By Susan Elan
Thursday, December 10, 2009
Patients and scientists are heading to federal court to challenge a company's right to a monopoly on diagnostic tests for genes linked to hereditary breast and ovarian cancer. The case could have profound consequences for genetic research in general.
In the last three years, Emory's molecular genetics laboratory has developed new gene sequencing tests for more than 200 rare genetic diseases, many of which were previously unavailable as clinical tests.
The cost of developing alternative diagnostic tests for the BRCA genes would be "relatively trivial," probably not exceeding several tens of thousands of dollars, Ledbetter estimated.
But the genetic diagnostics program Ledbetter heads at Emory can only invest in research for new tests when no gene patent or exclusive licensing agreement creates a monopoly. Ledbetter said he would conduct research to develop an alternative diagnostic test if Myriad's BRCA genes patents were invalidated.
"We would shift our research and development priorities to improve test performance and look for ways to make tests that are more cost effective, while offering as good or better services than any currently available," he said.
Instead, Ledbetter's group spends time and energy fundraising to pay for BRCA tests for women who come to Emory but do not have insurance coverage or the $3,500 that Myriad charges per test.
Ledbetter said about $50,000 a year in grant money raised by his organization goes to the for-profit Myriad "to help pay for the critically necessary tests" that his laboratory is blocked from developing.
What makes patents that limit access to testing even more questionable, Ledbetter says, is the fact that research conducted on the BRCA genes at the University of Utah was federally funded.
As the exclusive provider of the test in the United States, Myriad can decide the price of its test and which insurance companies to contract with, said Sandra Park, staff attorney with the ACLU Women's Rights Project.
Marsh said about 90 percent of Myriad's BRCA testing is "covered by some form of insurance." The average reimbursement is approximately 90 percent of test cost, he said.
Myriad offers free testing to uninsured patients who meet specific medical and financial criteria. The financial criteria are based on federal poverty guidelines, which indicate that a single person must earn $16,245 or less a year, while a family of four can earn no more than $33,075 a year.
"A substantial number of tests are run for free by Myriad under this program," Marsh said.
As the lawsuit makes its way through the courts, Girard is urging everyone to speak up about the gene patenting issue.
"A lot of other genes are patented, which will affect many other people," she said. "It's time for everyone to make their voice heard because this can impact them in the very near future."
Susan Elan covered politics at daily newspapers in the New York metropolitan area for more than a decade. She has also worked as a reporter for an English-language radio station in Paris.
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