SINGAPORE—In late March, Vela Diagnostics, with global headquarters in Singapore and regional ones in the United States and Germany, announced that it had developed the ViroKey SARS-CoV-2 RT-PCR Test, a new diagnostic test for the detection of SARS-CoV-2, the virus that causes COVID-19.
At the time, Vela Diagnostics was in discussions with the U.S. Food and Drug Administration (FDA) for authorization of the test under the emergency use authorization (EUA). The EUA would allow the emergency use of FDA medical products in qualified labs, thereby facilitating widespread access to the diagnostic test. Target customers include reference labs and CLIA labs.
Vela Diagnostics was expecting CE-IVD approval for the ViroKey SARS-CoV-2 RT-PCR Test in Europe by the end of March (though as of April 1 there was no official announcement from the company that this had yet occurred), with a planned FDA EUA submission in April.
On March 30, Vela announced that ahead of the EUA—and in accordance with the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency guidance document issued on March 16—Vela would offer the manual ViroKey SARS-CoV-2 RT-PCR Test when validation is completed. Validation is targeted to be completed by early April 2020. After validating the test, Vela Diagnostics says it will offer the assay immediately in accordance with Section IV.C. of FDA’s mid-March policy release.
Vela noted at the end of March that it was currently working with the FDA for authorization of the manual test under the Feb. 4, 2020 existing public health emergency authorizing EUA of in-vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19.
The ViroKey SARS-CoV-2 RT-PCR Test detects and differentiates the SARS-CoV-2 from other respiratory pathogens such as influenza. The manual assay was developed to facilitate quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instruments. The research use only test is configured for an automated workflow consisting of the Sentosa SX101 instrument, in conjunction with the ABI 7500 Fast Dx or the Sentosa SA201 instruments.
Using Reverse Transcription PCR (RT-PCR), the ViroKey SARS-CoV-2 RT-PCR Test specifically detects the gene targets ORF1a and RdRp in SARS-CoV-2 RNA from nasopharyngeal and oropharyngeal swabs. The test is used on the automated VELA PCR Workflow. The PCR Workflow provides high-throughput processing and reportedly delivers clinically relevant results with reduced hands-on (0.5 hours) and turnaround time ( about 3.5 hours) for 48 samples (46 samples plus 1 positive control plus 1 negative control).
Concurrent with the ViroKey effort, Vela Diagnostics and Great Basin Scientific are also co-developing a SARS-CoV-2 assay for use on Great Basin’s sample-to-result diagnostic system. The Great Basin system utilizes a disposable cartridge with fully integrated reagents and internal controls. The Great Basin automated bench-top analyzer performs all steps in the assay, visually interprets the results, and provides a digital report of the results. Great Basin is targeting to deliver a diagnostic result in under 90 minutes for the SARS-CoV-2 assay.