LDTs

HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization

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...]

TOOL: Mandatory Mask and Face Covering Policy

More than 20 states have enacted laws requiring the use of face masks or coverings in indoor public places, which would include workplaces like medical testing labs. Here’s a Model Policy … [Read more...]

Test Utilization

Rapid Testing the Linchpin of COVID-19 Contact Tracing Effectiveness

Without rapid testing and results, COVID-19 contact tracing will not work. That is the conclusion of a new study published in The Lancet. Even the most efficient contact tracing strategy will not … [Read more...]

Inside the Beltway

President Calls for Cutting NIH Budget but Congress Increases It Instead

The Trump administration wanted to slash the National Institutes of Health (NIH) budget but Congress wouldn’t allow it. It’s been the same narrative for the past four years. But even though it’s … [Read more...]

COVID-19

Strapped by COVID-19 Testing Supply Shortages, Labs Call on White House for Help

Reagent shortages and supply chain bottlenecks have stymied COVID-19 testing from the very beginning of the crisis. As those problems remain and tests provided slips further behind demand, a handful … [Read more...]

Reimbursement

Not Making Insurers Pay for Back-to-Work COVID-19 Testing May Leave Labs Holding the Bag

Who should pay for desperately needed COVID-19 testing? In the first stage of the public health crisis, the federal government’s answer was that insurers should pay the bills and not pass along the … [Read more...]

LDTs

FDA Provides New Guidance on Validation of Sample Pooling for SARS-CoV-2 Test Development   

On June 16, the FDA issued new guidance to help labs and commercial manufacturers use test sample pooling to develop, validate and acquire Emergency Use Authorization (EUA) of qPCR-based SARS-CoV-2 … [Read more...]

Tool

Model COVID-19 Contact Log Sheet

Maintaining social distancing will be the price that labs and other businesses will have to pay to reopen and remain open until the COVID-19 threat goes away. But for social distancing to work, there … [Read more...]

Compliance Briefing

How to Comply with the New HHS COVID-19 Test Data Reporting Rules

The U.S. Department of Health and Human Services (HHS) has ordered labs that perform COVID-19 testing to report test data to state and local public health agencies by August 1, 2020. What makes the … [Read more...]

GAO Report

Federal COVID-19 Testing Data Collection Effort Has Been Ineffective

The federal government has done a poor job of collecting and reporting COVID-19 testing data to the CDC since the pandemic began. That’s the conclusion of a U.S. Government and Accountability Office … [Read more...]


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