Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
On Jan. 27, BioFire Defense's COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more than...
An Illinois-based COVID-19 testing company and its laboratory is facing lawsuits from two different states as well as investigations from several state and federal authorities after patient and employee complaints brought to light a number of problems. The Center...
The National Institute for Occupational Safety and Health (NIOSH) provided more than $5 million in extramural funding during fiscal year (FY) 2021 to 38 projects that address challenges related to the coronavirus disease 2019 (COVID-19) pandemic. This amount...
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
Here’s a look at the key takeaways from the Dec. 30 OIG report on Medicare Part B spending on lab testing.
