The American Civil Liberties Union on Thursday filed a complaint with the federal government accusing genetic testing company Myriad Genetics Inc of refusing to provide four patients with personal genetic information they requested, though the company has now provided it.
The complaint was filed with the U.S. Department of Health and Human Services’ Office of Civil Rights, according to the ACLU. The organization said the complaint was the first of its kind.
The complaint says Myriad had violated the federal Health Insurance Portability and Accountability Act, which guarantees patients access to their medical records, by providing test reports that included only findings Myriad deemed clinically actionable.
Sandra Park, an attorney with the ACLU, said the organization was pushing ahead with the complaint even though Myriad gave the patients the information late on Wednesday. Park said the group wants to seek a determination that patients have a right to all their genetic information.
Spokesman Ron Rogers told Reuters the company’s decision to provide the information was not done to head off the ACLU complaint and that the company plans to provide the same kind of information to any patient who asks in the future.
“As far as we’re concerned, the matter is resolved,” Rogers said. “We think the ACLU’s claim is without merit.”
HHS’s Office of Civil Rights will now decide whether to launch an investigation into Myriad. The agency can order companies to take action to comply with HIPAA and impose monetary penalties if they do not.
Myriad’s control of genetic information has attracted criticism before. The company received patents on two genes, called BCRA1 and BCRA2, that it tests for variants linked to breast cancer and other types of cancers. That gave it a monopoly over the tests until June 2013, when the Supreme Court ruled that naturally occurring genes cannot be patented.
The patients’ doctors ordered genetic testing from Myriad to look for BCRA1 and BCRA2 variants. Three of the patients have been diagnosed with cancer. The fourth is the cousin of one of the others.
The four asked Myriad in January to turn over all the genetic information it collected, including genetic variants it deemed benign, so they could share them with the scientific community, according to the complaint.
Myriad responded in March that it was not required to do so.
The complaint cites guidance released by HHS in January stating that HIPAA gives patients access to “underlying information” from genetic tests.
(Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and David Gregorio)