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CMS Letter to Orig3n

Orig3n, the consumer genetic testing company that switched to COVID-19 testing earlier this year, has received a letter from the US Centers for Medicare & Medicaid Services saying the company has not corrected lab issues uncovered in an earlier inspection, according to Bloomberg.

Last month, WBUR reported that Massachusetts suspended COVID-19 testing at the company after noticing a high number of false positives among the company's results. At the time, Bloomberg reported that state health officials had found problems with the company's use of controls and with its documentation of equipment sanitization. 

Other issues have previously been raised regarding Orig3n's DNA testing. For instance, in 2018, NBC Chicago sent samples to the company for testing that were from a dog, a problem that was not caught by the firm's test.

Bloomberg now reports CMS in its letter to Orig3n earlier this month said it is considering sanctions against the company, such as the suspension or revocation of its license and fines, if it does not address the issues that the agency says posed an "immediate jeopardy to patient health and safety."

"During the past couple of months, we've made significant efforts to evaluate, improve, and validate our processes both internally and with assistance from external experts and third-party laboratories," Robin Smith, the Orig3n CEO, says in a statement, according to Bloomberg. "We're committed to addressing any questions that CMS might have."