NEW YORK – Vela Diagnostics said on Thursday it has received provisional authorization from Singapore's Health Sciences Authority for the firm's ViroKey SARS-CoV-2 RT-PCR Test.
As a result, Vela can offer the test to healthcare institutes, private hospitals, medical clinics, and clinical laboratories licensed in Singapore.
The test is a probe-based reverse transcription PCR test for detecting the coronavirus by targeting conserved regions of its genome, the firm said, adding the manual version of the assay can be adopted by laboratories equipped with Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx platforms. Vela has also developed a research-use-only automated version of the test for high-throughput testing. The RUO assay is optimized for use with the Sentosa SX101 instrument, Sentosa SA201 instrument, and Applied Biosytems 7500 Fast Dx.
The test is awaiting CE marking, Vela said.