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Geneticist Wendy Chung of Columbia University Medical Center cites the example of three sisters who sent their DNA samples to Myriad for BRCA analysis several years ago. The result was ambiguous: the women had a “variant of unknown significance” so they elected to have prophylactic mastectomies in case the mutation was cancer-causing. The women were very unhappy when, years later, Myriad re-classified the variant as innocuous.
“I think we could have moved a lot faster if the country’s scientific brainpower could have analyzed patients’ BRCA” rather than rely on Myriad, said Chung. Independent scientists could have studied not only whether a variant is dangerous or benign but also whether that risk is modified by the presence of other genes - crucial information when a woman is agonizing over whether to have her breasts removed, she said.
Capone said Myriad was not familiar with Chung’s patients, but when a woman has a BRCA variant of unknown significance, the company recommends that she be treated according to her family history - aggressively if many close relatives have had breast or ovarian cancer, conservatively if not.
Myriad acknowledges that it has restricted what BRCA tests patients can get. For instance, since 1996 its standard test (which now costs $3,340) has looked for simple mutations in the BRCA genes, analogous to a misspelled word. Until 2006 it did not probe for large rearrangements in the DNA, which are analogous to moving big blocks of text from one page of a book to another.
The company, which has a market value of around $2.1 billion, has seen its shares fall about 13 percent since the Supreme Court decided on Nov. 30 to take up the case.
It won a similar case in Australia in February, when the country’s Federal Court ruled that Myriad and Melbourne-based Genetic Technologies Ltd had the right to hold a patent on BRCA1. Trial judge John Nicholas found the material could be subject to a patent because it could not exist naturally on its own, inside or outside the human body.
The Australian findings are unlikely to influence the U.S. case. Justice Nicholas said evidence presented in Australia was different to evidence in the U.S. case, and there were also different constitutional settings for patent laws.