FDA Watch

Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be … [Read more...]

DX Deals

Eurofins Teams with Uber for Home Delivery of COVID-19 Test Kits

At-home COVID-19 testing and sample collection is becoming so big that it’s drawing players from outside the lab testing market. And it’s not just the Walgreens, Walmarts, Amazons and other retailers … [Read more...]

Special Report

A New Administration Takes a Totally Different Approach to COVID-19 Testing

Fair or unfair, the general perception has been that the White House has been less than fully supportive of COVID-19 testing efforts during the pandemic. On Jan. 21, his first full day in office, … [Read more...]

Special Focus

CBC Scoring of COVID-19 Inpatients May Help Hospitals Save Lives and Preserve Precious Treatment Resources

Early detection and early intervention have the potential to improve the prospects of recovery and positive outcomes for a broad range of diseases, including coronavirus. And now researchers in Europe … [Read more...]

Labs In Court

LabCorp Can Sue Physician to Collect $117K Worth of “Pass-Through” Charges for Uninsured Patients

Case: Labs like LabCorp typically enter “pass-through” arrangements with physicians covering patients that lack insurance or are otherwise self-pay. The way it works: The lab bills the physician who … [Read more...]

FDA Watch

Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit

Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for … [Read more...]

The Quest Case and Medical Malpractice Liability Risks of Genetic Testing Labs

For years, Quest Diagnostics has been embroiled in a poignant lawsuit testing the liability of genetic labs for faulty DNA test results. In 2018, Quest struck a decisive blow by getting the South … [Read more...]

Compliance Perspectives

Can You Require Lab Workers to Get the COVID-19 Vaccination?

Although it’s clearly a positive development for the world at large, the almost miraculous emergence of a vaccine for COVID-19 in less than a year poses legal challenges for employers in general and … [Read more...]

Emerging Tests

New Collaboration Seeks to Develop Handheld Breathalyzer Test for COVID-19

A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a major breakthrough in the effort to contain the spread of the virus. That … [Read more...]

Inside the Lab Industry

Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market

What COVID-19 antigen assays lack in accuracy with regard to RT-PCR testing is offset by their speed, low cost and scalability. In the long term, these advantages make point-of-care COVID-19 antigen … [Read more...]