2838 lines
94 KiB
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2838 lines
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<a href="/science-education/meet-a-scientist" class="link" data-drupal-link-system-path="node/141721"> <span>Meet a Scientist</span>
|
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|
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|
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<a href="/about-nibib/budget" target="_self" class="link" data-drupal-link-system-path="node/911"> <span>Budget</span>
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<a target="_blank" class="link-list-serve" href="https://public.govdelivery.com/accounts/USNIBIB/subscriber/edit?preferences=true#tab1"> Join LISTSERV
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<a href="/programs" class="usa-breadcrumb__link"><span>Research & Training Programs</span></a>
|
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</li>
|
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|
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<a href="/programs/radx-tech-program" class="usa-breadcrumb__link"><span>RADx® Tech</span></a>
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<span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="https://www.nibib.nih.gov/programs/radx-tech-program/timeline" data-a2a-title="NIBIB RADx® Tech Timeline"><a class="a2a_button_email"><span class="a2a_svg a2a_s_a2a a2a_s_email a2a-box"><img src="/themes/custom/nibib/assets/img/email-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_button_facebook"><span class="a2a_svg a2a_s_a2a a2a_s_facebook a2a-box"><img src="/themes/custom/nibib/assets/img/facebook-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_button_linkedin"><span class="a2a_svg a2a_s_a2a a2a_s_linkedin a2a-box"><img src="/themes/custom/nibib/assets/img/linkedin-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_button_twitter"><span class="a2a_svg a2a_s_a2a a2a_s_x a2a-box"><img src="/themes/custom/nibib/assets/img/x-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span
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</a><a class="a2a_button_whatsapp"><span class="a2a_svg a2a_s_a2a a2a_s_whatsapp a2a-box"><img src="/themes/custom/nibib/assets/img/whatsapp-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_dd addtoany_share"><span class="a2a_svg a2a_s_a2a a2a_s_share a2a-box"><img src="/themes/custom/nibib/assets/img/share-a2a.svg" border="0" alt="Share" width="27" height="27"></span></a></span>
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</div>
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</div>
|
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|
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<div class="">
|
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<div data-drupal-messages-fallback class="hidden"></div>
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|
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|
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</div>
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<div class="grid-row ">
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</div>
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<div class="grid-row grid-gap">
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<div class="usa-layout-docs__main desktop:grid-col-fill">
|
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|
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<div id="block-nibib-page-title" class="block--page-title-block">
|
||
|
||
|
||
<h1 class="margin-0 page-header">
|
||
<span property="schema:name">NIBIB RADx® Tech Timeline</span>
|
||
</h1>
|
||
|
||
</div>
|
||
|
||
<div id="block-nibib-content" class="block block-system block-system-main-block">
|
||
|
||
|
||
|
||
|
||
|
||
|
||
<article data-history-node-id="125156" about="/programs/radx-tech-program/timeline" typeof="schema:WebPage" class="page node--basic-page node--type-page">
|
||
<div>
|
||
|
||
|
||
<div property="schema:text" class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>This timeline represents both major milestones ( <img alt="blue icon representing major milestones in the RADx Tech program" data-entity-type="file" data-entity-uuid="f1f9f596-61f7-41cc-a93f-6d6051c7322b" height="20" src="/sites/default/files/inline-images/blue-circle.jpg" width="20" loading="lazy"> ) and details ( <img alt="orange icon representing detailed an-events" data-entity-type="file" data-entity-uuid="431f0cb7-83ca-40cd-aa2e-09f998d99206" height="22" src="/sites/default/files/inline-images/orange-circle.jpg" width="21" loading="lazy"> ) for the RADx® Tech program. </p>
|
||
<div class="timeline">
|
||
<div class="an-event year-2020 right"> </div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>April 2020</h2>
|
||
