Case of the Month

Feds Launch First COVID-19 Testing Fraud Prosecution

Stop me if you’ve heard this one before. The DOJ has charged a publicly traded Silicon Valley med tech firm and its CEO with touting a sham finger stick blood test to defraud payors and rip off … [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...]

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...]

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...]

LDTs

VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies

In standing aside and allowing test makers to validate and perform COVID-19 laboratory developed tests (LDTs) and not wait for Emergency Use Authorization (EUA), the FDA has actually acknowledged what … [Read more...]

Emerging Tests

How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed

The criticism leveled at the Food and Drug Administration (FDA) over the lack of diagnostic tests for COVID-19 in the U.S. belies the unprecedented speed with which new coronavirus tests are reaching … [Read more...]

FDA Watch

SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals

Key new U.S. Food and Drug Administration product approvals announced from mid-February 2020 through March 20, 2020 include emergency use authorization (EUA) for eight different commercial tests for … [Read more...]

FDA Watch

FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices

On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA … [Read more...]


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