First came the molecular and then the serologic assays. And last month, the FDA granted emergency use authorization (EUA) for a COVID-19 assay based on a third kind of testing methodology: antigen … [Read more...]
Emerging Tests
FDA Pulls Back the Reins on Makers of Unproven Coronavirus Serology Assays
May 27, 2020
The U.S. Food and Drug Administration continues to struggle in its quest for a regulatory policy to unlock the potential of blood-based COVID-19 serology testing while reining in fraudulent marketing … [Read more...]
COVID-19 Serology Testing
Now Even the “Good” Tests Are Coming Under Fire
May 26, 2020
The inaccuracy of serology tests that detect antibodies to the SARS-CoV-2 virus has become an issue of mounting concern. Even though the lack of sensitivity and specificity of these tests is well … [Read more...]
FDA Watch
Dozens of New COVID-19 Tests Get Emergency Clearance in April
May 8, 2020
As of April 30, 69 COVID-19 assays have received Emergency Use Authorization (EUA) from the FDA, including seven serology tests, one saliva-based test and an at-home testing kit. What began as a … [Read more...]
Emerging Tests
The FDA’s High-Stakes, High-Risk COVID-19 Serology Test Regulatory Strategy
May 2, 2020
Serology testing capable of distinguishing whether SARS-CoV-2 antibodies in a person’s systems are due to a current or previous COVID-19 infection could play a pivotal role in the re-opening process … [Read more...]
FDA Watch
Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time
April 20, 2020
The US Food and Drug Administration (FDA) has taken a lot of heat for wasting precious time in responding to the COVID-19 emergency. While this criticism is fair, it is also true that the agency has … [Read more...]
Pandemic & Progress
First Saliva COVID-19 Test Secures FDA Approval
April 19, 2020
One of the toughest parts of COVID-19 laboratory testing is the sample collection process. A swab must be inserted into each nostril, one at a time, to the nasopharynx at the back of the nasal cavity, … [Read more...]
