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...]


Emerging Tests: Progress & Key Developments in the Scramble to Develop a Rapid Coronavirus Detection Test

As coronavirus continues to spread and claim more lives, the development of a quick, safe and effective diagnostic test for detecting the 2019-nCoV virus has become an urgent global priority. Not … [Read more...]

Billing & Coding: Use New HCPCS Code U0001 to Bill Medicare for CDC Coronavirus Test

Good news for labs that are testing Medicare patients for SARS-CoV-2 using the newly approved Centers for Disease Control and Prevention (CDC) 2019 Real Time RT-PCR Diagnostic Test Panel (and … [Read more...]

FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test

Because the 2019 novel coronavirus outbreak was so unanticipated, there were no FDA-approved commercial products for it available in the US during its early days. On Jan. 28, the FDA unveiled its … [Read more...]

Emerging Tests: Lab Industry Mobilizes to Develop Coronavirus Detection Test

The global coronavirus (COVID-19) outbreak came without warning and is having a seismic impact on laboratories and the diagnostics business. The imperative for the industry right now is to develop a … [Read more...]


Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests

The 2019 novel Wuhan coronavirus outbreak caught regulators and diagnostic test makers off guard. As the death toll mounts, the scramble is on to develop tests capable of detecting the virus. Here’s a … [Read more...]

FDA Watch

Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]

Industry Buzz

Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]