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Trying to simplify science

"Trying to simplify science" Continued...

Women who inherit a mutated BRCA gene have a 36 to 85 percent lifetime risk of developing breast cancer, and a 16 to 60 percent chance of developing ovarian cancer. For some women, learning they have a BRCA mutation and a family history of cancer is reason enough to ask a doctor to remove breasts or ovaries as a preventative measure, even if no tumor has been found in their body.

But to have their BRCA genes checked, women can use only one company, Myriad, which charges a hefty $3,340 for its test. Critics say Myriad’s patents prevent other companies from developing their own tests for the BRCA genes and perhaps lowering the cost.

Women who want a second opinion before deciding on a mastectomy can’t get one without Myriad’s permission, because the company controls a private database indicating which mutations carry a cancer risk.

Myriad had been sharing risk data with the National Institutes of Health until 2004, when it withdrew because, according to Myriad, other researchers were using the data inappropriately. Myriad claims it allows women to seek an independent second opinion through LabCorp. But in the end LabCorp’s test results are interpreted by Myriad.

One researcher from the University of California, San Francisco, has already decided to take matters into his own hands: Since Myriad won’t release its risk data, Robert Nussbaum launched a project to pay researchers and doctors to submit individual Myriad test results (there are millions of them) for a small payment. By compiling the test results, the project will attempt to replicate Myriad’s secret database. The “Sharing Clinical Reports Project” has catalogued hundreds of BRCA mutations since it began a year ago.

In deciding the case, the Supreme Court could try to take a balanced approach by striking down gene patents that apply to unaltered, isolated genes, and leaving untouched patents of genetic material that have been manipulated in certain ways.

The case, Association for Molecular Pathology v. Myriad Genetics, was originally filed in 2009 and has bounced around in lower courts, where federal judges have alternately struck down and upheld the BRCA patents. Since Myriad’s 20-year patents on the BRCA genes will expire within two years, some observers say the Supreme Court’s ruling—expected in June—will come too late to have much of an effect on the availability of BRCA testing.

Daniel James Devine
Daniel James Devine

Daniel is managing editor of WORLD Magazine and lives in Indiana. Follow Daniel on Twitter @DanJamDevine.


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