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FDA Authorizes First Direct-to-Consumer COVID-19 Test System
americanpharmaceuticalreview
December 11, 2020
The U.S. Food and Drug Administration (FDA) authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription.
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FDA Authorizes COVID-19 Test for Self-Testing at Home
americanpharmaceuticalreview
November 26, 2020
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and provides rapid results.
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The Doc Announces New Rapid Detection SARS-CoV-2 Antibody Test Kit, Plans to Alleviate COVID-19 Testing Delays
prnewswire
October 22, 2020
The Doc, LLC. announced the development of a new rapid detection serological antibody test kit for SARS-CoV-2, the virus that causes COVID-19. With results in minutes using only a drop of blood, the Company's IgM/IgG antibody test has been submitted for..
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FDA Authorizes First Point-of-Care Antibody Test for COVID-19
americanpharmaceuticalreview
October 09, 2020
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.
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Curative Researchers Initiate Research Study to Test Efficacy of Self-Collected COVID-19 Tests
prnewswire
September 30, 2020
COVID-19 testing startup Curative, Inc. announced the launch of a new COVID-19 study in the City of San Antonio.
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Access to coronavirus tests should be ‘top priority’, says NHS Confederation director
pharmatimes
September 21, 2020
Following the latest NHS Test and Trace figures, NHS Confederation director Layla McCay said that access to testing should be a ‘top priority’ for the government ahead of a potential second wave in the UK.
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A New Test Could Identify COVID-19 Patients Who Are at Risk for Severe Illness
prnewswire
September 18, 2020
A novel study in AACC's Clinical Chemistry journal shows that a new test for SARS-CoV-2 viral proteins known as antigens could determine which COVID-19 patients are most likely to become critically ill.
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FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
americanpharmaceuticalreview
August 31, 2020
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
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Over 617,700 COVID-19 test samples collected in Shenzhen
chinadaily
August 22, 2020
More than 617,700 nucleic acid test samples have been collected in the city of Shenzhen, South China's Guangdong province, as part of the latest batch of COVID-19 testing since a new case was detected earlier this month, authorities said on Aug 20.
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Co-Diagnostics, Inc. Receives Enhanced U.S. Patent Protection for CoPrimer Technology Used in COVID-19 Test
prnewswire
August 21, 2020
Co-Diagnostics, Inc. announced that the United States Patent and Trademark Office has granted increased patent protection for the Company's COVID-19 test kit and its other molecular diagnostic tests.