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The state has suspended Boston-based DNA testing firm Orig3n from performing coronavirus tests after it allegedly provided 383 false positives.
The DNA testing lab received emergency authorization from the FDA in April to perform COVID-19 testing. Massachusetts Department of Public Health spokeswoman Ann Scales said the department began looking into Orig3n in early August because the company was reporting an "unusually high positivity rate."
Orig3n has not performed any COVID-19 testing on Massachusetts specimens since Aug. 8, per the state's request.
At the end of last month, DPH shared its findings with Orig3n and named three "significant certification deficiencies" that put patients at risk. DPH found that the lab director failed to provide management, the lab did not include a control material in the extraction phase of testing, and the lab did not adhere to requirements like documenting sanitization of its equipment.
Orig3n is now expected to respond with a plan of correction by Sept. 14, according to DPH, or face sanctions.
An Orig3n spokesman told Gannett New England, which first reported the story last week, that the false positives were due to “human error" at the beginning of the laboratory testing process that caused some tests to become contaminated.
The spokesperson, Tony Plohoros, said the lab is working with state health officials to correct problems at the facility.
About 60 nursing homes have been clients of the lab, state authorities said. Earlier this year, Orig3n donated a thousand coronavirus tests to people experiencing homelessness in Boston.
With additional reporting from The Associated Press
This article was originally published on September 07, 2020.
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