Bloomberg reports the US Centers for Medicare & Medicaid Services sent Orig3n a letter saying it has not corrected lab issues uncovered in an earlier inspection.
The FDA has also granted emergency use authorization for PCR-based tests for SARS-CoV-2 developed by Orig3n, Specialty Diagnostic Laboratories (SDI), and the University of North Carolina (UNC) Medical Center.
Interleukin said in July that it would liquidate its assets after laying off 63 percent of its workforce and suspending sales of its controversial genetic test.
The American Dental Association wants insurers and test manufacturers to show genetic testing is scientifically valid before they're used to determine coverage eligibility.
The announcement comes three weeks after Interleukin said it was laying off 63 percent of its workforce and suspending sales of a controversial genetic test.
Geneticists and periodontists point to financial conflicts, the lack of genetics knowhow, and regulatory gaps for the availability of a test they say should have never come to market.
The New York Times reports that experts say President Joe Biden's goal of vaccinating 1 million people a day in the US in the next 100 days is too low a bar.