<p>RADx® initiative launches</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 24, 2020</h2>
|
||
<p>P.L. 116-139 Paycheck Protection Program and Health Care Enhancement Act is signed into law; provides funding for RADx initiative</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 29, 2020</h2>
|
||
<p>RADx® initiative launches</p>
|
||
<p><a href="/news-events/newsroom/nih-mobilizes-national-innovation-initiative-covid-19-diagnostics">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue left">
|
||
<div class="content blue">
|
||
<h2>May-June 2020</h2>
|
||
<p>Projects submitted and review process begins; 400 proposals were started in the first 24 hours</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">July 22, 2020</h2>
|
||
<p>RADx® initiative leadership publishes <a href="https://www.nejm.org/doi/full/10.1056/NEJMsr2022263">NEJM article</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">July 31, 2020</h2>
|
||
<p>$248.7 million awarded for seven Phase 2 contracts for POC and Lab testing</p>
|
||
<p><a href="/news-events/newsroom/nih-delivering-new-covid-19-testing-technologies-meet-us-demand">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>August 2020</h2>
|
||
<p>A total of 716 applications are submitted</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">August 11, 2020</h2>
|
||
<p>Submission portal closes due to overwhelming response</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>September 2020</h2>
|
||
<p>More than 16 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">September 2, 2020</h2>
|
||
<p>$129.3 million awarded for nine Phase 2 contracts for POC and Lab testing</p>
|
||
<p><a href="/news-events/newsroom/nih-continues-boost-national-covid-19-testing-capacity">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>October 2020</h2>
|
||
<p>More than 19 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 2, 2020</h2>
|
||
<p>Quidel Sofia ITAP support leads to Quidel: Sofia Inc FDA EUA for rapid antigen multiplex test (COVID and flu)</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 6, 2020</h2>
|
||
<p>$98.4 million awarded for six Phase 2 contracts for POC and Lab testing</p>
|
||
<p><a href="/news-events/newsroom/nih-radx-initiative-advances-six-new-covid-19-testing-technologies">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 15, 2020</h2>
|
||
<p>Sonic receives FDA EUA for multiplex assay of COVID-19 and influenza</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 22, 2020</h2>
|
||
<p>Helix OpCo receives FDA EUA for lab-based test and sequencing test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 28, 2020</h2>
|
||
<p>Illumina receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>November 2020</h2>
|
||
<p>More than 21 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">November 6, 2020</h2>
|
||
<p>UCLA Octant receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>December 2020</h2>
|
||
<p>More than 24 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">December 7, 2020</h2>
|
||
<p>Luminostics, Inc. receives FDA EUA for POC test</p>
|
||
<p><a href="https://whentotest.org/">When to Test website launches</a></p>
|
||
<p><a href="/news-events/newsroom/nih-funded-tool-helps-organizations-plan-covid-19-testing">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">December 15, 2020</h2>
|
||
<ul>
|
||
<li>Ellume is the first over-the-counter (OTC) home test to receive FDA EUA | <a href="/news-events/newsroom/nih-funded-covid-19-home-test-first-receive-over-counter-authorization-fda">Press Release</a></li>
|
||
<li>Mesa enters agreement with NBA to test players, staff and coaches</li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">December 17, 2020</h2>
|
||
<p>MatMaCorp receives FDA EUA for POC test - EUA revoked Aug. 3, 2021</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">December 22, 2020</h2>
|
||
<p>Quidel receives FDA EUA for QuickVue POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event year-2021 right"> </div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>January 2021</h2>
|
||
<p>More than 34 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">January 5, 2021</h2>
|
||
<p>Illumina and Helix collaborate with CDC to develop national surveillance infrastructure for COVID-19 variants</p>
|
||
<p>Quanterix receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">January 7, 2021</h2>
|
||
<p>Mesa Biotech, Inc. receives FDA EUA for POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">January 21, 2021</h2>
|
||
<p>$36.7 million awarded for three Phase 2 contracts for POC testing and Lab Products</p>
|
||
<p><a href="/news-events/newsroom/nih%E2%80%99s-radx-tech-program-inks-additional-contracts-covid-19-diagnostic-tests-and-supplies">Announcement</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>February 2021</h2>
|
||
<p>More than 51 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">February 2021</h2>
