As Consumer DNA Testing Grows, Two States Resist
Earlier this month, more than 55,000 football fans were expected to walk through the gates of M&T Bank Stadium to watch a Baltimore Ravens game and receive a giveaway. They wouldn’t be getting a T-shirt or beer koozie, though. Instead, fans were promised a free DNA test from Boston-based startup Orig3n.
Patrons would have been offered a free test for four genetic variants related to health and fitness. But the event was postponed after state officials raised questions about whether the company could promote its DNA tests in Maryland.
Orig3n is one of a slew of new companies that promise to provide personalized health information on your skin, athletic ability, diet, intelligence, and other traits based on your genetic makeup. Known as direct-to-consumer genetic tests, they are available at the click of a mouse for $200 or less. You spit into a vial or swab your cheek and send your saliva through the mail, no prescription sign-off from your physician required. But two states—Maryland and New York—are holding out against these tests.
Maryland state law allows only doctors or other authorized health-care practitioners to order lab tests, with a few exceptions. Consumers can directly purchase tests that have been approved by the U.S. Food and Drug Administration as “over-the-counter” devices. Orig3n has not received that designation.
Maryland also doesn’t allow lab tests to be directly marketed to consumers, only to physicians, hospitals, and laboratories.
In a statement, Orig3n said the event will be rescheduled for later in the season while the company is “working to address questions from officials from the state of Maryland.” It declined to answer specific questions about the event.
Kristin Carter, an attorney at Baker Donelson in Baltimore, who advises clinical laboratories on legal issues involving direct-to-consumer lab testing, says she was surprised Orig3n would hold such an event in Maryland given these restrictions.
Interested patrons would have been able to swab their cheeks and then drop off their DNA samples in bins around the stadium. They would sign up for access to an Orig3n website to view their results later on.
In New York, state law only allows a laboratory to offer direct-to-consumer testing without a prescription from a licensed health-care professional if the test has been approved or cleared by the FDA, according to the New York State Department of Health.
Earlier this year, the FDA gave 23andMe the green light to directly sell consumers DNA tests that estimate their risk for 10 different diseases, including late-onset Alzheimer’s disease and Parkinson’s. They are the first direct-to-consumer genetic tests to get FDA approval. As a result, 23andMe can sell its tests in both Maryland and New York.
Maryland and New York’s laws are meant to protect consumers from companies making dubious claims about DNA tests and also make sure people receive proper advice and counseling from their doctors about their medical results. But they won’t stop all tests from being sold to consumers.
The FDA only regulates medical tests intended to provide a diagnosis or guide a patient’s treatment. The agency doesn’t need to approve ancestry and genealogy tests. It also doesn’t regulate DNA tests that are for entertainment—tests like Wine Explorer by Vinome, which says it can tell your preference in wine based on your genetics, or SlumberType by Exploragen, which claims to analyze how your DNA influences your sleep behavior.
Michelle Meyer, associate director of the Center for Translational Bioethics & Health Care Policy at Geisinger Health System, says she is generally suspicious about whether such tests provide any kind of helpful information.
“I would tend to approach these things as a form of entertainment and not take them seriously,” she says. “Most traits are caused by more than one gene. The test you’re taking is probably looking at one. It’s not going to give you a complete picture.”
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Other direct-to-consumer genetic tests—which aren’t meant to diagnose a disease but measure certain health or physical traits—may be more confusing to consumers, so state regulators are stepping in.
For instance, on the website of Helix, an “app” store for direct-to-consumer genetic tests, you can see that some tests can’t be ordered in certain states.
Orig3n offers a suite of six DNA tests, including ones for behavior, skin characteristics, fitness, nutrition, child development, and a six-gene profile called a Superhero DNA Test that is supposed to reveal whether you have above-average intelligence or superior strength.
The FDA hasn’t said whether it will regulate these types of health-related tests.
On its website, Orig3n says its DNA tests “are not diagnostic tests and cannot predict your future health.” Instead, its products are “for informational purposes only.” But states like Maryland and New York still might have a say in whether the company can offer them to customers there.
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September 11-14, 2018
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