Four years ago today, in a landmark decision, the Supreme Court of the United States, in a unanimous 9-0 decision banned gene patents. What has changed in the genomics world in these past four years? And what changes are yet to come?
- Within 5 hours of the decision, laboratories began offering genetic testing for mutations within the BRCA1 and BRCA2 genes at half the $4400 price that the commercial laboratory, Myriad Genetics (defendant in the Supreme Court case), that held the patent had been charging.
- Multiple laboratories began offering BRCA1 and BRCA2 testing as a part of large cancer panels that included many other cancer genes. This pushed the entire field of genetics into a new era of panel testing, which aided in the detection of mutations that wouldn’t have been tested for/found previously, and will contribute to our understanding of risk associated with each gene.
- All new laboratories began sharing their data in public databases. (Learn more about the significance of data sharing in genetic testing.)
- The percentage of results with unknown meanings (known as variants of uncertain significance (VUS)) in these public databases decreased significantly, improving result interpretation.
- Some insurance companies began favoring laboratories that shared data.
- The cost of cancer genetic testing dropped to $249 by one lab, making self-payment an option for many consumers.
- The criteria for cancer genetic testing widened.
Sandra Park, Senior Staff Attorney at the American Civil Liberties Union (ACLU), weighed in on the impact banning gene patenting has had, "The Supreme Court win removed a huge barrier to patient access to genetic testing, the development of new and more comprehensive tests, and genetic research. As genetic testing becomes more commonplace, it is even more crucial to ensure that patients are empowered to make the best decisions for themselves and their families and to shape the course of genetic research. On the legal and policy front, the ACLU is committed to advancing patients’ rights to genetic privacy, which includes the right to obtain one’s own genetic information after testing and protection from genetic discrimination."
The BRCA patents were abolished within a month of Angelina Jolie’s public disclosure that she carried a BRCA mutation and had chosen to have both breasts removed preventively. The combined news coverage from these two events increased knowledge about cancer genetic testing and boosted interest in testing.
"The increased volume of patients having testing and the relatively small number of cancer genetic counselors nationwide led many providers to take on the role of ordering and interpreting genetic tests," our CEO/President, Ellen Matloff, who was also a plantiff in the case, shares. "This is occurring while result interpretation is growing more and more complex because more genes are added to panels. Concurrently, many cases of result misinterpretation have been reported, resulting in unnecessary surgeries and/or advanced cancer diagnoses for patients and their families."
Widespread result misinterpretation has underlined the need for accurate genetic counseling as part of the genetic testing process. This need for accurate genetic counseling will continue to intensify as mutations and VUS in rare genes are identified, and as we find more common mutations in families that do not have the expected cancer histories we see in more traditional cancer families. My Gene Counsel has created a digital, scalable genetic counseling solution that will help to solve this problem.