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Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization

Singapore, February 11, 2020 – Vela Diagnostics has developed the ViroKeyTM SA201 COVID-19 RT-PCR Test, a new diagnostic test for the detection of the COVID-19 coronavirus. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration (FDA) for clearance of the test under the emergency use authorization (EUA). The EUA will allow the emergency use of FDA unapproved medical products in qualified labs, thereby facilitating widespread access to the diagnostic test. 

The ViroKeyTM SA201 COVID-19 RT-PCR Test will be officially available by end-February with the facility to pre-order now. 

The COVID-19 coronavirus was first identified in mid-December 2019 in Wuhan, China. Human-to-human transmission has been confirmed by China’s health ministry. According to Chinese health agencies, there are more than 40,000 confirmed cases with at least 900 fatalities in China, while over 200 cases have been confirmed in more than 20 other countries. These numbers are expected to increase. There is an urgent need for a fast, high-throughput and accurate diagnostic method to provide timely treatment for those infected and to prevent the spread of the virus.

 The ViroKeyTM SA201 COVID-19 RT-PCR Test will be able to detect and differentiate the COVID-19 coronavirus from other closely related coronaviruses such as SARS and MERS. To enable high-throughput processing of 96 samples in 4 hours, the test is configured for an automated workflow consisting of the SentosaTM SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument (ABI 7500 Fast Dx) or the SentosaTM SA201. The SentosaTM SA201 platform also supports other tests such as the SentosaTM SA201 HSV-1/2 PCR Test (U.S. FDA cleared) and the SentosaTM SA201 ZIKV RT-PCR Test (for use under Emergency Use Authorization from the U.S. FDA). As time-to-market is critical to address the urgent need for the test, a manual kit will also be made available to facilitate the fast adoption of the test by laboratories with existing ABI 7500 Fast Dx PCR instruments.

Concurrently, Vela Diagnostics and Great Basin Scientific are co-developing a COVID-19 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 COVID-19 assay.

About Vela Diagnostics

Vela Diagnostics is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated SentosaTM platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. All SentosaTM products listed above are by Vela Diagnostics. For more information, visit

About Great Basin Scientific

Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. Great Basin Scientific is dedicated to developing simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. Our vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the company’s website at

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