|
||
<ul>
|
||
<li>DOD awards Ellume $231.8 million contract to increase test production</li>
|
||
<li>Study to evaluate at-home testing using the My Data Helps app launches</li>
|
||
<li>Aegis announces expansion of diagnostic testing with Walgreens at more than 3,000 locations</li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">February 8, 2021</h2>
|
||
<p>ITAP support leads to Visby Medical FDA for POC multiplex test (COVID-19 and flu)</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">February 26, 2021</h2>
|
||
<p>Fluidigm Corp., Inc. receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>March 2021</h2>
|
||
<p>More than 65 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">March 1, 2021</h2>
|
||
<p>Quidel QuickVue at-home test with prescription receives FDA EUA, will be used to evaluate at-home testing app</p>
|
||
<p><a href="/news-events/newsroom/nih-evaluate-covid-19-home-testing-system">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">March 5, 2021</h2>
|
||
<p>Implementation guide and K-12 playbook added to the <a href="https://whentotest.org/">When to Test </a>website</p>
|
||
<p>Broad Institute receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">March 23, 2021</h2>
|
||
<p>$29.3 million awarded for four Phase 2 contracts for POC and Lab testing</p>
|
||
<p><a href="/news-events/newsroom/radx-diversifies-covid-19-test-portfolio-four-new-contracts-including-one-detect-variants">Announcement</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">March 24, 2021</h2>
|
||
<p>Becton, Dickenson, and Co. receives FDA EUA for POC multiplex test(COVID and Flu)</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">March 31, 2021</h2>
|
||
<p>NIH-CDC self-testing intervention launches</p>
|
||
<p><a href="/news-events/newsroom/cdc-and-nih-bring-covid-19-self-testing-residents-two-locales">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>April 2021</h2>
|
||
<p>More than 71 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 13, 2021</h2>
|
||
<p>Qorvo receives FDA EUA for POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 15, 2021</h2>
|
||
<p>PathGroup receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 20, 2021</h2>
|
||
<p>PathogenDx receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 23, 2021</h2>
|
||
<p>$65 million awarded for four Phase 2 contracts for POC, home testing, and wastewater surveillance</p>
|
||
<p><a href="/news-events/newsroom/radx-expands-covid-19-home-and-point-care-testing-wastewater-surveillance">Announcement</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 29, 2021</h2>
|
||
<p>RADx® initiative is one-year old</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>May 2021</h2>
|
||
<p>More than 105 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">May 19, 2021</h2>
|
||
<p>$3 million award for one Phase 2 contract for POC and home test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>June 2021</h2>
|
||
<p>More than 120 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">June 7, 2021</h2>
|
||
<p>RADx® Tech II solicitation opens. Closed on June 28, 2021.</p>
|
||
<p>A total of 100 applications were submitted.</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>July 2021</h2>
|
||
<p>More than 146 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">July 8, 2021</h2>
|
||
<p>Ellume receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">July 16, 2021</h2>
|
||
<p>GenBody, Inc. receives FDA EUA for OTC antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>August 2021</h2>
|
||
<p>More than 151 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">August 24, 2021</h2>
|
||
<p>Becton, Dickinson and Co. receives FDA EUA for OTC antigen test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Sept. 2021</h2>
|
||
<p>More than 164 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Sept. 1, 2021</h2>
|
||
<p>$13 million award for one Phase 2 contract for lab-based test to detect variants</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">September 24, 2021</h2>
|
||
<p>ANP Technologies receives FDA EUA for POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Oct. 2021</h2>
|
||
<p>More than 164 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange-lg right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 14, 2021</h2>
|
||
<p>$77.7 million awarded for 12 Phase 2 contracts for new types of home and POC testing</p>
|
||
<p><a href="/news-events/newsroom/nih-radx-initiative-expands-covid-19-testing-innovation-additional-types-rapid-tests">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 21, 2021</h2>
|
||
<p>Xtrava, Inc. receives FDA EUA for POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 27, 2021</h2>
|
||
<p>Announcement of the Independent Test Assessment Program (ITAP)</p>
|
||
