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Public or Private?

Myriad CEO Peter Meldrum wrote into the New York Times in a June 20 letter, to highlight that while the Supreme Court invalidated the company's patent claims of isolated gene sequences, the court upheld several claims on synthetic DNA. In addition, he underscores the importance of diagnostic method patents.

Meldrum's letter was in response to the Woodrow Wilson International Center for Scholars' Eleonore Pauwels' June 18 op-ed in the Times in which she discusses the importance of sharing data from genetic testing in public databases to advance knowledge in the field and avoid allowing one company to dominate a testing market.

Since launching BRACAnalysis in the mid-1990s, Myriad has been the only company conducting commercial BRCA testing in the US. Even with the invalidation of several patent claims on isolated gene sequences, Myriad's major advantage over competitors now launching BRCA tests is its large proprietary database containing information on the around one million patients who have been tested on BRACAnalysis. The information in this database has helped Myriad determine the prognostic significance of many rare BRCA variants.

"There are significant public health consequences when any one company gets to wall off such important human biological data from its competitors and, ultimately, from the public," writes Pauwels, noting that an unintended consequence of the Supreme Court's decision on gene patents may be that biotech companies rely more on trade secrets. As a remedy, Pauwels recommends that the US Food and Drug Administration mandate public disclosure of certain data as a condition of granting market approval to genetic tests, and urged researchers "to get genetic information out into the public domain before any one company can call it a secret."

Meldrum, however, in his letter raised questions about the extent to which patient privacy might be protected under public data-sharing efforts.

"We agree with Ms. Pauwels that any genetic database used for clinical purposes should be regulated. We believe that medical decisions based on the interpretation of genetic data are crucial to the well-being of patients, and we know of numerous examples in which the clinical use of unregulated public databases has jeopardized patient safety or privacy," Meldrum writes. "Patients alone should ultimately have the right to decide whether their personal genetic data is deposited into public or government databases. At Myriad, our policies emphasize patient privacy and safety through our regulated laboratory process."

In a recent report, PGx Reporter covered public data-sharing efforts around BRCA testing and efforts to ensure privacy in such a project.