Global Markets

EC Announces New Plan to Roll Out In Vitro Diagnostic Regulation

If your laboratory company does business in Europe, it needs to be tuned in to the dramatic regulatory changes that are slated to go into effect in 2022. The key date is May 26 when the European … [Read more...]

The Business of Testing

Hospital Laboratories Take a Stand Against Controversial UnitedHealthcare Outpatient Reimbursement Policy

The cold war between hospital laboratories and the nation’s third largest health insurer, UnitedHealthcare (UHC), over reimbursement of diagnostic tests is getting hotter by the day. At the center of … [Read more...]

The Business of Testing

HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19

Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers … [Read more...]

Top of the News

Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing

Free COVID-19 testing is a powerful and very compelling policy. The problem, of course, is that somebody has to pay for coronavirus testing. And the insurance companies have been designated as that … [Read more...]

The Business of Testing

Pandemic Energizes Search for Genomics-Based Early PTSD Detection Diagnostics

COVID-19 is destroying not only lives and the economy but also mental health. The global pandemic is widely expected to result in a dramatic increase in post-traumatic syndrome disorder (PTSD) cases. … [Read more...]

The Business of Testing

New COVID-19 Revenues Not Enough to Offset Declines in Elective & Screening Tests

That line from Charles Dickens’ A Tale of Two Cities about the best of times and the worst of times is especially apt with what testing laboratories in the US and around the world are experiencing. … [Read more...]

Money Talks

Test Utilization: Payment Policies More Effective than Practice Recommendations in Curbing Orders of Low-Value Tests

When it comes to getting physicians not to order low-value laboratory tests, money talks. At least, that is the punchline of a new study finding that changes in payment policies are more effective … [Read more...]


Genetics Update: 23andMe Seeks to Upend the Medical Industry via Genetic Testing Information Sharing

Can one company disrupt the entire lab industry? 23andMe seems determined to find out. The Mountain View, California-based personal genomics and biotechnology company, which first marketed its … [Read more...]


Upfront Next-Generation Sequencing for Lung Cancer Patients Saves Time, Money

Use of upfront next-generation sequencing (NGS) testing at diagnosis of patients with metastatic non-small-cell lung cancer (mNSCLC) is associated with substantial cost savings, according to a study … [Read more...]


Guidelines at a Glance

Screening for HIV Published June 11 in the Journal of the American Medical Association. The U.S. Preventive Services Task Force (USPSTF) recommends screening for HIV infection in adolescents and … [Read more...]