<p><a href="/news-events/newsroom/new-hhs-actions-add-biden-administration-efforts-increase-access-easy-use-over-counter-covid-19-tests">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">October 28, 2021</h2>
|
||
<p>Detect, Inc. receives FDA EUA for POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Nov. 2021</h2>
|
||
<p>More than 181 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">November 5, 2021</h2>
|
||
<p>Tails Biomedical receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">November 9, 2021</h2>
|
||
<p>Meridian Biosciences receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Dec. 2021</h2>
|
||
<p>More than 189 million tests produced this month</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">December 29, 2021</h2>
|
||
<p>ITAP support leads to Siemens and Roche FDA EUA for rapid OTC tests</p>
|
||
<p><a href="/news-events/newsroom/two-new-over-counter-home-covid-19-tests-brought-us-market-quickly-biden-harris-administration">Press Release</a></p>
|
||
</div>
|
||
</div>
|
||
<!-- section to check --><div class="an-event year-2022 right"> </div>
|
||
<!-- / section to check --><div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Jan. 2022</h2>
|
||
<p>More than 220 million tests produced this month, of these 45 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">January 19, 2022</h2>
|
||
<p>ITAP support leads to Maxim Biomedical FDA EUA for rapid OTC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">January 21, 2022</h2>
|
||
<p>Mammoth Biosciences receives FDA EUA for lab-based test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Feb. 2022</h2>
|
||
<p>More than 283 million tests produced this month, of these 111 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">February 8, 2021</h2>
|
||
<p>Uh-Oh Labs receives FDA EUA for POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>March 2022</h2>
|
||
<p>More than 280 million tests produced this month, of these 128 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">March 15, 2022</h2>
|
||
<p>Minute Molecular receives FDA EUA for POC test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>April 2022</h2>
|
||
<p>More than 522 million tests produced this month, of these 342 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 6, 2022</h2>
|
||
<p>ITAP support leads to OSANG, LLC and Xiamen Boson Biotech Co., Ltd. FDA EUA for rapid OTC tests</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 11, 2022</h2>
|
||
<p>Detect receives FDA EUA for OTC molecular test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 14, 2022</h2>
|
||
<p>MicroGem US, Inc. receives FDA EUA for POC molecular test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>May 2022</h2>
|
||
<p>More than 500 million tests produced this month, of these 331 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">May 3, 2022</h2>
|
||
<p>Mobile Applications Reporting through Standards (MARS) program begins collecting results of at-home tests from manufacturers. <a href="/covid-19/radx-tech-program/mars">MARS program</a> information.</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>June 2022</h2>
|
||
<p>More than 531 million tests produced this month, of these 350 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>July 2022</h2>
|
||
<p>More than 528 million tests produced this month, of these 349 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">July 8, 2022</h2>
|
||
<p>ITAP support leads to FDA EUA for Watmind, USA for OTC molecular test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>August 2022</h2>
|
||
<p>More than 524 million tests produced this month, of these 349 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Sept 2022</h2>
|
||
<p>More than 482 million tests produced this month, of these 310 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Sept. 8, 2022</h2>
|
||
<p>Announcement of <a href="/news-events/newsroom/nih-seeks-next-generation-covid-19-diagnostics">Tech III solicitations</a>. Application period is Sept. 20 - Oct. 31 (NEW deadline)</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Oct 2022</h2>
|
||
<p>More than 470 million tests produced this month, of these 299 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Nov 2022</h2>
|
||
<p>More than 450 million tests produced this month, of these 299 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Nov 17, 2022</h2>
|
||
<p>ANP Technologies receives FDA EUA for OTC antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Nov 21, 2022</h2>
|
||
<p>ITAP support leads to Azure Biotech, Inc. FDA EUA for rapid OTC pen test</p>
|
||
<p>CorDx, Inc. receives FDA EUA for OTC, rapid antigen test </p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Nov 22, 2022</h2>
|
||
<p>Launch of the Make My Test Count at-home test reporting website</p>
|
||
<p><a href="/news-events/newsroom/nih-establishes-website-self-reporting-covid-19-test-results">Press release</a></p>
|
||
