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

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

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

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

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

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’  

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

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

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...]

Emerging Tests

Serology Testing Critical to COVID-19 Survival & Post-Crisis Transition

There are two kinds of people who have SARS-CoV-2 antibodies in their systems: Those who are currently infected with COVID-19 (both symptomatic and asymptomatic), and those who were infected but have … [Read more...]

Point of Care

Are Rapid Immunodiagnostic Tests for COVID-19 Ready for Prime Time?

The success of treatment, quarantine and, ultimately, return to normalcy, all hinge on the development and dissemination of tests capable of not just accurate but rapid detection of COVID-19 … [Read more...]