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Sales have soared, fueled by patents which give Myriad a virtual monopoly on genetic testing for hereditary breast cancer in the U.S. About 227,000 American women are diagnosed with breast cancer every year and about 5 to 10 percent carry the mutant genes.
"Nobody else has built a half a billion-dollar business around tests for single genes," Peter Lawson, a New York based analyst for Mizuho Securities USA, said in a telephone interview. "They are the dominant player in the industry."
Myriad is also "far and away the most conspicuous and controversial" testing company relying on gene patents, said Duke’s Cook-Deegan.
Although Myriad provides accurate testing for mutations in BRCA1 and BRCA2, its exclusive right to test those genes limits laboratories and researchers in developing new tests, said King, the University of Washington geneticist.
In 2006, after it became clear that Myriad’s main test missed some BRCA mutations, Myriad angered geneticists and genetic counselors when it didn’t modify its main test to include those mutations.
Instead, it came out with a separate test, now priced at $700, to detect the additional BRCA mutations missed by the main test. Insurance companies didn’t cover the second test for years, and most women didn’t get it until recently, genetic counselors said. Some women who tested negative on the main test may wrongly think they don’t have a cancer-causing gene.
Kathleen Maxian thought she wasn’t at high risk for inherited ovarian cancer, because her sister, who’d had breast cancer, had undergone Myriad’s main test and was cleared.
She was wrong. When Maxian developed ovarian cancer in 2009, she was shocked to find out that her sister had undergone only one of Myriad’s available tests. If her sister had gotten the second part of the two-part test, Maxian would have known that she was also vulnerable to ovarian cancer as well as breast cancer.
"It was absolutely devastating," said Maxian, who said she would have gotten her ovaries removed and her cancer likely would have been prevented. "There are a lot of women out there like my sister and I ... we are time bombs."
It is standard practice to split up tests, and insurers’ refusal to pay for the second test put Myriad in a no-win position, said Mark Capone, president of Myriad’s testing unit. The company has provided the second test free to patients who meet certain family and personal history criteria.
In 2010, King and her colleague, Tom Walsh, devised a new test that looks at dozens of breast and ovarian cancer genes, including the BRCA genes. When the University of Washington introduced a commercial version of the test this summer including 40 genes, it had to remove the BRCA genes because of Myriad’s patents, she said.
Use of the broader screens would eliminate delays and confusion caused by having to take as many as three rounds of tests that need to be passed by insurance, and may involve sending different blood samples to multiple labs, said Ellen Matloff, who heads cancer genetic counseling at Yale Cancer Center in New Haven, Conn., and is a plaintiff in the case.
"Every time a woman dies of breast or ovarian cancer who turns out to have a mutation in BRCA1 or BRCA2, or any of the 20 or so sister genes, I feel in a way that it’s on us," King said in an interview. King is outgoing president of the American Society of Human Genetics, which has joined in amicus briefs with other organizations against gene patents. King recused herself from the discussions, she said.
Myriad is working actively on its own product to scan multiple cancer-risk genes at once, said CEO Meldrum. Although the new technology used for such tests is rapidly improving, it still is "not accurate enough now for clinical purposes," potentially leading to errors if used before it is perfected, he said.
Myriad also refuses to share genetic data collected from many thousands of women tested since 2004, eight years after the BRCA test was first marketed.
Scientists worldwide are moving to place mutation data into public databases to improve interpretation of genetic tests and reduce the number of women left in limbo with ambiguous results, said James Evans, a geneticist at the University of North Carolina at Chapel Hill. Even in well-known genes, there are thousands of possible mutations in different ethnic groups, and it’s not always obvious whether a mutation is harmful.
In one effort, 48 U.S. companies and university genetics labs have agreed to work together to put mutations into a government-run database, said Heidi Rehm, a geneticist at Harvard Medical School in Cambridge, Massachusetts, who is heading the project. Myriad hasn’t yet agreed to participate, she said in an e-mail.Next Page >
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