BARDA announces the 64th FDA Approval/Licensure/Clearance for Simplexa™ COVID-19 Direct, the second standalone FDA cleared COVID-19 diagnostic test and supported by BARDA under Novel Public Private Partnerships


WEB ANNOUNCEMENT
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Over the last 15 years since BARDA was established, our team of diagnostic advanced development experts have collaborated with more than 500 industry partners to support the development and manufacturing of a diverse portfolio of medical countermeasures needed to address national security and public health threats.

From investing in early innovation, to late-stage product development through U.S. Food and Drug Administration (FDA) approval, BARDA focuses on the end goal with each partnership: ensuring products are available for the American people and the global community to protect health and save lives from a national security threat or other public health emergency. FDA approval, licensure, and clearance for medical countermeasures is a critical milestone for our partners and for BARDA and demonstrates the success of public-private partnerships in mitigating threats and creating a return on the public investment. That’s why we celebrate every FDA approval, licensure, or clearance of a medical countermeasure.

At BARDA, we are excited about the news of the recent FDA clearance of a COVID-19 molecular diagnostic test, Simplexa™ COVID-19 Direct, from our partner DiaSorin Molecular LLC. The Simplexa™ COVID-19 Direct test is a real-time RT-PCR system that enables the direct amplification and detection of SARS-CoV-2 (the virus that causes COVID-19) RNA from nasopharyngeal or nasal swab specimens without the need for nucleic acid extraction. BARDA and DiaSorin Molecular LLC partnered in March 2020 to develop, validate, and obtain Emergency Use Authorization (EUA) and FDA clearance for a molecular test to detect SARS-CoV-2 virus. The success of the program demonstrates the integrated government-industry effort to drive medical countermeasures from bench to bedside.

The Simplexa™ COVID-19 Direct is:

  • An easy to use, sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens in a laboratory setting. The test provides results in about an hour.
  • Designed for use on the LIAISON MDX platform with the direct amplification disc (DAD) the development of which was funded by BARDA 13 years ago as part of our Influenza preparedness efforts.
  • Highly specific for SARS-CoV-2, targeting two regions of the viral genome to minimize the impact of SARS-CoV-2 mutations on test performance.

From the initial assay development to the ultimate 2022 FDA clearance of the Simplexa™ COVID-19 Direct test, we are honored to be a part of this endeavor which helps make the world a healthier, safer place. For us, number 64 illustrates what government and industry can accomplish together. With novel medicines, diagnostics, and vaccines we can save lives, protect the American people and enhance global health security.

Visit our FDA Approval Page to learn more about our support aiding our partners in achieving the other 63 approvals. While obtaining FDA approval, licensure, and clearance is a major milestone and symbol of development success, regulatory approval is not the end game for those of us in public health preparedness and response. Making sure those products are available when they’re needed is the real end game. Each approval offers an opportunity to recognize the collective and collaborative work of the scientific community, government partners, and our industry partners to enhance national health security. Approval number 64 highlights just that, 15 years of public and private partnerships to counter health security threats.

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...AND WE HAVE MORE IN THE PIPELINE

Explore BARDA's CBRN and COVID-19 medical countermeasure portfolio to learn about other exciting products in the pipeline.

 

Last Updated: September 22, 2022

COVID-19 Medical Countermeasure Portfolio

This award is one component of BARDA's expanding COVID-19 medical countermeasure portfolio; visit BARDA's COVID-19 Portfolio to learn more.