Vela Diagnostics is a New Jersey-based company that has created a Covid-19 testing system based on the “gold standard” of PCR amplification. Prior to the outbreak of Covid-19, Vela Diagnostics had established itself as a worldwide supplier of integrated life sciences and diagnostic solutions. The company had already been specializing in PCR technology and Nex-Generation Sequencing. Their philosophy is to focus on easy-to-use, fast, accurate, and cost-effective patient testing solutions.
Vela’s ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 tests for Covid-19 by analyzing nasal and oral swab samples. This approach uses an automated workflow system using the Sentosa™ SX101 instrument, the Sentosa™ SA201 RT-PCR instrument, or the ABI 7500 Fast Dx. This workflow allows for 46 tested samples at a time, two controls per run, and results in about 4.5 hours. The company later released a ViroKey™ Flu A/B & RSV RT-PCR Extension Kit that allows for the differentiation of four virus types, including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2.
In April, Vela Diagnostics was granted an Emergency Use Authorization (EUA) from the FDA for the distribution and large-scale manufacture of its testing kits. In addition, the Australian Therapeutic Goods Administration (TGA) and the Health Sciences Authority in Singapore also granted the company similar authorizations. Vela later received another EUA from the FDA for the second version of its testing kit.