DiaSorin Molecular, Cypress, Calif, has received federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, in order to develop a molecular test for qualitative identification of the novel coronavirus SARS-CoV-2, which causes COVID-19 disease, in response to the evolving global health emergency.
The product is expected to be CE marked and submitted to the FDA by the end of March 2020 to consider for emergency use authorization. The test is designed for use on any of the company’s Liaison Mdx instruments, hundreds of which are currently placed in hospital laboratories around the United States. The test will utilize DiaSorin’s direct amplification disc technology, enabling fast, sample-to-answer results. The rapid turnaround time will allow for prompt decisionmaking in patient management, which is critical to help hospitals contain the current outbreak and guide treatments. DiaSorin Molecular’s PCR test will also target several regions of the viral genome to minimize the effects of possible future mutations.
“We are excited to receive this funding and continue with the development of our test,” says Michelle Tabb, PhD, chief scientific officer at DiaSorin Molecular. “As soon as the sequence information was made available we immediately began working. We have analyzed over 175 viral sequences published in the GeneBank database to develop a test that detects all known isolates of the SARS-CoV-2 virus to ensure laboratories can be confident in the test results.”
“The coronavirus outbreak has sparked global alarm and created intense pressure on healthcare systems to provide laboratory testing that detects the new strain of virus,” says John Gerace, president of DiaSorin Molecular. “It is important to have a coronavirus test that provides accurate results in a timely fashion and enables clinicians to make appropriate diagnostic decisions. As a specialty diagnostics company, we have a duty to respond with urgency by mobilizing our R&D team to develop a molecular solution. It is our hope that our test may help to contain this new outbreak.”
For more information, visit DiaSorin Molecular.