Supreme Court ruling broadens BRCA testing options.

T he day after Mother's Day, actress Angelina Jolie wrote an op-ed in the New York Times revealing her decision to undergo a double mastectomy after learning that she carries a deleterious mutation in the BRCA1 gene. Jolie and women like her who have certain germ-line BRCA1 or BRCA2 mutations are at higher risk for breast and ovarian cancers. Jolie, whose mother died from ovarian cancer, said she wanted other women who may have a familial history of these cancers to be aware of their genetic testing options. She also highlighted that not all women can afford the $3,000 individual risk assessment the test offers. The predictive genetic test that screens for mutations in both BRCA genes has been available only through Utah-based Myriad Genetics, a molecular diagnostics company that holds patents on the BRCA genes. But the Supreme Court has lifted what was a monopoly on BRCA genetic testing, invalidating five of Myriad's BRCA patents. In a unanimous ruling on June 13, the high court deemed isolated genes natural phenomena that companies may not patent. Still, both plaintiffs and defendants announced that the ruling was in their favor. " The opinion is clear when it comes to isolated genomic DNA. The decision overturns the patent office's policy, " said Sandra Park, attorney with the American Civil Liberties Union, who was involved in the case. On the other side, Myriad announced that the decision still upholds 24 of its patents, including claims on methods to analyze the genes. " Those claims around BRCA analysis are strong, " said Ron Rogers, spokesperson for Myriad. But Park pointed out that if the company thought the rest of the patents would allow it to maintain a monopoly, Myriad didn't need to keep fighting the lawsuit. The ACLU filed the initial lawsuit against the validity of Myriad's BRCA patents in 2009, along with the Public Patent Foundation and medical researchers, clinicians, genetic counselors, patients, and cancer survivors. The case has been argued in several federal courts. The U.S. Patent and Trademark Office has already issued preliminary guidance on patent filings, stating that the Supreme Court decision would significantly change their policy in reviewing patent claims on naturally occurring DNA sequences. Broader Access The decision allows unrestricted research and options for genetic testing, researchers say. " I think it will open avenues for more research and testing for patients as the test becomes cheaper, " …