The controversy over FDA Emergency Use Authorization (EUA) of laboratory developed tests (LDTs) for COVID-19 is on high boil once more. A month after the agency announced it would no longer review … [Read more...]
REIMBURSEMENT
Labs and Private Payors Clash Over Reimbursement of COVID-19 Testing
November 27, 2020
Things are getting ugly. The unfortunate convergence of resurgent COVID-19 cases, lingering testing supply bottlenecks and Thanksgiving are once more stretching labs to the breaking point and fraying … [Read more...]
Consumer Fraud
OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams
November 27, 2020
Pharma companies, diagnostics manufacturers, labs and other parts of the healthcare industry have done a commendable job in pivoting in response to the current public health industry. Sadly, it seems … [Read more...]
Lab Safety
“COVID captains” promote safety precautions
November 25, 2020
By Dan Scungio bio The year 2020 is roaring to a close, and COVID-19 is unfortunately still around. We have made changes to our lives at home, in public, and at work. Lab workers and other … [Read more...]
Emerging Tests
Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub
November 24, 2020
The rapid evolution of COVID-19 testing in response to the need for speed and mobility continues. One notable development on the antigen testing front is Qiagen’s U.S. rollout of a portable digital … [Read more...]
DTC
Research Supports Viability of Using Health Data from Consumer Wearables to Diagnose COVID-19
November 24, 2020
That Fitbit, smartwatch or other device that many of us wear around our wrist to count our steps, calories burned and other fitness metrics on a daily basis may prove to be an ideal tool for … [Read more...]
NPR Report
CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis
November 24, 2020
Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public … [Read more...]
The Business of Testing
HHS Orders FDA to Resume EUA Review of Laboratory Developed Tests for COVID-19
November 24, 2020
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...]
COVID-19
CDC Knowingly Shipped Flawed COVID-19 Test Kits to Public Labs in Early Days of Crisis, Says Report
November 17, 2020
Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public … [Read more...]
