On June 13, 2013, after many years of argument, the Supreme Court of the United States ruled that naturally occurring human DNA cannot be patented. The ruling on gene patenting stems from the case involving Myriad Genetics, the company that has held patents on the BRCA1 and BRCA2 genes. Mutations in these genes are linked to significantly increased risk for breast and ovarian cancer. During the time that these patents were in place, all clinical testing of the BRCA1 and BRCA2 genes was completed at the same laboratory.
Within hours of the Supreme Court ruling, multiple laboratories announced availability of BRCA1 and BRCA2 testing, giving health care providers and patients a range of options.
While many in the biotechnology field are not surprised by this ruling, or by the rush of laboratories to offer competitive testing, it creates some challenges for health care providers and patients making decisions about BRCA1 and BRCA2 testing.
One issue lies in the interpretation of genetic test results, a complicated process that depends on available data and some amount of comparison with sequencing results from other patients and families. With two decades of proprietary data available for their use, Myriad Genetics continues to have some advantage in interpreting results of testing.
Open access initiatives exist to help combat this problem. Researchers and health care providers have been contributing information about BRCA1 and BRCA2 mutations to the Breast Cancer Information Core, an international open access database, since shortly after the BRCA1 gene was identified in 1993. A recent initiative called Free the Data was launched to encourage patients to share their personal mutation information in an anonymous format as part of the larger ClinVar program at the National Center for Biotechnology Information. Even with these open access initiatives however, it may take years to collect a data set equivalent to that held by Myriad Genetics.
Myriad Genetics has also developed contracts and relationships with many national insurance programs over the past several years, and has provided effective preauthorization services for many patients pursuing BRCA1 and BRCA2 testing. Many of the labs now offering BRCA1 and BRCA2 testing are quickly developing similar contracts, making their services just as competitive, and in some cases less expensive.
While the Supreme Court decision has opened up a competitive market allowing for more choices for BRCA1 and BRCA2 testing, health care providers and patients will need to be increasingly thoughtful regarding the benefits and limitations of choosing one lab over another, weighing the value of experience, efficiency, quality and cost.
The University of Michigan Cancer Genetics Clinic provides counseling for people with a personal or family history of cancers that may have genetic links. If a link is confirmed, our specialized physician and genetic counselors will develop a plan for additional screening or lifestyle changes to help reduce cancer risk.
The University of Michigan Comprehensive Cancer Center’s 1,000 doctors, nurses, care givers and researchers are united by one thought: to deliver the highest quality, compassionate care while working to conquer cancer through innovation and collaboration. The center is among the top-ranked national cancer programs, and #1 in Michigan for cancer patient care. Seventeen multidisciplinary clinics offer one-stop access to teams of specialists for personalized treatment plans, part of the ideal patient care experience. Patients also benefit through access to promising new cancer therapies.