COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Issues Update on Its Support of Medical Products Affected by SARS-CoV-2 Variants

FDA maze of regulations
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FDA addresses how clinical laboratories may be affected by SARS-CoV-2 variants and how the FDA is responding to these challenges

The US Food and Drug Administration (FDA) issued an update on its work to support medical products that could be affected by SARS-CoV-2 variants. This update addressed multiple areas of healthcare that could be affected by new viral variants, but specifically discussed therapeutics, diagnostics, and vaccines.

Clinical laboratories will be most affected by the FDA’s update on diagnostics. “We have been monitoring for new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them, and communicating with the public when helpful information becomes available,” the FDA update says. “At this time, we believe the risk that the currently known mutations will impact overall testing accuracy of molecular tests is low. Moving forward, we are considering expanding the role of in silico monitoring by sponsors prior to and following authorization to assess for mutations that impact the performance of the test, test designs to minimize the impact of new mutations and ways to label authorized products to be transparent about what we know the test can detect.”

The FDA also addressed emerging evidence that virus-targeting monoclonal antibodies may be less effective against variants and concerns that new variants may eventually affect vaccine efficacy.

Clinical laboratory leaders wishing to view the FDA update in its entirety can do so here.

Related Resource:

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group