Boston Lab Facing Penalties After COVID-19 Testing Errors

Orig3n, Inc., risks losing its lab certification after returning close to 400 false positive test results, prompting a state investigation in August.

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When she first spotted ads for a child DNA test marketed by the Boston company Orig3n, Katie Stoll wanted to learn more.

Stoll, executive director of the Genetic Support Foundation, a nonprofit that works to increase access to genetic counseling, said she was concerned about the ethics of genetic testing for kids.

She decided to buy a test and find out more. But instead of sending a human specimen, Stoll said she swabbed the inside cheek of her dog, Ginger.

The lab sent back a 35-page report, detailing Ginger's intelligence, fitness, and health. But it failed to note Ginger wasn't human.

Stoll repeated the test, this time running a swab under tap water. Again, a full genetics report came back.

"I was really surprised about that result," Stoll said, "and also more troubled than the first one, because it was actually signed out by the lab director."

Stoll, who filed a complaint regarding the lab with state and federal officials at the time, said she was bewildered to see the same company in the news recently – this time for errors in coronavirus testing.

The Massachusetts Department of Public Health opened an investigation in early August after it became aware of an unusually high positive rate of COVID-19 tests reported by Orig3n.

Retests found at least 383 false positives that were actually negative.

That lab now may be subject to sanctions from the federal government, including financial penalties and the possibility that its federal certification to operate a clinical laboratory will be revoked, according to records obtained this week by the NBC10 Boston Investigators.

After her own interaction with the lab two years ago, Stoll said she has questions about its testing procedures. NBC10 Boston couldn't independently verify her account of sending the lab non-human DNA, but her story was consistent with the results from a similar test by our station in Chicago.

Journalists there mailed out samples from a dog named Bailey to genetic testing companies around the country. They found all but one – Orig3n – detected the material wasn't suitable for testing.

Back then, Stoll asked the Massachusetts Department of Public Health and federal authorities to look into the lab. She says it's unclear whether her September 2018 complaint got any traction.

DPH did not respond to a request for comment Thursday on what became of Stoll's complaint. Documents received by NBC10 Boston from the state through a request made under the state's public records law show state surveyors visited the lab in response to a complaint in late 2019, though it's unclear what sparked their visit.

"I don't know how much, if any, investigation was really done regarding the concerns that I raised," Stoll said. "And I think that's really problematic, at this time when we need more trust in science and these lab results more than ever."

After investigating the false positive COVID-19 test results, the state notified Orig3n in late August it found "three significant certification deficiencies that put patients at immediate risk of harm," including failure of the lab's director to provide overall management and a failure to document the daily sanitizing of equipment used for coronavirus testing.

The lab tested specimens from Massachusetts and at least three other states after receiving an emergency authorization this spring from the U.S. Food and Drug Administration.

Of the nearly 400 false positive test results, 19 were sent to the Pines Edge skilled nursing center in Needham. In a statement, the facility's CEO said the episode caused "tremendous fear and anxiety among employees, residents and family members."

Responding to questions from NBC10 Boston, Orig3n's CEO said that human error caused the tests to become contaminated, and that the process has since been modified.

"We understand the critical importance of speed and precision in COVID-19 testing and we're committed to providing accurate, timely results for our clients," he said.

We also asked the business about its genetic testing. It didn't directly address our question, but previously told NBC Chicago that it made changes to detect what it called "nefarious samples." All testing at the Boston laboratory is now suspended.

Officials from the federal Centers for Medicare & Medicaid Services are now weighing penalties against the lab. In an Oct. 2 letter to Orig3n's lab director, CMS wrote that the lab's proposed corrective actions weren't sufficient, and that it risks losing its clinical lab certification, effective Dec. 2.

CMS suspended that certificate on Monday.

About 60 nursing homes in Massachusetts have been clients of the lab, state authorities said.

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