Emerging Markets

The Money to Be Made on New SARS-CoV-2 $erology Test Products

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

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

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

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

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...]

Emerging Tests

Inside the FDA’s Four-Armed COVID-19 Test Response Strategy

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

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

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

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...]