The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced that two tests to detect the COVID-19 coronavirus are in development.
The tests would be able to produce results in approximately one hour.
The Biomedical Advanced Research and Development Authority (BARDA) within ASPR will award about $679,000 to DiaSorin Molecular of Cypress, Calif., to develop the Simplexa COVID-19 Direct Assay.
Also, BARDA awarded approximately $598,000 to QIAGEN of Germantown, Md., to accelerate the development of the QIAstat-Dx RPS2 test for COVID-19.
“Americans need access to rapid diagnostic testing. The sooner clinicians, patients, and public health officials know whether someone is infected with the novel coronavirus, the sooner they can take action to mitigate the spread of COVID-19,” BARDA Director Rick Bright said. “Rapid diagnostic tests are critical in this public health response. We are working with the private sector at an urgent pace to make these tests available on as many diagnostic platforms as we can in the coming weeks.”
DiaSorin Molecular’s COVID-19 test could potentially be ready within six weeks for Emergency Use Authorization (EUA) consideration by the U.S. Food and Drug Administration (FDA).
QIAGEN will develop a COVID-19 test, called the QIAstat-Dx RPS2, to run FDA-cleared tests for 21 respiratory pathogens. The COVID-19 test could be ready within 12 weeks for consideration by the FDA. Currently, there are no approved diagnostics, vaccines, or treatments for COVID-19.
Also, HHS Secretary Alex Azar named Admiral Brett Giroir, M.D., as the assistant secretary for health and head of the Public Health Service. Giroir will be responsible for coordinating COVID-19 diagnostic testing efforts among Public Health Service agencies, including the Centers for Disease Control and Prevention and the Food and Drug Administration, as well as state and local public health authorities and private or public clinical laboratories.
“Like all of our public health leaders at HHS, Dr. Giroir has been helping with our response to COVID-19 from the start. Dr. Giroir has worked closely with CDC and FDA to coordinate numerous complex public health efforts in his time at HHS,” Azar said. “As the outbreak evolves, he is ideally situated to help ensure that any American who needs a test for COVID-19 can receive it. A key priority is to ensure that patients, doctors, and hospitals can access tests seamlessly and with maximum ease, and Dr. Giroir will lead efforts to execute on that goal.”
Giroir previously served as acting commissioner of Food and Drugs and as senior advisor to the HHS secretary on matters involving the CDC.