enetic testing company Myriad Genetics, the defendant in a landmark Supreme Court case over gene patents, is back in the spotlight — this time, for withholding genetic data from patients.
Myriad held patents on the BRCA1 and BRCA2 genes until 2013, and tested more than 1 million patients for variations in those genes that might increase a person’s risk of breast, ovarian, prostate, and other cancers.
Though Myriad no longer holds the patents on those genes, it still holds patients’ data, and has been resistant to sharing it with researchers or public databases.
Now, a group of four patients allege that the company is also resisting sharing full test results with patients themselves.
The Health Insurance Portability and Accountability Act (HIPAA), mostly known for its protections on patients’ privacy, also includes provisions guaranteeing patients access to their health information. A complaint filed on Thursday by the American Civil Liberties Union claims that Myriad has violated HIPAA by refusing to provide the full genotype data that they generated from patients.
“I should have access to all the data that is generated from my body,” said Anne-Marie Ciccarella, one of the patients named in the complaint. Ciccarella wrote to Myriad in February to request her complete genomic information. Myriad refused, saying that genetic information is not included in HIPAA rules regarding patients’ access to their health information.
But the rules are pretty clear, said Sandra Park, a lawyer with the ACLU. Guidance issued by the Department of Health and Human Services in January says that an individual has the right to “not only the laboratory test reports but also the underlying information generated as part of the test, as well as other information concerning tests a laboratory runs on an individual.”
Ciccarella wants to contribute her data to a public archive of genetic data called ClinVar. “I am absolutely committed to this genetic data being shared,” she said.
Wednesday evening, Myriad reversed course and provided the ACLU’s four clients with additional information. For Ciccarella, that information included 15 variants on her BRCA1 and BRCA2 genes, far more than the 2 variants disclosed in her official test results. She said she will now take that information to specialists to help her interpret its significance.
This action shows “that Myriad does keep additional variant information on patients and that it can be provided to them,” the ACLU complaint says.
Myriad spokesman Ron Rogers said Myriad patients will receive their full genetic information upon request.
“Any patient who asks for this information will receive it within 30 days, which is what we’re required to do,” Rogers said. “And we’ll comply with that.”
ACLU spokesman Thomas Dresslar said the group wants an official decision supporting patients’ right to their genetic information.
“That would ensure that Myriad will turn over the full genomic record to all patients who request their records in the future,” he said.
Ciccarella agreed. “What was done for me should be done for every patient who wants access to their own genetic information.”