Daily Update

Tests with EUA

July 3, 2020

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test) Date Manufacturer(s) Test Receiving EUA July … [Read more...]

Diagnostic Breakthroughs

Researchers Develop Scalable Antibody Test to Detect COVID-19 Immunity

June 23, 2020

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...]

LDTs

FDA Sets the Bar on Specimen Pooling & Asymptomatic Screening for SARS-CoV-2 Test Development

June 22, 2020

On June 16, the US Food and Drug Administration (FDA) issued new guidance addressing two key issues related to SARS-CoV-2 testing: validation processes for test pooling of samples for test development … [Read more...]

FDA Watch

After Initial Resistance, Agency Warms to Home COVID-19 Testing

May 27, 2020

Back in March, the US Food and Drug Administration (FDA) stated that the newly liberalized clearance scheme it was deploying to expedite the COVID-19 diagnostic testing pipeline did not apply to … [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...]

Test Utilization

COVID-19 Test Shortage Is Real & Likely to Last through 2020

May 26, 2020

Sadly, the question of whether there is enough COVID-19 testing in the U.S. to meet demand has become a political football. Here is a look at the findings of one group that set out to answer this … [Read more...]

Emerging Tests

SARS-CoV-2 Antigen Testing Is Here but Is It Really a ‘Game Changer’  

May 25, 2020

First came the molecular and then the serological assays. And now a third kind of coronavirus testing methodology has made its official US debut: antigen tests. Some have hailed this development as a … [Read more...]

Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing

April 22, 2020

On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]

The COVID-19 Crisis

Easy & Rapid Testing Remains Unavailable to Most Physicians

April 20, 2020

New laboratory tests to detect COVID-19 are clearing the Food and Drug Administration and reaching the US market faster and in volumes greater than anybody would have ever dared to expect. But so far … [Read more...]


(-00000g2)