NEW YORK – DiaSorin Molecular announced on Friday that it has been awarded funding to develop an assay for the SARS-CoV-2 virus that causes the disease COVID-19. The award totals $679,000 and will enable the firm to rapidly develop its coronavirus test, called the Simplexa COVID-19 Direct Assay.
The funding is being provided through a streamlined process called an easy broad agency announcement (EZ-BAA), which is managed by the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response's (ASPR's) Biomedical Advanced Research and Development Authority (BARDA).
BARDA launched the EZ-BAA process to support commercial coronavirus diagnostic test development last month, with the first funding — awards to Hologic and Qiagen — announced this week.
The DiaSorin test will use nasopharyngeal swabs from patients and is being designed for use with the company's Simplexa Direct technology, a US Food and Drug Administration-cleared platform used for influenza and respiratory syncytial virus testing.
The SARS-CoV-2 test would run on DiaSorin’s Liason MDX instrument, which works in conjunction with Liason MDX Studio software. It uses a sample-to-answer approach with minimal operator input, and HHS noted in a statement that "hundreds of the company's diagnostic devices are in use in large commercial and hospital laboratories around the country."
The test could potentially be ready within six weeks for Emergency Use Authorization (EUA) consideration, according to the statement.
"Americans need access to rapid diagnostic testing," Rick Bright, director of BARDA, said in a statement. "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.
"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," he added.