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Increased competition for BRCA testing following Supreme Court ruling

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Within a few days of the U.S. Supreme Court’s ruling in the Myriad Genetics patent case, Akron Children’s geneticists have already heard from other laboratories offering genetic tests for hereditary cancers at lower prices.

“The court’s decision was nuanced, but it certainly appears to have had the desired effect of opening the gate for more competition in research and genetic testing. We see this as a win for patients,” said Dr. Catherine Ward-Melver, a clinical geneticist.

In the closely-watched case, the Association for Molecular Pathology vs. Myriad Genetics, the court ruled unanimously on June 13 that the Utah-based Myriad did not own a patent on the BRCA1 and BRCA2 genes, where mutations can indicate significant likelihood of breast and ovarian cancer.

“Myriad did not create anything,” Justice Clarence Thomas wrote for the court. “To be sure, it found an important and useful gene, but separating that gene from its surrounding material is not an act of invention.”

Many consider this a landmark ruling.

Supporters of the decision say it will end one company’s monopoly on testing for the BRCA genes, spur more genetic research, and lower costs for consumers. Others worry that it may discourage investment into genetic research.

Dr. Catherine Ward-Melver

Dr. Catherine Ward-Melver

“Myriad charges more than $3,500 for testing of the BRCA1 and BRCA2 genes, and we have already received notice that another major lab is rolling out the same test for $2,200,” said Dr. Ward-Melver. “As more options become available, we will try them out and evaluate them based on multiple factors including price, turnaround time, customer service and patient-friendly billing policies.”

Dr. Ward-Melver added that some labs are taking the opportunity to offer new combinations of tests for hereditary cancer, which will lead to a larger selection to choose from based on a patient’s history.

Myriad has held the patent on the two genes for more than a decade, meaning patients had no other option even if they just wanted a second opinion to confirm they had the gene mutations and were at higher risk for breast and ovarian cancer.

The lawsuit against Myriad was filed by the American Civil Liberties Union in 2009 on behalf of researchers, genetic counselors, patients, cancer survivors, women’s health groups and scientific associations representing geneticists, pathologists and laboratory professionals.

Even as the court ruled that merely isolating a gene is not enough to earn patent protection, it said that manipulating a gene to create something not found in nature, such as synthetic DNA, is an invention and eligible for protection.

This aspect of the ruling is considered a partial victory for Myriad and other companies that invest in genetic research.

“Myriad has been effectively protecting its patents for years.” said Dr. Ward-Melver. “It will be interesting to see how companies interpret this ruling over time and which battles they decide are worth fighting. For now, it definitely seems as if other labs are feeling comfortable rolling out new test panels complete with billing codes and pricing. How that will translate into care of our patients will become clearer over time, but hopefully more options and competition will result in lower prices and better service.”