This timeline represents both major milestones ( 
) and details ( 
) 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
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
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
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
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
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
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
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
March 24, 2021
Becton, Dickenson, and Co. receives FDA EUA for POC multiplex test(COVID and Flu)
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
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
October 21, 2021
Xtrava, Inc. receives FDA EUA for POC test
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
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
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
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
October 2024
Oct 7, 2024
Healgen Scientific, LLC receives FDA de novo authorization 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.