New Products

First SARS-CoV-2 Antigen Test Gets EUA Clearance from the FDA

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...]

FDA Watch

Agency Draws a New Line on SARS-CoV-2 Antibody Serology Tests

It took a while but the FDA has finally come to the realization that letting blood-based serology tests for detection of SARS-CoV-2 antibody tests into the U.S. market without requiring test makers to … [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...]

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...]

FDA Watch

Dozens of New COVID-19 Tests Get Emergency Clearance in April

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

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

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

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...]