<p>ITAP support leads to Lucira Health Inc. FDA EUA for POC multiplex test (COVID-19 and flu)</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Dec 2022</h2>
|
||
<p>More than 420 million tests produced this month, of these 260 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event year-2023 right"> </div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Jan 2023</h2>
|
||
<p>More than 431 million tests produced this month, of these 260 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Jan 5, 2023</h2>
|
||
<p>Launch of Home Test to Treat program</p>
|
||
<p><a href="/news-events/newsroom/nih-launches-home-test-treat-pilot-covid-19-telehealth-program">Press release</a></p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>Feb 2023</h2>
|
||
<p>More than 430 million tests produced this month, of these 260 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">February 8, 2023</h2>
|
||
<p>ADL Diagnostics (formerly Anavasi Diagnostics) received FDA EUA for POC molecular test</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Feb 17, 2023</h2>
|
||
<p>GenBody, Inc. receives FDA EUA for OTC rapid, antigen test; supported by RADx Tech and ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Feb 22, 2023</h2>
|
||
<p>Mologic, Inc. receives FDA EUA for OTC antigen test; supported by RADx Tech and ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>March 2023</h2>
|
||
<p>More than 230 million tests produced this month, of these 100 million are ITAP-supported</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>April 2023</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 14, 2023</h2>
|
||
<p>Azure Biotech, Inc. receives FDA EUA for OTC rapid, antigen test; supported by ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 24, 2023</h2>
|
||
<p>ITAP support leads to Princeton Biomeditech FDA EUA for OTC antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>June 2023</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">June 15, 2023</h2>
|
||
<p>Lucira by Pfizer, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B molecular test; supported by RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>August 2023</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">August 16, 2023</h2>
|
||
<p>Visby Medical, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B molecular test; supported by RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event year-2024 right"> </div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>February 2024</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">February 29, 2024</h2>
|
||
<p>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</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>March 2024</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">March 21, 2024</h2>
|
||
<p>CorDx, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
<p>OSANG, LLC receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>April 2024</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 3, 2024</h2>
|
||
<p>OSANG, LLC receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 5, 2024</h2>
|
||
<p>CorDx, Inc. receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 19, 2024</h2>
|
||
<p>Wondfo USA Co., Ltd. receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">April 30, 2024</h2>
|
||
<p>Wondfo USA Co., Ltd. receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>May 2024</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">May 7, 2024</h2>
|
||
<p>iHealth Labs, Inc. receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">May 8, 2024</h2>
|
||
<p>Watmind USA receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">May 24, 2024</h2>
|
||
<p>Watmind USA receives FDA EUA for OTC multiplex COVID-19 and Flu A/B antigen test; supported by RADx Tech and RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">May 31, 2024</h2>
|
||
<p>iHealth Labs, Inc. receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>June 2024</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">June 10, 2024</h2>
|
||
<p>Healgen Scientific, LLC receives FDA EUA for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
<div class="an-event blue-lg left">
|
||
<div class="content blue">
|
||
<h2>October 2024</h2>
|
||
</div>
|
||
</div>
|
||
<div class="an-event orange right">
|
||
<div class="content orange">
|
||
<h2 class="orange">Oct 7, 2024</h2>
|
||
<p>Healgen Scientific, LLC receives FDA de novo authorization for POC multiplex COVID-19 and Flu A/B antigen test; supported by RADx ITAP</p>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<p class="text-align-center"><em><strong>More updates to come as the RADx® Tech program continues.</strong></em></p>
|
||
<p class="text-align-center">Note, the number of tests produced per month will no longer be updated as of March 2023.</p>
|
||
</div>
|
||
|
||
|
||
</div>
|
||
</article>
|
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