NIBIB RADx® Tech Timeline

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This timeline represents both major milestones ( blue icon representing major milestones in the RADx Tech program ) and details ( orange icon representing detailed an-events ) for the RADx® Tech program. 

 

 

April 2020

RADx® initiative launches

April 24, 2020

P.L. 116-139 Paycheck Protection Program and Health Care Enhancement Act is signed into law; provides funding for RADx initiative

April 29, 2020

RADx® initiative launches

Press Release

May-June 2020

Projects submitted and review process begins; 400 proposals were started in the first 24 hours

July 22, 2020

RADx® initiative leadership publishes NEJM article

July 31, 2020

$248.7 million awarded for seven Phase 2 contracts for POC and Lab testing

Press Release

August 2020

A total of 716 applications are submitted

August 11, 2020

Submission portal closes due to overwhelming response

September 2020

More than 16 million tests produced this month

September 2, 2020

$129.3 million awarded for nine Phase 2 contracts for POC and Lab testing

Press Release

October 2020

More than 19 million tests produced this month

October 2, 2020

Quidel Sofia ITAP support leads to Quidel: Sofia Inc FDA EUA for rapid antigen multiplex test (COVID and flu)

October 6, 2020

$98.4 million awarded for six Phase 2 contracts for POC and Lab testing

Press Release

October 15, 2020

Sonic receives FDA EUA for multiplex assay of COVID-19 and influenza

October 22, 2020

Helix OpCo receives FDA EUA for lab-based test and sequencing test

October 28, 2020

Illumina receives FDA EUA for lab-based test

November 2020

More than 21 million tests produced this month

November 6, 2020

UCLA Octant receives FDA EUA for lab-based test

December 2020

More than 24 million tests produced this month

December 7, 2020

Luminostics, Inc. receives FDA EUA for POC test

When to Test website launches

Press Release

December 15, 2020

  • Ellume is the first over-the-counter (OTC) home test to receive FDA EUA | Press Release
  • Mesa enters agreement with NBA to test players, staff and coaches

December 17, 2020

MatMaCorp receives FDA EUA for POC test - EUA revoked Aug. 3, 2021

December 22, 2020

Quidel receives FDA EUA for QuickVue POC test

 

January 2021

More than 34 million tests produced this month

January 5, 2021

Illumina and Helix collaborate with CDC to develop national surveillance infrastructure for COVID-19 variants

Quanterix receives FDA EUA for lab-based test

January 7, 2021

Mesa Biotech, Inc. receives FDA EUA for POC test

January 21, 2021

$36.7 million awarded for three Phase 2 contracts for POC testing and Lab Products

Announcement

February 2021

More than 51 million tests produced this month

February 2021

  • DOD awards Ellume $231.8 million contract to increase test production
  • Study to evaluate at-home testing using the My Data Helps app launches
  • Aegis announces expansion of diagnostic testing with Walgreens at more than 3,000 locations

February 8, 2021

ITAP support leads to Visby Medical FDA for POC multiplex test (COVID-19 and flu)

February 26, 2021

Fluidigm Corp., Inc. receives FDA EUA for lab-based test

March 2021

More than 65 million tests produced this month

March 1, 2021

Quidel QuickVue at-home test with prescription receives FDA EUA, will be used to evaluate at-home testing app

Press Release

March 5, 2021

Implementation guide and K-12 playbook added to the When to Test website

Broad Institute receives FDA EUA for lab-based test

March 23, 2021

$29.3 million awarded for four Phase 2 contracts for POC and Lab testing

Announcement

March 24, 2021

Becton, Dickenson, and Co. receives FDA EUA for POC multiplex test(COVID and Flu)

March 31, 2021

NIH-CDC self-testing intervention launches

Press Release

April 2021

More than 71 million tests produced this month

April 13, 2021

Qorvo receives FDA EUA for POC test

April 15, 2021

PathGroup receives FDA EUA for lab-based test

April 20, 2021

PathogenDx receives FDA EUA for lab-based test

April 23, 2021

$65 million awarded for four Phase 2 contracts for POC, home testing, and wastewater surveillance

Announcement

April 29, 2021

RADx® initiative is one-year old

May 2021

More than 105 million tests produced this month

May 19, 2021

$3 million award for one Phase 2 contract for POC and home test

June 2021

More than 120 million tests produced this month

June 7, 2021

RADx® Tech II solicitation opens. Closed on June 28, 2021.

A total of 100 applications were submitted.

July 2021

More than 146 million tests produced this month

July 8, 2021

Ellume receives FDA EUA for lab-based test

July 16, 2021

GenBody, Inc. receives FDA EUA for OTC antigen test; supported by RADx Tech and RADx ITAP

August 2021

More than 151 million tests produced this month

August 24, 2021

Becton, Dickinson and Co. receives FDA EUA for OTC antigen test

Sept. 2021

More than 164 million tests produced this month

Sept. 1, 2021

$13 million award for one Phase 2 contract for lab-based test to detect variants

September 24, 2021

ANP Technologies receives FDA EUA for POC test

Oct. 2021

More than 164 million tests produced this month

October 14, 2021

$77.7 million awarded for 12 Phase 2 contracts for new types of home and POC testing

