On June 13, 2013, the Supreme Court of the United States, in a 9-0 decision, ruled that Myriad Genetics could not patent the BRCA1 and BRCA2 genes.
Physicians and genetic counselors applauded the decision, as the company’s $3,300 sticker for its test meant that many uninsured and underinsured women were unable to afford testing for the genetic mutation that could significantly increase a woman’s risk for breast or ovarian cancer.¹
The decision by SCOTUS means that other companies will now be able to compete with their own versions of the test, which may not only be more affordable, but will also allow patients to get a second opinion before they undergo prophylactic mastectomies.
The Supreme Court’s ruling has implications for more than just testing for the breast cancer mutation. Sherri Bale, managing director of GeneDx, stated, “It levels the playing field. We can all go out and compete. This is going to make a lot more genetic tests available, especially for rare diseases.”²
Dr. Bale noted another example of the effect of the Court’s decision. The genetic mutation for deafness can also cause a skin disorder. GeneDx is allowed to test for the skin disorder, but if the genetic mutation for hearing loss is also discovered, they are not allowed to inform the physician. Instead, a separate specimen must be drawn and sent to Athena Laboratories, which holds the patent for testing for the deafness gene. The Court’s ruling will make this extra testing unnecessary.²
The decision also makes it possible to test for multiple diseases for the cost of the BRCA screen. Dr. Kenneth Offit, chief of the clinical genetics service at Memorial Sloan-Kettering Cancer Center, noted that many academic labs are planning to offer panel tests for up to hundreds of genes for the cost of Myriad’s test for two genes.²
Myriad plans to phase out the current BRCA test in 2015 and replace it with a test that examines 25 genes that contribute to breast and other types of cancer. The cost should be comparable to the current test.
This decision affected me personally. As a woman dealing with BRCA2 ovarian cancer, I was particularly moved by the press release from the Ovarian Cancer National Alliance, which stated:
As a voice for everyone whose life has been touched by ovarian cancer, we are grateful that the Supreme Court has ruled that naturally occurring DNA segments cannot be patented. Many women we work with are concerned about their genetic risk of developing ovarian cancer, especially in the wake of Angelina Jolie’s announcement that she carries the BRCA1 mutation. Myriad’s patent limited women’s options for learning about their genetic risk. Given the deadly nature of ovarian cancer, we are pleased with the Supreme Court’s decision, and hopeful that it will give women more options to learn about and safeguard their health.3
Do you know of someone personally or professionally who was not able to participate in this kind of genetic testing due to its cost?
- Doctors: Supreme Court BRCA gene patent ruling benefits patients, Los Angeles Times.
- After Patent Ruling, Availability of Gene Tests Could Broaden, New York Times.
- Press Release: Ovarian Cancer Advocates Praise Supreme Court Decision on Gene Patents, Ovarian Cancer National Alliance.