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...]
Consumer Fraud
OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams
January 6, 2021
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...]
Compliance Perspectives
Can You Require Lab Workers to Get the COVID-19 Vaccination?
January 6, 2021
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
January 6, 2021
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
January 6, 2021
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...]
Lab Safety
What will 2021 bring for lab safety programs?
December 28, 2020
By Dan Scungio bio As we say goodbye and good riddance to the year 2020, we hesitatingly welcome 2021. What will the new year bring? Can it be worse than the last year? Are we prepared to deal with … [Read more...]
Innovation
New Saliva-Based CRISPR Smartphone Assays May Fill Need for Mass and Rapid COVID-19 Testing
December 28, 2020
One of the few positive things to come out of this deadly global pandemic is how it has accelerated the pace of diagnostic innovation to hyperdrive levels. The latest example of this phenomenon is the … [Read more...]
Industry Buzz
HHS to FDA: Resume EUA Review of COVID-19 LDTs, And Do It Fast
December 1, 2020
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 crisis. Sadly, it seems … [Read more...]
