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Maryland House Legislators Introduce Bill on DTC Genetic Testing

NEW YORK (GenomeWeb) – A bill introduced last week in the Maryland General Assembly would allow labs to provide direct-to-consumer genetic testing in the state with CLIA certification, but would not mandate clearance or approval of tests from the US Food and Drug Administration.

Bill 1392, introduced by Republican members of the House of Delegates Neil Parrott and Richard Metzgar, defines direct-to-consumer (DTC) testing as a genetic test that can be ordered by the consumer without having to go through a healthcare professional.

The bill would require labs selling genetic testing services DTC to have CLIA certification. Labs also must advise customers to talk with their doctors or a genetic counselor about test results; inform them of policies on the security and confidentiality of protected health data; and disclose how genetic information may be used in research. If the testing firm wants to share a customer's name or other identifying information with a third party, the customer must provide written consent, the bill states.

Moreover, the bill would require labs to warn consumers that test results may be used to deny, limit, or charge a higher rate for long-term care insurance coverage, disability insurance coverage, or life insurance coverage, which are not covered by the Genetic Information Nondiscrimination Act of 2008. The labs would have to tell customers that failing to disclose genetic testing results when applying for these types of insurance policies could lead to cancellation of the policy or denial of coverage.

Maryland law currently only allows doctors or other authorized persons to order lab tests and generally restricts consumers' ability to directly order testing. There are a few exceptions. For example, consumers can directly purchase tests approved by the FDA for home use.

But in recent years there have been legislative efforts in the state to expand consumers' access to DTC genetic testing. In 2014, Maryland legislators introduced two bills — one in the House that would have expanded labs' ability to offer DTC testing when they met certain conditions and another in the Senate to allow labs to advertise to and solicit business from non-healthcare entities.

Maryland's Department of Health and Mental Hygiene, under former Secretary Joshua Sharfstein, thought that the bills should be advanced with amendments that ensured consumer privacy, required labs to disclose potential psychological risks, and restricted labs from making any clinical validity claims on tests not approved by the FDA.

Sharfstein, currently at the Johns Hopkins Bloomberg School of Public Health, has written about the need to bring all lab tests under FDA oversight. The FDA, meanwhile, has said it plans to finalize regulatory guidance on lab tests this year, and has specifically indcated that DTC genetic tests will require the agency's review. House Bill 1392, which was introduced in the Committee of Health and Government Operations on Feb. 12, does not include the Maryland health department's earlier recommendations in this regard.

When DTC genetic testing firms, such as 23andMe, first launched a decade ago, Maryland, along with New York and California, took a hard stance against such services. The DTC market, genetic testing technologies, and the federal regulatory environment have evolved since then.

23andMe, which had to stop marketing health-related DTC tests throughout the country in 2013 due to regulatory difficulties with the FDA, received de novo 510(k) clearance from the agency last year for its Bloom Syndrome test. Along with that decision, the agency classified carrier screening tests as Class II devices and exempted such tests from having to garner premarket review if labs met certain conditions. In particular, the agency said results of these carrier screening tests had to be communicated in a way that consumers could understand, similar to other over-the-counter or home-use tests for medical purposes. 

In December, 23andMe issued a release stating that the FDA's designation of its Personal Genome Services as an over-the-counter device lifts state restrictions, allowing the firm to provide more than 60 health, ancestry, wellness, and personal trait genetic testing reports in Maryland and New York.

“We are thrilled that our customers in both New York and Maryland will now be able to explore their own DNA without restrictions,” said 23andMe CEO Anne Wojcicki at the time. “Customers in both states can now take full advantage of our newly launched and completely redesigned experience, which includes reports that meet FDA standards.”

The company's terms of service informs customers about GINA's limitations, tells them not to assume that the results "will be welcome or positive," and states that they may need to consult a doctor or a genetic counselor to make sense of the results, particularly as research advances. The firm also details its research participation and consent policies to consumers.