FDA Coronavirus COVID-19 Update - - - FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | site |


Test is authorized for individuals two years of age or older, including those not showing symptoms


(Information contained in U.S. Food and Drug Administration [FDA] press release: December 15, 2020)

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-c...

U.S. Department of Health and Human Services Provides $25 Million to Siemens Healthineers to Develop and Produce COVID-19 Antigen Diagnostic Tests | site |


Dual Contracts Will Yield Two New Antigen Tests and Update Massachusetts Facility to Produce up to 50 Million Tests Per Month


(Information contained in U.S. Department of Health and Human Services press release: November 19, 2020) Today, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) awarded Siemens Healthineers a $12 million contract to support domestic production of two diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. The funding is in addition to a $13 million HHS contract awarded Nov. 2 to enable the company to develop the tests. Combined, the two contracts represent another $25 million investment by the federal government to expand the types of tests for COVID-19 and to ensure that sufficient numbers of tests are available ...

U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19 | site |




(March 30, 2020) - - Today (March 30, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

March 30, 2020

Statement From:

Commissioner of Food and Drugs - Food and Drug Administration

Stephen M. Hahn M.D.

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous...

Coronavirus COVID-19 Update - - - FDA Issues first Emergency Use Authorization for Point of Care Diagnostic | site |




(March 21, 2020) - - The U.S. Food and Drug Administration published today (March 21, 2020) the following information:

Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care 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 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” said HHS Secretary Alex Azar. “With the development of point of care diagnostics, Americans who need tests will be able to ...

HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections| site |



(March 18, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information: In response to the now global pandemic, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), continues to work with its public-private partners to find solutions to mitigate the public health impact of the coronavirus disease 2019 (COVID-19). Part of this landscape is the immediate need for diagnostics tests that can quickly and accurately diagnose COVID-19 infections in order to identify the virus and mitigate the spread of the disease. BARDA will provide Mesa Biotech, Inc. of San Diego, California, with technical expertise and $561,330 in immediate funding to pursue eventual Food and Drug Administration (FDA) approval or clearance of its dia...

U.S. Department of Health and Human Services Supports Development of First High-Throughput COVID-19 Diagnostic Test| site |




(March 9, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information:

A diagnostic test for coronavirus disease 2019 (COVID-19) - designed for use in a diagnostic system that can process up to 1,000 tests in 24 hours - will receive advanced development support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR). The molecular diagnostic test from Hologic, Inc. becomes the first COVID-19 product selected for development through ASPR's Biomedical Advanced Research and Development Authority streamlined selection process, called an easy broad agency announcement (EZ-BAA). "Early, rapid diagnosis is essential for clinicians and their patients to treat infections appropriately and take immediate acti...

Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins| site |




Distribution of CDC Diagnostic Test Kits Will Expand Laboratory Capacity to Detect 2019-nCoV


(February 6, 2020) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information: A CDC-developed laboratory test kit to detect 2019 novel coronavirus (2019-nCoV) began shipping yesterday to select qualified U.S. and international laboratories. Distribution of the tests will help improve the global capacity to detect and respond to the 2019 novel coronavirus. The test kit, called the Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCov) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel (CDC 2019-nCoV Real Time RT-PCR), is designed for use with an existing RT-PCR testing instrument that is commonly used to test for seasonal influenza. The CDC 2019 novel coronavirus test is intended for use with upper...

U.S. Food and Drug Administration takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic| site |




FDA says Critical Milestone Reached in Response to this Outbreak



(February 4, 2020) - - Today (February 4, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

Today, the U.S Food and Drug Administration issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and...