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...]
The Business of Testing
HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19
November 24, 2020
Top of the News
Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing
September 3, 2020
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
June 23, 2020
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
April 19, 2020
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
March 20, 2020
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...]
TESTING TRENDS
Genetics Update: 23andMe Seeks to Upend the Medical Industry via Genetic Testing Information Sharing
August 27, 2019
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...]
TESTING STRATEGY
Upfront Next-Generation Sequencing for Lung Cancer Patients Saves Time, Money
August 5, 2019
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...]
GENETIC TESTING
Guidelines at a Glance
July 22, 2019
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...]
TESTING STRATEGY
Preventive Genomic Screening In Young Adults Highly Cost Effective
March 26, 2019
A new model shows that universal preventive genomic screening for multiple conditions in early adulthood could be highly cost-effective in a single-payer health care system, according to a study … [Read more...]
EMERGING TESTS
Study Showing PGx Testing Improves Depression Outcomes, Key to Myriad’s Reimbursement Strategy
February 18, 2019
Pharmacogenomic testing (PGx) provides clinically meaningful improvement in response and remission rates for difficult-to-treat depression patients over standard of care, according to a study … [Read more...]
