Public Health

U.S. Needs 200 Million COVID-19 Screening Tests Per Month to Reopen Safely, Says New Report

How many COVID-19 screening tests per month will it take for the U.S. to reopen safely? One new report estimates the number as around 200 million, which is far below the 25 million tests currently … [Read more...]

Enforcement Trends

After 5 Down Years, Federal Enforcement ROI Increases—But Just a Tad

Like any other business, federal health care fraud law enforcement has to account for its return on investment (ROI). And for the previous six years, that ROI had been in steady decline. But ROI … [Read more...]

LDTs

Battle of the SARS-CoV-2 Antibody Immunoassays: Only One Test Meets Both UK Sensitivity and Specificity Targets

Several of the world’s biggest testing companies have created and secured emergency regulatory clearance for immunoassays that detect antibodies to the SARS-CoV-2 virus. But how reliable are these … [Read more...]

Market Trends

COVID-19 Fuels Massive & Sustainable Growth in Molecular Diagnostics

While it may be decimating demand for most lab tests, COVID-19 is driving incredible growth in molecular testing. The global market for molecular diagnostics will top $13 billion in 2020, about $5 … [Read more...]

Compliance Perspectives 

How to Create and Implement a Mandatory Face Mask Policy at Your Lab Facilities  

What began as a CDC guideline is evolving into a legal duty with more than 20 states and countless municipalities across the country adopting laws requiring individuals to wear masks or face coverings … [Read more...]

Labs In Court

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

Magnolia Wins Round One of False Advertising Suit against Rival Collection Device Maker Case: Score one, maybe two, for Magnolia Medical Technologies, Inc. in its ongoing litigation war with rival … [Read more...]

Labs In Court

Magnolia Wins Round One of False Advertising Suit against Rival Collection Device Maker

Case: Score one, maybe two, for Magnolia Medical Technologies, Inc. in its ongoing litigation war with rival blood and bodily fluid collection device maker Kurin, Inc. In addition to patent … [Read more...]

Labs In Court

Failure to Redo “Error” Message A1c Test on Diabetic Patient ≠ No-Brainer Medical Malpractice

 Case: A patient with Type 2 diabetes presented to a federal health clinic with normal heart function, clear lungs and no swelling. And since he didn’t complaint about light-headedness or dizziness, … [Read more...]

Diagnostics Deals

Global Non-Profit & Smartphone DX Firm to Create Malaria Diagnosis App

Malaria continues to wreak havoc around the world, particularly in low- and middle-income countries (LMICs). Although rapid in vitro diagnostic tests (RDTs) for malaria are widely used in those … [Read more...]

M&A Report

Invitae-ArcherDX Merger to Create Precision Oncology Powerhouse

While M&A deal volume remains abnormally low, business is expected to pick up this summer as the reopening process gets into high gear. Meanwhile, a few new deals are being made, including … [Read more...]


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