Vela Diagnostics Awarded BARDA Contract to Develop Manual and Automated COVID-19 Tests

Under the agreement, Vela Diagnostics will perform verification and clinical validation of the ViroKey SARS-CoV-2 RT-PCR Test to be used on automated and manual workflows for Emergency Use Authorization (EUA) submission to the US Food and Drug Administration (FDA).

The ViroKey SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome. The automated ViroKey SARS-CoV-2 RT-PCR Test is performed on a workflow consisting of the Sentosa SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument or the Sentosa SA201 instrument. Up to 48 samples (including positive and negative controls) can be processed per run on the automated workflow. The manual assay was developed to enable flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments.

"High throughput detection of SARS-CoV-2 using our automated workflow will provide rapid and valuable information to save lives," said Sam Dajani, acting CEO and chairman of the Board. "The funding from BARDA will enable Vela Diagnostics to increase the domestic and global testing capacity for COVID-19 to curb further spread of the virus."

"Rapid diagnostic tests put essential information into the hands of healthcare providers and patients to manage patient care safely and appropriately. Data gathered from high-throughput testing aids public health officials in making decisions about community mitigation to combat the pandemic," said BARDA Director Rick Bright, Ph.D.

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