Home Genetic Testing Faces Legal Hurdle in Maryland


COLLEGE PARK – With the cost of DNA sequencing dropping rapidly, hundreds of thousands of Americans are taking in-home genetic tests to learn their risk of developing certain diseases. But Maryland residents have largely missed out on the opportunity.

Companies like 23andMe, Map My Gene, GenePlanet, and easyDNA offer genetic tests for as little at $99, making it possible for people across the country to learn more about their own genes.

“Understanding what you’re predispositioned to, it’s not destiny, but it can provide information that helps you prioritize your health care,” said Catherine Afarian, a spokeswoman for 3andMe.

These at-home tests—known as “direct to consumer” genetic tests—require consumers to spit in a cup and mail the sample back to the company’s lab. In return, consumers receive a detailed genetic report about their propensity for certain cancers, cardiovascular conditions, blood and immune system disorders, even genetic markers for certain mental and behavioral health disorders.

Maryland residents are being left behind in the genetic boom, thanks to a state statute that effectively bars at-home genetic sequencing tests.

Under current Maryland law, medical tests of any kind must be ordered by a medical professional or as part of a court order. Another state law bars personal genome testing companies from advertising their services within the state.

The only other state to include effectively ban at-home genetic tests is New York, which does not allow saliva to be sent through the mail.

The ban in Maryland could end soon.

The state’s Department of Health and Mental Hygiene is examining research on direct to consumer genetic tests and plans to release a paper in the next month, said Laura Herrera, deputy secretary of public health services. The department will seek public input on whether legislation should be introduced in 2014 to allow for at-home genetic tests in Maryland.

Professional medical organizations and insurance companies argue that at-home genetic tests should only be conducted with the guidance of medical professionals.

“Because the results of genetic tests are seldom straightforward and the health conditions they address are complex, they should be done with the guidance of a physician, genetic counselor, or other genetics specialist,” Ardis D. Hoven, president of the American Medical Association, said in a statement.

Genetic testing companies like 23andMe, Map My Gene, GenePlanet, and easyDNA provide disclaimers that tell customers that simply having a genetic marker for a disease does not guarantee they will develop it.

The companies do not offer face-to-face genetic counseling that helps patients interpret family history and make informed choices about their health care if faced with a genetic condition or risk of developing one. Some companies, like 23andMe and Map My Gene, offer to connect customers with qualified counsellors but do not offer that service directly.

This, Hoven said, could lead patients to spend money on tests needlessly or misinterpret the results of their tests, which could lead to unhealthy or unneeded lifestyle changes.

Most insurance companies—like Cigna, Humana, and Kaiser Permanente—only cover genetic testing when ordered by a physician and when a number of other conditions are met, arguing that at-home genetic testing is still experimental and does not offer any form of support for the customer after providing their genetic background.

While critics of at-home genetic testing argue that a wealth of genetic knowledge can lead to various stressors or unwarranted calls to physicians for those who participate, companies like 23andMe see at-home testing as a valuable tool for a person’s health.

Founded in 2006, 23andMe made its first personal genome kits available in 2007 for $999. Home testing kits from 23andMe now cost $99, thanks to a round of funding that gave the company an extra $50 million.

23andMe was established with two main purposes: to provide anyone who wanted it access to their own genetic data and to make a large pool of data available to genetics researchers. They provide customers with a detailed genetic history and use graphics to help users understand their genome.

The company hopes that the collaboration between customers and scientists will lead to further genetic discoveries.

“Our mission is to tell you everything that science can right now,” Afarian said.

By using the latest genetic research to inform their testing—which is done in a federally-certified lab—as well as collaborative work with genetic researchers, 23andMe attempts to defy critics of at-home genetic testing by offering state-of-the-art results with easy-to-understand explanations.

“We believe that genetics is such an exciting area for health care, it’s just going to become a bigger and bigger piece,” Afarian said. “It’s a matter of time before the current restrictions will come under pressure from residents who want to take control of their own healthcare.”

Home Genetic Testing Faces Legal Hurdle in Maryland

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