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Myriad’s reasoning for the secrecy is straightforward. Sharing "doesn’t make a lot of business sense," Meldrum said.
Myriad "is holding clinical testing back," said Evans, a board member for the American College of Medical Genetics and Genomics, a plaintiff in the Supreme Court case against Myriad. "There’s no medical, or rational, logic here."
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Runi Limary, 36, of Austin, Texas, found a cancerous lump in her right breast in 2005 when she was 28. She had that breast removed, followed by 14 months of chemotherapy and antibody therapy. She put off getting Myriad’s test because her insurance didn’t cover it until she changed jobs in 2007.
The gene test was less helpful than she had hoped.
She had a mutation in BRCA1 that Myriad had only seen in two other patients, she said, which meant that the company wasn’t sure whether it was harmful or not.
As a result, Limary is in limbo. She faces an agonizing decision soon, whether to get her ovaries surgically removed to prevent ovarian cancer, she said.
If Myriad’s database was public, and if there were more competitors doing the test, she might have received a definitive answer sooner on whether her tumor was due to a bad gene, she said. She is a plaintiff in the patent case against Myriad.
There are simply too many questions left about genetic testing to allow Myriad to control results affecting millions of women, Limary said. "It is very disheartening," she said.
Myriad is gearing up for what may be its biggest challenge -- defending its patents before the U.S. Supreme Court, which agreed on Nov. 30 to hear the case.
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In that suit, the justices are being asked to decide whether BRCA or other human genes that have been removed from the body are products of nature, and thus ineligible for protection, or whether isolating and purifying the genes from the body creates a patentable invention.
The 20 plaintiffs include patients, scientists and genetic counselors, professional groups representing more than 100,000 pathologists, geneticists and lab workers, and the consumer health organizations Breast Cancer Action and Our Bodies Ourselves.
The plaintiffs won the first round in the case in March 2010, when a federal judge invalidated parts of seven patents. An appeals court partially overturned that decision this past August, setting the stage for the Supreme Court to take the case.
The high court is expected to decide the Myriad case by next summer.
If the patents are upheld, they will remain in force until 2015, Meldrum said. The company also has an additional 17 patents on its BRCA testing that, so far, are unaffected by that lawsuit. They provide strong protection until 2018, and by then Myriad will have introduced a new test that combines BRCA with the other cancer risk genes, he said.
"As a pioneer you will take arrows," said Capone, the president of Myriad’s testing unit. "We have put the patient at the center of focus of the entire organization."
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