BARDA and Vela Diagnostics USA, Inc. are entering into a partnership to develop a rapid diagnostic test for use on two instrument platforms to aid in the detection of COVID-19 infections. Diagnostics on multiple platforms are needed to test as many people as possible and identify those who are infected in order to slow the pandemic.
The company 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 for effective patient management. The ViroKey™ SARS-CoV-2 RT-PCR Test can be done using a manual workflow or by using an automated workflow. Manually, 16 samples can be run in approximately three hours, and 46 samples can be run in three hours using an automated workflow with the Sentosa® SX101 liquid handler followed by amplification and detection on either the ABI 7500 Fast Dx or Sentosa® SA201 Real-Time PCR instrument.
The company will develop the manual workflow test first and shortly thereafter will develop the automated workflow. Upon successful development, the company will seek Emergency Use Authorizations (EUAs) from the FDA for both the manual and automated tests.
BARDA will contribute approximately $224,000, and Vela will fund the remaining development costs.
This award is one component of BARDA’s Rapidly-Expanding COVID-19 Medical countermeasure portfolio, visit BARDA’s COVID-19 Portfolio to learn more.
About the Company:
The following information has been provided by the company and does not indicate an endorsement by the U.S. government of the company or its products.
Vela Diagnostics USA, Inc. was established in 2011 and currently has approximately 200 employees worldwide. The company is a pioneer in offering real-time PCR and Next-Generation sequencing on an integrated platform. Vela Diagnostics USA, Inc. has a global network with direct operations and distributions across North America, Europe, and Asia Pacific. Certified R&D facilities are located in Singapore and United States with manufacturing facilities located in Singapore.