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Mayo will send 100K DNA samples to drug maker

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Mayo Clinic's Biobank is preparing to start sending the genetic code of 100,000 patients to a private drug maker as part of an "exchange."

The agreement, signed in June, is with Tarrytown, N.Y.-based Regeneron Pharmaceuticals. Mayo Clinic has promised to process 100,000 patient blood samples, prepare the DNA and ship them to Regeneron for sequencing, according to Dr. Keith Stewart. Stewart is the medical director for the Mayo Clinic Center for Individualized Medicine.

Regeneron is a 31-year-old drug maker that posted revenue of $1.93 billion for the second quarter of 2019. It produces a wide variety of drugs. It's currently in the news for working on an experimental treatment for Ebola. Like Mayo Clinic, the Geisinger Health System in Pennsylvania has a similar DNA-sharing agreement with Regeneron.

While some media reports have used this deal as an example of drug companies shelling out "hundreds of millions of dollars for access to patient information," Stewart said it's not a financial agreement.

"There's no exchange of money … It's a mischaracterization to say it is a sale," he said. "It's more of an exchange. We see it as a win-win."

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Stewart explained that Mayo Clinic doesn't have money to pay for the sequencing, so having Regeneron do it is a benefit. It costs $250 to $300 per sample for the sequencing process, he said.

Once Regeneron sequences the DNA sent by Mayo Clinic, it will use the data in the development of new drugs and possibly sell the anonymous data to other companies for their research. Also, Mayo will be returned the data from its patient samples to use in its own research.

Dr. James Cerhan, the principal investigator for the Mayo Clinic Biobank, explains that all of the patients who provided samples to the biobank consented for their DNA to be used for commercial purposes, though Regeneron was not directly named.

The 100,000 samples, many from Mayo Clinic employees, are about 10 years old, dating back to the biobank's creation in 2009, he said.

Cerhan said Mayo Clinic is in the planning stages for this project and expects to start shipping DNA to Regeneron in the first quarter of 2020. He estimated that it will take about a year and a half to process and ship the 100,000 samples.

The sample donors have not been directly notified about this agreement, though the deal was approved by the biobank's eight-member access committee. One member of that group represents the biobank's community committee. The access committee also includes a bioethicist. Cerhan is chairman of the committee.

The community committee mostly includes people not associated with Mayo Clinic, though some donors who are also employees might be members, said Stewart. All donors to the Mayo Clinic Biobank receive a twice-a-year newsletter detailing its projects.

In a "Wall Street Journal" article about the Mayo/Regeneron agreement, Arizona State University Professor Dr. Robert Cook-Deegan said patients should be notified about their DNA being given to a drugmaker that could use it for financial gain. He stressed that donating blood to a nonprofit hospital is very different than giving blood to private pharma company.

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While Regeneron and Mayo Clinic will have access to the DNA data, it will not be added to the donors' medical records. The consent forms specifically say no information will be added to patients' medical records.

"It is research data (the Regeneron sequencing) that is not conducted to clinically valid guidelines. The intent over time is, if there are findings that we feel are significant to a patient's health, that we may choose to (repeat them) in a clinical lab and that clinical lab information would be entered into the medical record," said Stewart.

Cerhan added that dropping complex genetic data into a patient's record could be confusing and upsetting.

"There are some real complications with that," he said. "Some people don't want to know anything. Others are very interested."

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