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 EUA for First Home Collected COVID-19 Antibody Test

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COVID-19 antibody test gets the first EUA allowing at-home collected antibody testing

The US Food and Drug Administration (FDA) has issued the first-ever emergency use authorization (EUA) for a home collected COVID-19 antibody test. While many EUAs exist for at-home collection COVID-19 diagnostic tests, this EUA marks the first time that antibody testing can be offered this way. The new EUA was issued for the Symbiotica COVID-19 Self-Collected Antibody Test System.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeffrey Shuren, MD, JD, Director of the FDAs Center for Devices and Radiological Health. The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.

The Symbiotica test allows consumers to collect blood using a finger stick, then send the dried sample to Symbiotica for laboratory analysis. As the first at-home collected COVID-19 antibody test to receive an EUA, the Symbiotica test is the first time a COVID-19 antibody test has moved out of exclusively being collected in a healthcare environment. This development may signal a move toward more consumer-friendly antibody testing.

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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