The Biomedical Advanced Research and Development Authority (BARDA) is working with Vela Diagnostics USA to develop a rapid diagnostic test for the COVID-19 pandemic.
The rapid diagnostic test would be for use on two instrument platforms, which is needed to test as many people as possible and identify those who are infected to slow the pandemic. Vela will develop two tests, both of which would allow rapid analysis and early detection of SARS-CoV-2 in upper respiratory tract specimens from symptomatic individuals.
The ViroKey SARS-CoV-2 RT-PCR Test can be applied using a manual workflow or by using an automated workflow. Using an automated workflow, 46 samples can be run in three hours. Manually, 16 samples can be run in approximately three hours. The company will develop the manual workflow test first and, shortly after that, will develop the automated workflow.
BARDA, which is part of the U.S. Department of Health and Human Services (HHS), will contribute approximately $224,000 to the project with Vela funding the rest. This award is part of BARDA’s Rapidly-Expanding COVID-19 Medical countermeasure portfolio.
After the tests are ready, Vela will seek Emergency Use Authorizations (EUAs) from the U.S. Food and Drug Administration for both the manual and automated tests.
Vela Diagnostics USA offers real-time PCR and Next-Generation sequencing on an integrated platform. The company has operations and distributions across North America, Europe, and Asia Pacific with R&D facilities in Singapore and the United States and manufacturing facilities in Singapore.