We all understood that the massive spike in COVID-19 testing was unsustainable and bound to gradually peter out. But now it appears that the decline is coming steeper and faster than anybody expected. … [Read more...]
FDA
FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
February 19, 2021
Since the pandemic began, the FDA has granted Emergency Use Authorization (EUA) for more than 250 COVID-19 diagnostic tests. Among these, nearly 30 have received clearance for at-home collection; a … [Read more...]
COVID-19
OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams
December 21, 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, scammers … [Read more...]
Special Report: Long-Awaited Kickback Relief Rules Leave Labs Out in the Cold
December 20, 2020
The final rule for value-based care kickback relief that HHS and the OIG published on Nov. 20 is slightly more favorable to labs than the proposed rule published in October 2019. But with a limited … [Read more...]
Business Trends
Labs Partner with Airlines to Offer COVID-19 Testing to Travelers
November 17, 2020
civCOVID-19 has greatly complicated air travel from country to country and even state to state. While entrance rules vary from place to place, a number of jurisdictions are allowing travelers to avoid … [Read more...]
Public Health
U.S. Needs 200 Million COVID-19 Screening Tests Per Month to Reopen Safely, Says New Report
September 17, 2020
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...]
COVID-19
Strapped by COVID-19 Testing Supply Shortages, Labs Call on White House for Help
July 20, 2020
Reagent shortages and supply chain bottlenecks have stymied COVID-19 testing from the very beginning of the crisis. As those problems remain and tests provided slips further behind demand, a handful … [Read more...]
New Laws
HHS Requires Labs to Report Extensive & Unprecedented COVID-19 Testing Data by August 1
June 17, 2020
Three months into the pandemic, HHS has decided that it would be a good idea for labs that perform COVID-19 testing to report not only test results but other real-time data that labs generally don’t … [Read more...]
The Coronavirus Crisis
Test-Now, Regulate-Later Strategy Generates Robust Dx Test Pipeline in Record Time
April 17, 2020
Historically, the lag between Public Health Emergency (PHE) declaration and FDA approval of a lab test to diagnose the pathogen has been a minimum of eight weeks. Eight weeks into the coronavirus PHE, … [Read more...]
LDTs
Laboratory Developed Tests: The VALID Act is Back
March 18, 2020
With all the attention commanded by the coronavirus crisis, a potentially huge development affecting the future of the lab industry has flown under the radar. What’s at stake is the issue that has … [Read more...]
