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2020

Vela Diagnostics to offer manual ViroKey™ SARS-CoV-2 RT-PCR Test after completion of Emergency Use Authorization validation, targeted to be by early April 2020

Singapore, March 30, 2020 – Ahead of Emergency Use Authorization (EUA) and in accordance with the U.S. Food and Drug Administration (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency guidance document issued on March 16, 2020, Vela Diagnostics will 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 will offer the assay immediately in accordance with Section IV.C. of FDA’s policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, dated March 16, 2020.

Vela Diagnostics is currently working with the FDA for authorization of the manual test under the February 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 manual ViroKey™ SARS-CoV-2 RT-PCR Test is also on track to receive CE-IVD approval by the end of March.

In February 2020, Vela Diagnostics announced the development of the ViroKey™ SARS-CoV-2 RT-PCR Test for the detection of SARS-CoV-2, 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 (RUO) 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.

To date, COVID-19 has affected 199 countries and territories around the world, with more than 240 000 cases in US, Europe and China combined and at least 27 000 fatalities worldwide. On 11 March 2020, the World Health Organization declared COVID-19 a pandemic.

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 Sentosa™ 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 Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

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

Singapore, February 11, 2020 (updated on February 21, 2020) – Vela Diagnostics has developed the ViroKey™ SARS-CoV-2 RT-PCR Test, a new diagnostic test for the detection of COVID-19. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration (FDA) for authorization of the test under the emergency use authorization (EUA). The EUA will allow the emergency use of FDA medical products in qualified labs, thereby facilitating widespread access to the diagnostic test.

The ViroKey™  SARS-CoV-2 RT-PCR Test (Research Use Only)(1) will be officially available by end-February with the facility to pre-order now.  (link to product)

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. To date, there have been 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 ViroKey™  SARS-CoV-2 RT-PCR Test (Research Use Only)(1) will be able to detect and differentiate the SARS-CoV-2 from other closely related coronaviruses such as SARS-CoV and MERS-CoV. To enable high-throughput processing of 96 samples in 4 hours, the test is configured for an automated workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument (ABI 7500 Fast Dx) or the Sentosa™ SA201. The Sentosa™ SA201 platform also supports other tests such as the Sentosa™ SA201 HSV-1/2 PCR Test (U.S. FDA cleared) and the previously authorized Sentosa™ 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 2019-nCoV 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 2019-nCoV 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 Sentosa™ 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 Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

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 http://www.gbscience.com.

Note:

(1)       This is to clarify the press release on February 11, 2020.  All references to any pre-order, sale, offer to sell, marketing and distribution of the ViroKey™  SARS-CoV-2 RT-PCR Test refers to the Research Use Only version.

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