Vela Diagnostics gains EUA for ViroKey™ SARS-CoV-2 RT-PCR test v2.0
Category: #health  By Saipriya Iyer  Date: 2020-09-24
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Vela Diagnostics gains EUA for ViroKey™ SARS-CoV-2 RT-PCR test v2.0

Vela Diagnostics has recently announced that the U.S. FDA has granted an EUA (Emergency Use Authorization) for its ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 in the United States. This automated probe-based reverse transcription polymerase chain reaction test developed by the integrated molecular solutions provider is designed to detect SARS-CoV-2, the virus that causes the COVID-19 disease.

The real-time RT-PCR test has been developed to detect the virus via samples of the oropharyngeal and nasopharyngeal swabs, in order to prevent further outbreak of coronavirus across the globe.

For the record, Vela Diagnostics is a leading company that provides integrated IVD (in-vitro diagnostic) system solutions. The test solutions of Vela utilize its automated Sentosa® platform, offering the unique ability to leverage a system for PCR and NGS testing and detect various infectious and chronic diseases such as cancer. With the Emergency Use Authorization, all the U.S. laboratories that are certified under the CLIA (Clinical Laboratory Improvement Amendments) will be able to use the company’s ViroKey RT-PCR test to detect the virus infection.

As per the statement made by Vela Diagnostics’ CEO & Chairman of the Board, Sam Dajani, the authorization of the company’s automated coronavirus detection kit will enable it to assist healthcare professionals and clinical laboratories in fighting against the deadly coronavirus in the United States.

This COVID-19 detection kit is an automated probed-based RT-PCR test that has been optimized for workflow in healthcare settings. Moreover, this automated test consists of the company’s Sentosa® SA201 and Sentosa® SX101, ensuring high throughput testing of over 46 samples in a single run as well as reducing hands-on time.

In addition to gaining EUA from the U.S. FDA, Vela’s recently announced RT-PCR test also has received the Conformitè Europëenne (CE) mark as well as Provisional Authorization from Singapore HSA (Health Sciences Authority).

Source credit:

https://finance.yahoo.com/news/vela-diagnostics-sars-cov-2-045300270.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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