Press Release

October 21, 2021

Xtrava, Inc. receives FDA EUA for POC test

October 27, 2021

Announcement of the Independent Test Assessment Program (ITAP)

Press Release

October 28, 2021

Detect, Inc. receives FDA EUA for POC test

Nov. 2021

More than 181 million tests produced this month

November 5, 2021

Tails Biomedical receives FDA EUA for lab-based test

November 9, 2021

Meridian Biosciences receives FDA EUA for lab-based test

Dec. 2021

More than 189 million tests produced this month

December 29, 2021

ITAP support leads to Siemens and Roche FDA EUA for rapid OTC tests

Press Release

 

Jan. 2022

More than 220 million tests produced this month, of these 45 million are ITAP-supported

January 19, 2022

ITAP support leads to Maxim Biomedical FDA EUA for rapid OTC test

January 21, 2022

Mammoth Biosciences receives FDA EUA for lab-based test

Feb. 2022

More than 283 million tests produced this month, of these 111 million are ITAP-supported

February 8, 2021

Uh-Oh Labs receives FDA EUA for POC test

March 2022

More than 280 million tests produced this month, of these 128 million are ITAP-supported

March 15, 2022

Minute Molecular receives FDA EUA for POC test

April 2022

More than 522 million tests produced this month, of these 342 million are ITAP-supported

April 6, 2022

ITAP support leads to OSANG, LLC and Xiamen Boson Biotech Co., Ltd. FDA EUA for rapid OTC tests

April 11, 2022

Detect receives FDA EUA for OTC molecular test

April 14, 2022

MicroGem US, Inc. receives FDA EUA for POC molecular test

May 2022

More than 500 million tests produced this month, of these 331 million are ITAP-supported

May 3, 2022

Mobile Applications Reporting through Standards (MARS) program begins collecting results of at-home tests from manufacturers. MARS program information.

June 2022

More than 531 million tests produced this month, of these 350 million are ITAP-supported

July 2022

More than 528 million tests produced this month, of these 349 million are ITAP-supported

July 8, 2022

ITAP support leads to FDA EUA for Watmind, USA for OTC molecular test

August 2022

More than 524 million tests produced this month, of these 349 million are ITAP-supported

Sept 2022

More than 482 million tests produced this month, of these 310 million are ITAP-supported

Sept. 8, 2022

Announcement of Tech III solicitations. Application period is Sept. 20 - Oct. 31 (NEW deadline)

Oct 2022

More than 470 million tests produced this month, of these 299 million are ITAP-supported

Nov 2022

More than 450 million tests produced this month, of these 299 million are ITAP-supported

Nov 17, 2022

ANP Technologies receives FDA EUA for OTC antigen test; supported by RADx Tech and RADx ITAP

Nov 21, 2022

ITAP support leads to Azure Biotech, Inc. FDA EUA for rapid OTC pen test

CorDx, Inc. receives FDA EUA for OTC, rapid antigen test 

Nov 22, 2022

Launch of the Make My Test Count at-home test reporting website

Press release

ITAP support leads to Lucira Health Inc. FDA EUA for POC multiplex test (COVID-19 and flu)

Dec 2022

More than 420 million tests produced this month, of these 260 million are ITAP-supported

 

Jan 2023

More than 431 million tests produced this month, of these 260 million are ITAP-supported

Jan 5, 2023

Launch of Home Test to Treat program

Press release

Feb 2023

More than 430 million tests produced this month, of these 260 million are ITAP-supported

February 8, 2023

ADL Diagnostics (formerly Anavasi Diagnostics) received FDA EUA for POC molecular test

Feb 17, 2023

GenBody, Inc. receives FDA EUA for OTC rapid, antigen test; supported by RADx Tech and ITAP

Feb 22, 2023

Mologic, Inc. receives FDA EUA for OTC antigen test; supported by RADx Tech and ITAP

March 2023

More than 230 million tests produced this month, of these 100 million are ITAP-supported

April 2023

April 14, 2023

Azure Biotech, Inc. receives FDA EUA for OTC rapid, antigen test; supported by ITAP

April 24, 2023

ITAP support leads to Princeton Biomeditech FDA EUA for OTC antigen test; supported by RADx Tech and RADx ITAP

June 2023

June 15, 2023

Lucira by Pfizer, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B molecular test; supported by RADx ITAP

August 2023

August 16, 2023

Visby Medical, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B molecular test; supported by RADx ITAP

 

February 2024

February 29, 2024

SEKISUI Diagnostics, LLC receives FDA EUA for POC and OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP

March 2024

March 21, 2024

CorDx, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP

OSANG, LLC receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP

April 2024

April 3, 2024

OSANG, LLC receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP

April 5, 2024

CorDx, Inc. receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP

April 19, 2024

Wondfo USA Co., Ltd. receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech ITAP

April 30, 2024

Wondfo USA Co., Ltd. receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech ITAP

May 2024

May 7, 2024

iHealth Labs, Inc. receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx ITAP

May 8, 2024

Watmind USA receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP

May 24, 2024

Watmind USA receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP

May 31, 2024

iHealth Labs, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx ITAP

June 2024

June 10, 2024

Healgen Scientific, LLC receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx ITAP

More updates to come as the RADx® Tech program continues.

Note, the number of tests produced per month will no longer be updated as of March 2023.

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