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...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Referral Arrangement Violates Kickback Laws Even If Even Only Purpose Is to Generate Illegal Referrals Case: The U.S. Attorney accused a Kentucky physician of taking a $105 per beneficiary payment … [Read more...]

Data

Genomic Testing Utilization Is Low & Geographically Inconsistent but Not Just Due to Payor Coverage

Genomic testing is inconsistently utilized in the U.S., even in states with favorable coverage policies. Those are the findings of a report from the Personalized Medicine Coalition (PMC) released in … [Read more...]


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