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
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...]
FDA Watch
Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time
April 20, 2020
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
April 19, 2020
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
April 19, 2020
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?
April 19, 2020
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...]
