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Topic: Coronavirus Test

Co-Diagnostics, Inc Receives FDA Emergency Use Authorization for COVID-19 Test

 

Co-DiagnosticsSalt Lake City, NVCo-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.

Co-Diagnostics technician sets up a plate for the CoDx Box thermocycler

Co-Diagnostics technician sets up a plate for the CoDx Box thermocycler

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FDA Coronavirus (COVID-19) Update for April 2nd, 2020

 

U.S. Food and Drug Administration - FDASilver Spring, MD – On Thursday, April 2nd, 2020, the U.S. Food and Drug Administration (FDA) announced the following actions taken in its ongoing response effort to the Coronavirus (COVID-19) pandemic:

The FDA announced that it is revising recommendations in several guidances regarding blood donor eligibility. These changes are based on recently completed studies and epidemiological data, leading the FDA to conclude that the polices could be modified without compromising the safety of the blood supply.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update for April 1st, 2020

 

U.S. Food and Drug Administration - FDASilver Spring, MD – Last Wednesday, April 1st, 2020, the U.S. Food and Drug Administration (FDA) announced the following actions taken in its ongoing response effort to the Coronavirus (COVID-19) pandemic.

FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available: In response to the Coronavirus (COVID-19) pandemic, the FDA—in collaboration with the U.S. Centers for Disease Control and Prevention (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI)—developed quality-controlled, reference sequence data for the SARS-CoV-2 reference strain for the United States.

Coronavirus

Coronavirus

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COVID-19 Unified Command reports Actions Taken in Gallatin Center for Rehabilitation Coronavirus Outbreak

 

Tennessee State GovernmentNashville, TN – Tennessee Governor Bill Lee’s COVID-19 Unified Command announced the following actions taken for a coronavirus (COVID-19) outbreak at the Gallatin Center for Rehabilitation and Healing. Unified Command is a joint operation between the Tennessee Department of Health, Tennessee Department of Military and the Tennessee Emergency Management Agency (TEMA).

Coronavirus

Coronavirus

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Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes

 

AbbottAbbott Park, IL –  Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.

The test will run on the company’s ID NOW platform, providing rapid results in a wide range of healthcare settings such as physicians’ offices, urgent care clinics and hospital emergency departments.

Testing being performed on Abbott’s ID NOW platform.

Testing being performed on Abbott’s ID NOW platform.

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101st Airborne Division, Fort Campbell commander Maj. Gen. Brian Winski reviews BACH’s Coronavirus response preparations

 

Blanchfield Army Community Hospital Public Affairs

Blanchfield Army Community Hospital (BACH)Fort Campbell, KY – The Commanding General for 101st Airborne Division (Air Assault) and Fort Campbell, Maj. Gen. Brian Winski, visited Blanchfield Army Community Hospital Tuesday, March 24th, 2020 for a first-hand look at the hospital’s preparations to respond to the coronavirus, COVID-19 pandemic.

The hospital established a drive-up clinic outside the hospital for patients with appointments and referred by the Nurse Advice Line or BACH’s Appointment Line. During this screening process, medical staff may conduct additional screening to determine if a test is necessary. Once a test for coronavirus (COVID-19) is administered, it is sent out for processing and patients with mild symptoms are advised to self-quarantine at home while awaiting test results.

BACH Commander Col. Patrick T. Birchfield (right) leads 101st Airborne Division (Air Assault) and Fort Campbell Commanding General, Maj. Gen. Brian Winski (left) to a drive-up clinic established outside the hospital where medical staff are seeing patients referred for possible coronavirus, COVID-19 related symptoms. The general visited BACH for a first-hand look at the hospital’s many preparations to respond to the coronavirus, COVID-19 pandemic. (U.S. Army photo by Maria Yager)

BACH Commander Col. Patrick T. Birchfield (right) leads 101st Airborne Division (Air Assault) and Fort Campbell Commanding General, Maj. Gen. Brian Winski (left) to a drive-up clinic established outside the hospital where medical staff are seeing patients referred for possible coronavirus, COVID-19 related symptoms. The general visited BACH for a first-hand look at the hospital’s many preparations to respond to the coronavirus, COVID-19 pandemic. (U.S. Army photo by Maria Yager)

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FDA Issues first Emergency Use Authorization for Point of Care Coronavirus Diagnostic

 

U.S. Food and Drug Administration - FDASilver Spring, MD –  The U.S. Food and Drug Administration (FDA) has issued the first emergency use authorization for a point-of-care coronavirus (COVID-19) diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30th, which is an incredibly rapid timeline for such an effort,” said HHS Secretary Alex Azar

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FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

 

U.S. Food and Drug Administration - FDASilver Spring, MDThe U.S. Food and Drug Administration (FDA) is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.

As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for coronavirus (COVID-19) in the home.

Coronavirus

Coronavirus

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Latest from the White House on Coronavirus response

 

The White HouseWashington, D.C. – President Donald Trump and the White House Coronavirus Task Force announced additional actions today, Friday, March 20th, 2020 as part of the ongoing, government-wide response to the global coronavirus (COVID-19) pandemic:

To help American families and businesses, the Treasury Department announced that Tax Day will be moved from April 15th to July 15th. No interest or penalties will be charged for filing during this extended window, but any American expecting refunds or credits may claim now to get their money sooner.

President Donald Trump leads a teleconference with Governors at FEMA Headquarters to discuss the Coronavirus response. (White House)

President Donald Trump leads a teleconference with Governors at FEMA Headquarters to discuss the Coronavirus response. (White House)

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Montgomery County Health Department traffic pattern at Veteran’s Plaza for Coronavirus Testing

 

Montgomery County Government TennesseeClarksville, TN – The Montgomery County Health Department is operating a drive-thru testing site for Coronavirus (COVID-19 for individuals experiencing fever, cough, and shortness of breath. Follow the signs when you enter the parking lot.

Please see the graphic below for the new traffic pattern for visitors to the Montgomery County Health Department at Veteran’s Plaza.

Montgomery County Health Department traffic pattern map

Montgomery County Health Department traffic pattern map

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