ICARE Newsletter Summer 2013

BRCA Testing: Supreme Court Update

In a landmark decision regarding the patenting of human genes on Thursday June 13, 2013, the Supreme Court of the United States unanimously ruled that human genes may not be patented. The case specifically concerned the BRCA1 and BRCA2 gene patents, held by the Utah-based company, Myriad Genetics. In the ruling, Justice Clarence Thomas wrote for the court: “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” As a result of this ruling, it is widely believed the cost of testing (currently over $4000 for full gene sequencing and large rearrangement testing when performed through Myriad) will decrease, there will be opportunities for second opinions, and innovation pertaining to BRCA testing may be enhanced. Immediately after the decision, several companies (e.g., GeneDx, Pathway Genomics, Quest Diagnostics, Ambry Genetics, DNATraits, and University of Washington) announced plans to launch tests that include the BRCA genes, at a cost as low as $995.