Probe Finds Orig3n Covid Test Put Nursing-Home Patients at Risk

(Bloomberg) -- Poor laboratory practices at a Boston company that performed Covid-19 tests for dozens of nursing homes in Massachusetts put patients at risk of harm, state public-health officials said.

On Friday, Bloomberg News reported that the company, Orig3n Inc., was responsible for more than 300 false-positive results at nursing homes across the state, spurring panic at facilities already hard-hit by the pandemic and costing some tens of thousands of dollars.

Orig3n, a consumer DNA-testing company that pivoted to coronavirus screening, has faced scrutiny for laboratory issues in the past. Still, Massachusetts officials had recommended the company to long-term care facilities seeking to comply with mandatory surveillance-testing requirements.

On Monday, the Massachusetts Department of Public Health said it had found that at least 383 coronavirus tests by Orig3n were erroneously positive. Additionally, state officials said Orig3n didn’t use controls in processing its tests, a critical step that can signal the presence of false results, and didn’t comply with requirements including documenting its sanitizing of equipment. The investigation also found shortcomings in the lab director’s management.

Massachusetts issued a statement of deficiency to Orig3n on Friday outlining ways in which it had failed to meet the criteria of the lab’s certification by the Centers for Medicare & Medicaid Services. Orig3n must respond to the state by September 14 with evidence it has addressed all of the issues in question. If action isn’t taken, the company could face sanctions by CMS.

“We’re currently working with the state of Massachusetts to finalize steps that will enable us to resume testing in our Boston lab,” Orig3n chief executive Robin Smith told Bloomberg in an emailed statement.

Orig3n received emergency authorization for its Covid-19 test in April from the Food and Drug Administration. The company was asked by the state to halt testing on August 8, though it continues to process Covid-19 tests for customers in other states at an outside laboratory.

The company told Bloomberg last week that it has processed “tens of thousands of Covid-19 tests over the past 90 days” for clients that include schools, nursing homes and employers. The company had contracts with about 60 nursing homes in Massachusetts, and at least 11 of them reported false positives.

Orig3n was one among many companies that abruptly pivoted to Covid-19 after a shortage in testing plagued the U.S. pandemic response. The company was previously best-known for DNA tests derided by some experts as more rooted in entertainment than science, including a test intended to reveal whether a person might be more likely to possess “unique superhero traits.”

CMS had previously investigated the company after a 2018 incident in which an investigation into home genetic tests by NBC Chicago found the company mistakenly processed a dog’s DNA, failing to recognize it wasn’t human when other testing companies did. A year ago Bloomberg Businessweek reported allegations from 17 former employees claiming lab issues at Orig3n had persisted after the investigation, including inaccurate tests, sample contamination, sloppy lab practices and tampering with results. At the time, the company said that the former employees were disgruntled and their accounts were “grossly inaccurate.”

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