Vela Diagnostics has secured CE mark approval for the manual version of the ViroKey SARS-CoV-2 RT-PCR test for in vitro diagnostic applications.
The test will help identify the SARS-CoV-2 in patients suspected of COVID-19 by their healthcare providers.
The ViroKey SARS-CoV-2 RT-PCR test is a probe-based reverse transcription PCR Test that targets conserved regions of the SARS-CoV-2 genome to detect SARS-CoV-2.
The manual version of the assay allows the rapid adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments.
Vela Diagnostics acting CEO and board chairman said: “The CE mark enables Vela Diagnostics to expand COVID-19 testing capacity in Europe, where there is an urgent need to identify individuals infected with SARS-CoV-2.”
Vela Diagnostics also developed automated version of the test
The company has also developed an automated version of the test, which is expected to be filed for CE-IVD registration in April this year.
The automated ViroKey SARS-CoV-2 RT-PCR test has been enhanced for a workflow that includes Sentosa SX101 instrument in association with the Sentosa SA201 instrument or the ABI 7500 Fast Dx.
In January this year, Vela Diagnostics secured FDA authorisation to market its Sentosa SQ HIV-1 Genotyping Assay for the detection of HIV-1 genomic drug resistance mutations (DRMs).
Using the plasma of patients infected with HIV-1, the company’s in-vitro diagnostic test detects HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test.
Vela Diagnostics offers an automated IVD next–generation sequencing (NGS) workflow for the customers in the global diagnostics market.
An integrated Sentosa platform is used to apply the company’s real-time PCR and NGS applications.
