I had a lot of trouble deciding where to go for genetic testing so I sent this email to Pawprint Genetics when trying to sort out the information:
"Patent law is confusing and knowing who to trust in a highly unregulated industry is even worse. Can I really trust that you are running the tests for the mutations common to my breed? And if you are running the correct tests, why shouldn't I feel guilty for not going to the labs that put the money and resources into identifying the mutations originally? And are these tests simple PCR-based tests are do you actually sequence them- this last question is pure curiosity."
Here was the response (as of January 2016):
Regarding patent law, although I am not an expert, we have been through several cases. We settled with Auburn University and VetGen before the cases got too far down the road. You can read about those here:
Auburn University:
https://www.pawprintgenetics.com/news/stories/24/
VetGen:
https://www.pawprintgenetics.com/news/stories/3/
As the law currently states, one cannot patent a naturally occurring substance such as a natural DNA mutation and you cannot patent a naturally occurring phenomena such as that a DNA mutation causes disease. Unfortunately, the USPTO was not paying attention to the law that had been in place for many, many years and issued patents for nonpatentable subject matter. In 2012, the Supreme Court upheld the law in Prometheus v Mayo Clinical Laboratories and again in 2013 Myriad v AMP (this was the quite celebrated breast cancer case).
We sued for our rights to test Labrador Exercise induced collapse and on March 31, 2015, in Federal Court, the EIC patent was invalidated based on these Supreme Court decisions. You can read about that case here: https://www.pawprintgenetics.com/news/stories/26/
We are currently still in litigation with Optigen over the PRA-prcd and CEA tests. We anticipate an end to this case next month if things stay on track.
We have worked within the law to get these cases settled and in doing so, we have been able to continue to offer the tests until the lawsuits are settled or decided.
I understand you wanting to be loyal to the companies that found the mutations. In most cases, the companies did not use their own money to do the research, but rather relied on breed clubs and individual for donations and also received grants from organizations such as the National Institutes of Health, the Morris Animal Foundation and AKC. I can’t tell you what to do, but we are also engaged in research and pay for this research through donations and from our revenues. It is a company’s choice to engage in research, but the outcomes of this research belongs to those who paid for it and that is usually the tax payer or dog owner.
Regarding our methods, every method that we use starts with a PCR. We then use a variety of genotyping methods, size fragmentation gel electrophoresis and restriction enzyme digestions. The method depends on the type of mutation. Unlike all other canine genetic testing laboratories, to my knowledge, we are the only laboratory that looks at the mutation region in your dog twice, with two different methods.
I am the founder and CEO of PPG. I am a board certified geneticist by the American Board of Medical Genetics. Until PPG, I ran human genetic diagnostic laboratories for over 20 years. When my last company was acquired, I was able to follow my passion, genetics and marry that with my love of dogs and started PPG. We have on staff 3 PhD Geneticists and 2 Veterinarians (one of the vet also has her PhD in Genetics, so 4 total Laboratory Directors) and customer service representatives and molecular genetic technologists.
I was shocked to learn that there is no regulatory oversight in canine genetic testing. Coming from human genetics, a highly regulated industry, we decided to implement the standards that we knew from human testing. Thus, for each gene mutation, we look at your dog twice – we perform two independent tests with two independent methods for each mutation. This allows us to have the highest accuracy in the industry. Every result is reviewed by and every report is signed out by both a PhD Geneticist and a Veterinarian. Given that we test every sample twice with two independent methods for each gene mutation ordered and the fact that we have highly skilled laboratory directors reviewing and signing results, and that they are also available to speak with you on the phone, we maintain very competitive prices.
After reading the response, I decided to trust this lab for the time being. I am not endorsing them, but you have to trust someone and my scientific mind likes the fact that they understand what they should be doing. I can't prove they run two independent tests for every mutation, but at least they know enough to lie well if they aren't.
"Patent law is confusing and knowing who to trust in a highly unregulated industry is even worse. Can I really trust that you are running the tests for the mutations common to my breed? And if you are running the correct tests, why shouldn't I feel guilty for not going to the labs that put the money and resources into identifying the mutations originally? And are these tests simple PCR-based tests are do you actually sequence them- this last question is pure curiosity."
Here was the response (as of January 2016):
Regarding patent law, although I am not an expert, we have been through several cases. We settled with Auburn University and VetGen before the cases got too far down the road. You can read about those here:
Auburn University:
https://www.pawprintgenetics.com/news/stories/24/
VetGen:
https://www.pawprintgenetics.com/news/stories/3/
As the law currently states, one cannot patent a naturally occurring substance such as a natural DNA mutation and you cannot patent a naturally occurring phenomena such as that a DNA mutation causes disease. Unfortunately, the USPTO was not paying attention to the law that had been in place for many, many years and issued patents for nonpatentable subject matter. In 2012, the Supreme Court upheld the law in Prometheus v Mayo Clinical Laboratories and again in 2013 Myriad v AMP (this was the quite celebrated breast cancer case).
We sued for our rights to test Labrador Exercise induced collapse and on March 31, 2015, in Federal Court, the EIC patent was invalidated based on these Supreme Court decisions. You can read about that case here: https://www.pawprintgenetics.com/news/stories/26/
We are currently still in litigation with Optigen over the PRA-prcd and CEA tests. We anticipate an end to this case next month if things stay on track.
We have worked within the law to get these cases settled and in doing so, we have been able to continue to offer the tests until the lawsuits are settled or decided.
I understand you wanting to be loyal to the companies that found the mutations. In most cases, the companies did not use their own money to do the research, but rather relied on breed clubs and individual for donations and also received grants from organizations such as the National Institutes of Health, the Morris Animal Foundation and AKC. I can’t tell you what to do, but we are also engaged in research and pay for this research through donations and from our revenues. It is a company’s choice to engage in research, but the outcomes of this research belongs to those who paid for it and that is usually the tax payer or dog owner.
Regarding our methods, every method that we use starts with a PCR. We then use a variety of genotyping methods, size fragmentation gel electrophoresis and restriction enzyme digestions. The method depends on the type of mutation. Unlike all other canine genetic testing laboratories, to my knowledge, we are the only laboratory that looks at the mutation region in your dog twice, with two different methods.
I am the founder and CEO of PPG. I am a board certified geneticist by the American Board of Medical Genetics. Until PPG, I ran human genetic diagnostic laboratories for over 20 years. When my last company was acquired, I was able to follow my passion, genetics and marry that with my love of dogs and started PPG. We have on staff 3 PhD Geneticists and 2 Veterinarians (one of the vet also has her PhD in Genetics, so 4 total Laboratory Directors) and customer service representatives and molecular genetic technologists.
I was shocked to learn that there is no regulatory oversight in canine genetic testing. Coming from human genetics, a highly regulated industry, we decided to implement the standards that we knew from human testing. Thus, for each gene mutation, we look at your dog twice – we perform two independent tests with two independent methods for each mutation. This allows us to have the highest accuracy in the industry. Every result is reviewed by and every report is signed out by both a PhD Geneticist and a Veterinarian. Given that we test every sample twice with two independent methods for each gene mutation ordered and the fact that we have highly skilled laboratory directors reviewing and signing results, and that they are also available to speak with you on the phone, we maintain very competitive prices.
After reading the response, I decided to trust this lab for the time being. I am not endorsing them, but you have to trust someone and my scientific mind likes the fact that they understand what they should be doing. I can't prove they run two independent tests for every mutation, but at least they know enough to lie well if they aren't.
