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...]

Industry Buzz

COVID-19 Relief Bill Leaves Labs Out in the Cold

Labs who have answered the call to mobilize beyond capacity so that people can be tested for COVID-19 can be forgiven for thinking nobody in Washington “CARES” about them. What else are they supposed … [Read more...]

Employment Law

Coronavirus pushing rapid changes in employer law

By Mike O’Brien bio Employer law is rapidly changing amid the coronavirus pandemic. For one thing, Congress has passed another coronavirus related law. The United States Department of Labor (DOL) … [Read more...]

Industry Buzz

COVID-19 Relief Bill Leaves Labs Out in the Cold

Labs who have answered the call to mobilize beyond capacity so that people can be tested for COVID-19 can be forgiven for thinking nobody in Washington “CARES” about them. What else are they supposed … [Read more...]

Daily Update

FDA Approved Coronavirus Tests

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION (As of April 2, 2020)  Yesterday, North Carolina-based Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test became the first coronavirus serology … [Read more...]

Reimbursement

CDC Issues ICD-10-CM Coding Guidance for Coronavirus Encounters

The U.S. Centers for Disease Control and Prevention (CDC) issued official guidance to labs and other health care providers on which ICD-10-CM diagnosis codes to use for 2019 novel coronavirus … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: Urgent Need for Coronavirus Diagnostics Fuels Strategic Collaboration

Not surprisingly, teaming up for development and commercialization of coronavirus (COVID-19) detection and vaccination products was a major theme of strategic alliance making during the period. … [Read more...]

Coronavirus

How Coronavirus Public Health Emergency Offers Potential for Temporary Stark Relief

On Jan. 31, 2020, the U.S. Department of Health and Human Services declared novel coronavirus, aka, COVID-19, a public health emergency (PHE). While it might sound like the highest level of government … [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...]


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