LDTs

HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization

One of the unforeseen results of the coronavirus public health emergency has been to bring the perennial controversy over U.S. Food and Drug Administration (FDA) premarket regulation of laboratory … [Read more...]

LDTs

FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests

Bloated and unsubstantiated marketing claims about the capabilities of unproven serologic SARS-CoV-2 antibody tests have been a problem almost since the public health emergency began. After playing … [Read more...]

FDA Watch

First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests

After initially allowing producers of serologic SARS-CoV-2 antibodies tests free access to the market, the US Food and Drug Administration (FDA) is now cracking down on unproven and inaccurate … [Read more...]

LDTs

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...]

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...]

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...]

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...]


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