“We won’t know the real-world impact until we see decisions in the cases that Myriad has filed against those now providing genetic testing for BRCA1 and 2,” agreed Rochelle Dreyfuss, professor at the New York University School of Law in New York, NY. “If Myriad wins, patients and clinicians will be in the same position they were before.”

The Supreme Court ruling “was not the end of the legal story here,” agreed James Evans, MD, PhD, who directs the Clinical Adult and Cancer Genetics Services program at the University of North Carolina at Chapel Hill. “Really, what we’re seeing is the mess created when these kinds of issues have to be decided in the courts. Stay tuned.”

Continue Reading

Expanded Choice

So far, at least, the results of the Supreme Court ruling are “easy to see,” said Dr. Evans, “expanded access and more choice for providers and patients.”

“We’re likely to see innovations driven by the competitive market that now exists for providing breast cancer predisposition testing,” Dr. Evans said. “I think that’s good for patients.”

New labs started offering BRCA testing the same day as the Supreme Court ruling. Others continue to enter the field of BRCA testing; more than 25 different tests are now available that include BRCA testing, Dr. Chung noted. These tests include multigene, all-exome, and whole-genome sequencing tests for breast, gynecologic, and other cancers, Dr. Chung and Dr. Evans explained. “Now we are able to increase the clinical utility of those tests, to identify for a larger percentage of women, what their risk is.”

With new testing services have come lower costs, Dr. Chung said. BRCA testing before the ruling cost around $3,000, but is now available for one-third of that cost, she said.

Alarmist Posturing

The dire warnings that were issued after the Supreme Court ruling about harm to the biotechnology industry have not come true, Dr. Evans said.

“It’s very clear predictions of doom were wrong,” Dr. Evans laughed. “That was alarmist posturing.”

But neither have concerns that gene patents fundamentally harm cancer research efforts proven to be more than theoretical, he was quick to add.

RELATED: How Will the BRCA Patent Ruling Affect Oncology?

Myriad’s attempt to patent the BRCA gene “very clearly impeded clinical availability,” Dr. Evans said. “But it’s important to be fair to Myriad. It’s safe to say they haven’t generally impeded research; indeed, they’ve cooperated in many efforts.”

“No question, there was the potential for basic research to be hurt, but whereas clinical access was clearly hurt by patent exclusivity, you cannot make that same case for research,” Dr. Evans told ChemotherapyAdvisor.com. “Most researchers simply ignored the patents and most patent holders did not enforce patents against researchers.”

Uncertainties Need to Be Worked Out

But Rogers reported that the newer labs have been slow—as slow as 3 months, he claimed—to get results back to clinicians and patients.

Dr. Evans said that’s simply not the case in his experience. “We have used two other major labs [GeneDx and Ambry Genetics], in addition to Myriad, for BRCA testing ever since the Supreme Court decision and we are getting back results within 2 weeks, just like when we send to Myriad. We have noticed no difference.”