COMMUNICATIONS

COVID-and-person

Extension for NOSI: Advance Data Science Approaches Through Secondary Data Analysis to Reveal Scientific Insights of COVID-19 Testing Technologies

The NIH has announced NOT-OD-24-026: Notice of Special Interest (NOSI): Advance Data Science Approaches Through Secondary Data Analysis to…

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Webinar – CDRH’s New Draft Guidances to Continue to Modernize the 510(k) Program

Summary On October 26, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar for device…

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RADx Tech III Proposal Deadline- EXTENDED to 10/31

The deadline for RADx Tech III proposals has been extended. Proposals may be submitted between September 20 and October…

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FDA Virtual Town Hall Series

The U.S. Food and Drug Administration (FDA) hosts a virtual Town Hall series for SARS-CoV-2 (COVID-19) test developers…

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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…

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NIH Long COVID Computational Challenge (L3C)

The National Institutes of Health, through the Office of the Director, is launching the NIH Long COVID Computational…

REGISTER NOW: Team Science Training 6/2 and 6/9

REGISTER NOW: Team Science Training 6/2 and 6/9

Dear RADx-rad DCC Awardees, teams, Program Officers, and DCC members, Registration for Team Science Training facilitated by Dr.…

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…

Cancelation of all ELSI/IRB Office Hours

Cancelation of all ELSI/IRB Office Hours

Dear RADx-rad Colleagues, We will be canceling all future ELSI/IRB Office Hours starting Wednesday February 16, 2022. An email…

FDA: SARS-CoV-2 mutations impact on COVID-19 tests

FDA: SARS-CoV-2 mutations impact on COVID-19 tests

This page has information about COVID-19 diagnostic tests with relation to viral mutations, such as the Omicron variant.…

Omicron variant update from South African Ministry of Health

Omicron variant update from South African Ministry of Health

The Omicron variant discussed at the South African Ministry of Health press conference recorded on November 25, 2021.…

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

RESCHEDULED: October All-Hands Meeting 10/18

RESCHEDULED: October All-Hands Meeting 10/18

The October Monthly RADx-rad DCC All-Hands Meeting scheduled for October 11th has been rescheduled to October 18th at…

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)…

Anti-Racism Training

Anti-Racism Training

RADx-rad Colleagues, As you know from announcements in recent All-Hands Meetings, RADx-rad DCC is making anti-racism training available…

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.…

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…

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…

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,…

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…

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…

Two studies confirm a new variant in California is more contagious, but the scale of its threat is unclear.

Two studies confirm a new variant in California is more contagious, but the scale of its threat is unclear.

Written by Carl Zimmer RAD-x Rad Awardee Charles Chiu talks about the significance of the California variant. Read…

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests Guidance for Test Developers and Food and Drug Administration Staff

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests Guidance for Test Developers and Food and Drug Administration Staff

Written by U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological…

Editorial: U.S. FDA’s Experience with COVID-19 Antibody Tests

Editorial: U.S. FDA’s Experience with COVID-19 Antibody Tests

Precision Vaccinations: An editorial published by The New England Journal of Medicine (NEJM) highlights ‘establishing robust and coordinated national and…

VIC Foundry, Inc. Receives NIH RADx Funding for Development of an At-home Molecular Diagnostic Test for COVID-19

VIC Foundry, Inc. Receives NIH RADx Funding for Development of an At-home Molecular Diagnostic Test for COVID-19

Written by newsfeed VIC Foundry’s innovative designs for a low-cost at-home COVID-19 test Funding for the project is…

Luminostics Announces FDA Authorization and Production Scale-Up of US-Manufactured Smartphone-Based COVID-19 Rapid Test

Luminostics Announces FDA Authorization and Production Scale-Up of US-Manufactured Smartphone-Based COVID-19 Rapid Test

Written by newsfeed Components of the Clip COVID Test The reusable iPhone-based Clip Analyzer, the Clip COVID iOS…

The FDA’s Experience with Covid-19 Antibody Tests

The FDA’s Experience with Covid-19 Antibody Tests

Written by newsfeed In January 2020, the Food and Drug Administration (FDA) began considering the U.S. response to Covid-19.…