Scalable, accurate assays capable of not only COVID-19 detection but actual immunity to the virus will be critical for social distancing, virus surveillance and treatment. And now researchers at the … [Read more...]
Diagnostic Breakthroughs
Researchers Develop Scalable Antibody Test to Detect COVID-19 Immunity
June 23, 2020
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...]
Diagnostic Deals
How Curative & KorvaLabs Created a Successful COVID-19 Testing Lab in Less than a Month
May 8, 2020
Say what you will about the current state and availability of COVID-19 diagnostic testing, the energetic, imaginative and speedy response by certain segments of the lab industry has been nothing short … [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...]
