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Myriad: Patients seek right to access personal genetic information

23 May 2016
Appeared in BioNews 852

Myriad Genetics has been hit by a complaint filed by the American Civil Liberties Union (ACLU) on behalf of four patients who are seeking a right of access to all their genetic information held by the company relating to genetic testing for cancer.

Even though Myriad has now provided the information that was sought by the complainants, the ACLU has said that it intends on pursuing the complaint to establish the rights of patients to all their genetic information.

Sandra Park, a lawyer with the ACLU, told GenomeWeb: 'We're continuing to move forward with the complaint in order to … address the larger issue of whether the lab will provide this data to every patient who seeks it.'

Following genetic testing for cancer risk, the company provided the patients with information it deemed significant, but withheld data that was benign or it thought was clinically insignificant.

The patients requested access to all the genetic variants identified during testing so that they would be able to monitor their own and their families' cancer risk as genetic knowledge advances, as well as examining Myriad's interpretation of the variants identified in their genes.

They also wanted the information so that they could share it with the research community. GenomeWeb reports that Myriad stopped contributing to public genetic databases some years ago, although the company contends that it does extensively publish its data.

Runi Limary, one of the complainants who received a genetic test from Myriad in 2007, said: 'I care deeply about patients being able to access their own genetic data to make the best decisions for themselves.

'A laboratory shouldn't be able to stop me from accessing my own data to share with researchers who could be reaching a deeper understanding of these genes.'

The complaint, which the ACLU says is the first of its kind, has been filed with the US Department of Health and Human Services' Office of Civil Rights (OCR). It will now decide whether to launch an investigation, after which it can compel the company to act in accordance with privacy rules and could also result in the imposition of fines.

Just hours before the complainants went public, Myriad decided to comply with the request after receiving advice from the OCR about its obligations under US privacy rules, GenomeWeb reports.

'As far as we're concerned, the matter is resolved', Ron Rogers, Myriad's communications executive said. 'We think the ACLU's claim is without merit.' He added that the company plans to do the same for any patient who asks for it in the future. However, Park said that although Myriad provided the information voluntarily, it had not confirmed its obligation to do so.

The patients involved in the lawsuit all underwent genetic testing for BRCA1 and BRCA2 genes using Myriad's BRACAnalysis test. Myriad held patents over the genes until they were invalidated by the US Supreme Court in 2003 (reported in BioNews 709), in an action that also involved the ACLU.

In its report, GenomeWeb mentions speculation among commentators that since Myriad's BRCA gene patents were invalidated and competition opened up in the genetic testing market, gene testing companies would instead seek to maintain competitive advantages through the use of trade secrets.

After a prominent gene-testing firm declined to give patients their complete data, ACLU filed a legal complaint
Science (AAAS) |  19 May 2016
Health Information Privacy Complaint
US Deparment of Health and Human Sciences Office for Civil Rights (complaint) |  19 May 2016
Myriad hit with complaint over access to genetic information
Reuters |  19 May 2016
Our genes, our data: Patients' right to access their own genetic information
American Civil Liberties Union |  18 May 2016
Patients File HIPAA Complaint Against Myriad Genetics for Withholding Variant Data
genomeweb |  19 May 2016
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