Singapore, August 26 2020– Vela Diagnostics announced today that the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has been approved by the Australian Therapeutic Goods Administration (TGA) for in vitro diagnostic use.
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is a reverse transcription-polymerase chain reaction (RT-PCR) test that detects SARS-CoV-2 by targeting conserved regions on the SARS-CoV-2 genome, specifically the ORF1a and N genes. The automated test is optimized for a workflow consisting of the Sentosa™ SX101 instrument and works in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx. The workflow tests up to 46 samples in a single run, with minimal hands-on time required.
“This timely approval from the TGA for our automated test will allow Vela Diagnostics to facilitate efficient testing for suspected COVID-19 patients in Australia,” said Sam Dajani, acting CEO and Chairman of the Board.
To date, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has received the CE mark for Europe and the provisional authorization from the Singapore Health Sciences Authority.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.