By Ardy Arianpour, Senior Vice President, Ambry Genetics
Concerned parties of every size and shape have all been waiting for years to see what the Supreme Court would determine with the big gene-patent case involving Myriad Genetics ($MYGN). In my organization, Ambry Genetics, we cheered the ruling, as did many others. At the end of the day, though, the biggest winner is not any particular company or organization, but the genetics, diagnostics and medical device industry, and especially patients, specifically women across the country.
Prior to this SCOTUS ruling, genetic testing for breast cancer was a monopoly, plain and simple. For decades, women could only go to one company, one brand and one laboratory for BRCA1 and BRCA2 testing. Myriad Genetics set the price at whatever level the market would bear, and with no market competition, that price was quite high: thousands of dollars, which was prohibitively expensive for many women.
Just weeks before the SCOTUS ruling, these tests were in the headlines when Angelina Jolie disclosed that she had undergone them, and that was actually fairly typical: The prices were so high that only the wealthy could afford them.
Put simply, Myriad's monopoly was bad for the health of American women. Those of limited means, who, for example, had immediate family members with breast cancer and wished to learn of their own level of risk, were faced with a stark financial choice: Pay for the necessities of life or pay thousands for a potentially life-saving test.
After his discovery of the polio vaccine, Dr. Jonas Salk was asked, "Who owns the patent on this vaccine?" His reply: "Well, the people, I would say. There is no patent. Could you patent the sun?"
Gene patents like BRCA always remind me of Salk's famous stance: behind humanity, for humanity.
The SCOTUS ruling is a milestone to be celebrated, by patients and industry alike. It represents a major victory for women across the country, and for industry. The ruling has an enormous impact on biotech and the way products will be launched, and it is really only the beginning.
Welcome to the genetics gold rush
It is indeed the dawn of a new day, an age of gene-testing freedom for women across the nation. Moreover, this ruling creates vast opportunities in industry. With the stroke of a pen, the floodgates of competition have been opened, creating a positive competitive dynamic as assorted players vie to deliver the most cost-effective, reliable BRCA testing packages. (Consumers should be cautious to only deal with CLIA-certified labs, but that's a topic for another venue.)
With lower prices will come rising demand, which will in turn spur the offering companies to innovate and scale their tests, in a variety of ways, stimulating further demand, in a virtuous circle. Most importantly, lives will be saved: both the lives of breast cancer patients and others, as well, because this ruling affects not only BRCA testing but also other genetic tests, particularly for rare disease.
Now, companies and scientists will have the opportunity to develop new products and tests to compete in the marketplace. Rather than one group being the only game in town, clinicians' and patients' decisions about testing can be made based on fundamental attributes that are a part of any marketplace, such as convenience, quality of brand, reliability and service. In terms of the testing and diagnostics players, this ruling instantly levels the playing field across the space, and at the end of the day, it is anyone's game to win.
This unanimous decision by SCOTUS will go down in history as a watershed moment, celebrated by breast cancer survivors and their advocates, and by those in the genetic testing and diagnostics industry who rise to the occasion and seize the opportunity to compete on a level playing field.
This is the beginning of a new era in genetics and genomics. Unshackled from the bonds of a patent monopoly, innovation and research will now grow exponentially, especially in the fields of next-generation sequencing technologies and diagnostics powered by Big Data genomics.
The floodgates of competition have opened, we are entering uncharted territory, and the genetics gold rush has officially arrived! A positive development, all around.
Ardy Arianpour is Senior Vice President of Ambry Genetics, a genetics and clinical diagnostics company headquartered in Aliso Viejo, California. He dedicates this piece to his mother, Fariba Arianpour, a breast cancer survivor.