders, launched the Harmonization of Genetic Testing for Dogs initiative. The project aims to create an online resource with information about commercial providers and their tests, expertise and quality assurance, as well as expert reviews of dog genetic tests. It also plans to coordinate a program for proficiency testing and collect resources for genetic counseling and education.
Enforcing standards in the canine world will be a challenge, though. "If it starts out to be voluntary, but if the breeders are informed and are only going to go to laboratories that have these standards, then everyone will have to implement them, which I think is only good for the industry," Shaffer said.
In the meantime, several canine genetic testing labs have taken quality assurance into their own hands and promote their efforts to set themselves apart from competitors. OptiGen, for example, obtained ISO 17025 accreditation for its laboratory in 2012. It also archives DNA from all samples it receives for possible retesting, and it uses reference controls for its disease carrier tests, which Pearce-Kelling said not all laboratories have available.
Paw Print Genetics, for its part, decided to implement the same standards that are followed by CLIA-certified clinical genetic laboratories. The company inquired about actual CLIA certification, Shaffer said, but found out that this is not possible for animal testing laboratories. Following the CLIA standards means that it validates all tests it develops prior to launch and confirms each test result with an independent method, she said.
DNA My Dog currently does not see a need to seek formal certification for its lab. "We were thinking of doing it but we were told that it's not really worth our while because the certification would not do anything for us, it would not make [what we offer] a better test," Tenenbaum said. Keeping customers happy is enough of an incentive to provide high-quality test results, she said. "If you don't provide them with absolutely perfect results, you are dead," she said.
Dogfights about patents
Many canine genetic tests and analysis methods remain patented, and most commercial providers say they respect each other's intellectual property. This appears to be somewhat at odds with the human genetic testing field: Following the US Supreme Court decision in 2013 that human genes cannot be patented, in the case of the Association for Molecular Pathology v. Myriad Genetics, a number of human gene patents became invalid and the market for commercial genetic testing, notably the BRCA1 and 2 breast cancer genes, opened widely. Prior to that, more than 4,300 human genes had been patented.
OptiGen holds a number of exclusive and non-exclusive licenses to patents from the Cornell Research Foundation, the University of South Wales and the Border Collie Club of NSW in Australia, Uppsala University in Sweden, Merlogen, Antagene, Animal Health Trust, and Genetic Technologies, according to its website.
Since the Myriad case, Pearce-Kelling said, the patent situation has become "less stable" in the US compared to Europe, where canine genetic testing patents have been repeatedly upheld. "We continue to maintain the patents and pay hefty royalties and maintenance fees on patents, because we feel it's still a good investment, and the case law is not completely settled on this," she said. "And there are a variety of organizations that honor the intellectual property where it exists. We appreciate that. They are recognizing the research and development of these tests that led to the IP."
Mars Veterinary, for example, licensed all IP for its genetic disease tests, including the new Wisdom Panel Health. "Every patent-protected test we have in our tests we have licensed," Warner said.
OptiGen successfully asserted its patent estate several times prior to the Myriad decision. For example, in 2009, the firm sued several institutions and companies — including Texas A&M University, DNA Diagnostics, International Genetics, Genetic Fulfillment USA, and PinPoint DNA Technologies — over infringement of a number of its patents. This resulted in settlements in 2010 and 2012 under which the defendants stopped offering the offending tests. Also in 2012, OptiGen and French testing company Genindexe worked out a similar settlement. Another patent dispute, against Animal Genetics about the use of the prcd-PRA test, in 2011 also ended in a settlement in favor of OptiGen.
However, others have been challenging the status quo. "There might be a lot of patents in the dog world but they are not necessarily, in our view, valid," said Shaffer. "I don't know why the patent examiners are allowing these patents to go through. They are no different from human patents that have been invalidated."
When Paw Print opened its doors in 2013, "there ended up being a lot of lawsuits," she said, which the company sometimes fought back with its own. In late 2013, for example, it filed suits against VetGen of Michigan, which licenses IP for a canine test for von Willebrand's disease, and against Canine EIC Genetics, based in Minnesota, which licenses a patent to a exercise-induced collapse (EIC) test.
Paw Print reached a settlement with VetGen in early 2014, the terms of which were undisclosed, allowing it to offer von Willebrand disease testing. In the case against Canine EIC Genetics, a federal judge in 2015 declared the EIC patent invalid.
OptiGen also sued Paw Print in 2013, and the two parties reached a settlement last year under which Paw Print obtained an exclusive sublicense to OptiGen's patents for prcd-PRA, Collie eye anomaly, congenital stationary night blindness, and retinal dysplasia/oculoskeletal dysplasia in the US and Canada. Terms of that settlement were not disclosed, either.
Embark's Boyko declined to comment on whether the company has licensed IP for any of the 160 genetic mutation tests it offers, which include MDR1, PRA, and EIC. "We're confident that we're following the laws in the US," he said.
Companies focusing on breed identification, likewise, have been protecting their IP. Mars Veterinary, for example, in 2010 sued BioPet Vet Lab, PetSafe, and MMI Genomics over IP for canine breed identification to which it holds an exclusive license from the Fred Hutchinson Cancer Research Center. In 2011, Mars reached a settlement with BioPet and PetSafe, under which the two companies exited the canine DNA breed identification market.
Also, in 2012, Mars acquired the breed ID test formerly offered by Scidera Canine, which it said "stems in part from the resolution of a patent infringement suit brought by Mars associated with its Wisdom Panel canine DNA breed identification product."
The future of canine DNA testing
Genetics research in dogs remains an active field, which will likely expand commercial testing menus further in the future. The biannual International Conference on Canine and Feline Genetics and Genomics, for example, which took place in in Saint Paul, Minnesota in May, showcased new discoveries in both canine disease and behavior, according to Pearce-Kelling. "We're still very much catching up with the human genome in identifying disease mutations or risk variants," she said.
Genetic discoveries are also beginning to shed some light on dog behavior. "Why does a Retriever retrieve, why does a Pointer point? That's all genetic," Shaffer said. "I think eventually, canine laboratories will [offer tests for] a lot of behavioral traits, too."
VonHoldt, for example, is pursuing a patent for a PCR-based test for social behavior in dogs, based on a study she and her colleagues recently published that links structural variants in genes associated with human Williams-Beuren syndrome to hypersociability in dogs. "I think behavior has not really been tackled very much — finding genes that are associated with certain types of behavior," vonHoldt said. "And I think that is something people want to know about."
Besides genetic variants, epigenetic markers seem promising. Another patent vonHoldt's team is pursuing, for example, is for an epigenetic marker for aging in dogs. This could someday enable a blood test to estimate a dog's age, though she cautioned that more research needs to be done.