Tory Galloway thought her negative result on a widely-used test sold by Utah-based Myriad Genetics Inc. cleared her DNA as a cause for her fallopian tube cancer.
She happily advised her four sisters that the disease didn’t result from a family trait. The relief from the December 2010 test, though, was short lived. In October, after getting results from a broader scan at the University of Washington that included dozens of genes, she learned the truth: Her cancer was caused by a mutation that wasn’t included in the Myriad product.
"It makes me nuts to even think about it," said Galloway, a landscape designer in Indianola, Wash.
The broader test, created by University of Washington researchers, uses technology to identify as many cancer risks as possible. There’s one problem: Such a test can’t include the BRCA1 and BRCA2 genes that are the most common inherited causes for breast and ovarian cancer because Myriad owns the patents on them. This prevents other U.S. laboratories from using them in a commercial test.
In the mid-1990s, Myriad helped kick-start the gene-testing revolution by pinpointing the two BRCA genes. Now, the world’s biggest genetic testing company for breast cancer, with a market value of $2.2 billion, is under attack by researchers, genetic counselors, doctors, and their patients.
Besides stifling competitors from offering combination tests, including the BRCA genes, critics also said the company won’t share data from decades of testing that could aid research into how best to interpret screening. They said Myriad doesn’t adequately respond when other researchers find added BRCA mutations that address risks their current tests don’t cover.
"What is at stake is the way we want our health-care system to work," said Robert Cook-Deegan, a professor of public policy, biology, and medicine at Duke University in Durham, North Carolina, who supports limits on gene patents. "The testing has been set up by Myriad to optimize this business model. It is not set up to optimize public health outcomes."
The dispute, which has grown in intensity as more and more cancer-causing mutations are found, has spilled out of the laboratories and clinics into the U.S. Supreme Court. A ruling next year in a case challenging Myriad’s hold on the BRCA patents could either support the company’s profit-driven motives or redefine a nascent industry in a way that affects millions of dollars in revenue.
Myriad officials reject the criticisms, saying they offer faster, more accurate testing for harmful mutations in breast cancer genes than any other laboratory in the world, and that its patents haven’t hindered research or patient care.
"Myriad has never done anything to harm patients," CEO Peter Meldrum said during an interview at his company’s headquarters in Salt Lake City. "We have the most accurate results, we give the fastest results." There has never been a reported case in which Myriad wrongly told that a woman she had a cancer-causing mutation, he said.
Carol Mackoff, 70, a Chicago-based managing director for Rice Financial Products Co., says Myriad "saved my life."
Mackoff tested positive on a Myriad test for a BRCA1 mutation in 2002 after visiting an ovarian cancer prevention program at Northwestern Memorial Hospital in Chicago, she said in a telephone interview. Within weeks, she had her ovaries removed to prevent ovarian cancer, and later in 2009 had a prophylactic double mastectomy.
Without the Myriad test, "I would have had cancer," she said. "The fact that they developed these tests and gave me a tool to work with to allow me to prevent getting cancer, I owe them everything."
Faster, cheaper DNA testing is revolutionizing medical care. Nowhere has the impact been felt more strongly than in breast cancer. A woman who tests positive using Myriad’s tests carries as much as an 80 percent chance that she will get breast cancer in her lifetime. Testing helps women take charge of their medical future, providing options that can include preventative surgery and more extensive monitoring.
Widespread use of the tests has made Myriad an unabashed financial success. The company’s testing business, led by its flagship $3,340 BRCA product, carries an 87 percent gross profit margin that in fiscal 2012 generated $496 million in sales, according to Myriad.
That’s helped boost the company’s shares 30 percent this year.
Meldrum and Utah researcher Mark Skolnick founded Myriad in May 1991, about a year after Mary-Claire King, a geneticist now at the University of Washington, stunned the scientific world by proving that a single gene can raise the risk of breast cancer. Skolnick is retired from the company.
Backed by venture capital money, Myriad beat King and her academic colleagues to pinpoint the location of the BRCA1 cancer gene and patent it. They won a similar race to find another gene linked to increased risk -- BRCA2. Myriad filed a patent application for that cancer gene just days before a British-led team published a scientific paper announcing they had found it.Next Page >
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