ACLU skirmishes with local genetic testing company

ACLU skirmishes with local genetic testing company

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SALT LAKE CITY — The American Civil Liberties Union is pressing ahead with a complaint against a Salt Lake City-based molecular diagnostics company on behalf of four patients who say they were refused access to their complete testing results.

Sandra Park, a lawyer with the ACLU, said the organization filed the complaint with the U.S. Department of Health and Human Services on May 19, even though Myriad Genetics agreed to release the data to the patients.

In the complaint, patients say the company declined to release the full results of tests on two genes with links to breast cancer in a timely manner.

Some variants of genes are associated with high risk of cancer; others are considered harmless and are not included in the standard test results.

Patients in the complaint said they were denied access to those results, which they wanted for personal use or to give to other researchers.

Park said she is pressing forward with the complaint despite the fact that Myriad Genetics agreed to release the information to the patients because the company has not been clear about whether it considers it a legal obligation.

She argued that no patient should be in a position “where the company has more of their genetic information than they do" under the Health Insurance Portability and Accountability Act, also known as HIPAA.

“On the one hand, they’ve said they gave the information to our clients, but they never clearly said they would give it to all patients that would ask for it,” Park said.

Myriad Genetics spokesman Ron Rogers said the company wanted to comply with patients' requests and needed time to clarify the federal government’s stance.

In the past, Myriad Genetics has given out benign variant data to patients, but the company paused this time because patients cited a new federal guidance the company had not been aware of, Rogers said.

Myriad Genetics representatives met face to face with federal officials in Washington, D.C., in April to discuss the issue, he said. After that meeting, Myriad Genetics released the information to the patients and agreed the company is legally obligated to provide the testing results to patients, Rogers said.

"At this time we've complied fully with their request,” he said. “There's nothing more for us to provide at this point. … There's not going to be any issue going forward. Patients who request this information are going to be able to access this information within the 30-day window."

Park said she expects to see such cases become increasingly common as genetic technology becomes more advanced and available to the public.

"As more and more patients are going to be getting genetic testing, more and more of them will need to be educated about what that means in terms of access to their genetic information," she said.

Myriad Genetics has faced criticism from data-sharing advocates before.

In 2013, the company was the subject of a landmark Supreme Court ruling that human genes cannot be patented. Myriad Genetics, which discovered two genes known as BRCA1 and BRCA2 that are associated with a high risk of cancer, had been blocking other companies from offering tests on those genes.

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Daphne Chen

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