SARS-CoV-2 serology antibody testing—reliably indicating whether persons with SARS-CoV-2 have COVID-19 or had COVID-19 and are thus presumably immune from getting it again—has the potential to provide … [Read more...]
Emerging Tests
The FDA’s High-Stakes, High-Risk COVID-19 Serology Test Regulatory Strategy
May 2, 2020
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...]
Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
April 22, 2020
On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]
The COVID-19 Crisis
Easy & Rapid Testing Remains Unavailable to Most Physicians
April 20, 2020
New laboratory tests to detect COVID-19 are clearing the Food and Drug Administration and reaching the US market faster and in volumes greater than anybody would have ever dared to expect. But so far … [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...]
Emerging Tests
Inside the FDA’s Four-Armed COVID-19 Test Response Strategy
April 7, 2020
What started as the traditional Emergency Use Authorization (EUA) response deployed by the FDA for previous infectious illness outbreaks has rapidly evolved into something altogether different and … [Read more...]
FDA Watch
The Month in Global New Diagnostic Test Approvals
April 7, 2020
In addition to Emergency Use Authorization clearances for 15 COVID-19 tests, the FDA cleared a number of other non-coronavirus tests via its standard pathways. Here’s the rundown of key new approvals … [Read more...]
Focus On
FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests
March 30, 2020
The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]
Emerging Tests
How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed
March 24, 2020
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...]
