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NIBIB’s RADx Tech program announcement
NIBIB’s RADx Tech program has issued two new funding opportunities for diagnostic test manufacturers to develop COVID-19 tests that are accessible to people with disabilities and tests with improved performance. Applications will be accepted on a rolling basis starting on September 20, 2022 that is currently planned to continue until October 14, 2022. See links…
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![RADx Tech Webinar: Beyond Epitope Mapping]()
RADx Tech Webinar: Beyond Epitope Mapping
For those interested, there is a RADx Tech Webinar Series on Tuesday April 19th at 11am Pacific/2pm Eastern Time: Beyond Epitope Mapping: Using Deep Mutational Scanning to Generate a Complete Map of SARS-CoV-2 Diagnostic Antibody Escape Mutations Link to register: Click here to register by April 18th
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![Guidance Update 11/15/21: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)*]()
Guidance Update 11/15/21: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)*
News announcement: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-test-policies-help-ensure-accuracy-and-reliability-tests-and
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![Diagnostics Core Office Hours “Predictive Values” session POSTPONED to 9/29/21]()
Diagnostics Core Office Hours “Predictive Values” session POSTPONED to 9/29/21
The Predictive Values Calculations session during Diagnostics Core Office Hours (originally planned for September 15 at 10:00am PT) has been postponed to Wednesday, September 29. Dr. Aronoff-Spencer is on clinical service and with the high number of COVID cases in San Diego, he is unable to participate. There will still be Diagnostic Core Office Hours…
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![RADx Tech Work Package Application *update 10/18/21]()
RADx Tech Work Package Application *update 10/18/21
RADx-rad and RADx Tech has created a pathway for project teams who are close to commercializing their technologies/products. Attached is an information packet for you to review and discuss with your team and RADx-rad Program Officer if you feel you are ready to take the step to commercialization. In the packet, there is a self-assessment…
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![Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection]()
Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a temperature reading that does not meet criteria for fever. Read more
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![FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process]()
FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
BioFire Respiratory Panel 2.1 is the First COVID-19 Diagnostic Test Granted Marketing Authorization Using the De Novo Review Pathway. Read more
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![Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs]()
Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs
The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health. Ream more
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![Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test]()
Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular…
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![A New Coronavirus Variant Is Spreading in New York]()
A New Coronavirus Variant Is Spreading in New York
The variant, B.1.526, contains a mutation thought to help the virus dodge the immune system, scientists said. Read more
