Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [Read more...]
The Business of Testing
HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19
November 24, 2020
LDTs
FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19
November 2, 2020
On Oct. 9, the U.S. Food and Drug Administration (FDA) dropped a bombshell by announcing that it would no longer review applications for Emergency Use Authorization (EUA) submitted by test makers for … [Read more...]
LDTs
HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization
August 29, 2020
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
August 7, 2020
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
June 25, 2020
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
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...]
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...]
