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Illumina bags FDA Emergency Use Authorization for COVIDSeq™ Test

Author : Pankaj Singh | Published Date : 2020-06-10 

Illumina, Inc., an American biotechnology firm that focuses on genetic variation analysis, has been making developments in large-scale next-generation sequencing (NGS) based COVID-19 testing. The company recently attained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its COVIDSeq™ Test.

COVIDSeq™ test is a sequencing-based, high-throughput, in vitro diagnostic (IVD) kit that enables the identification of SARS-CoV-2. Its end-to-end workflow gives an option to labs to scale their diagnostic testing.

As per reports, COVIDSeq utilizes upper respiratory specimens like oropharyngeal swab or a nasopharyngeal, and offers sample receipt to get results within a day with the help of the NovaSeq™ 6000 Sequencing System. The diagnostic design consists of 98 amplicons that mark the entire SARS-CoV-2 genome, producing high sensitivity and accurate detection.

Currently, COVIDSeq is available at a limited number of early access websites and is anticipated to be fully available by the end of summer.

Speaking on the move, Francis DeSouza, Chief Executive Officer, Illumina, said that the COVIDSeq utilizes the NGS performance to address the global demand for diagnostic testing to combat the COVID-19 crisis. Apart from diagnostic testing, the company and a number of its consumers are exploring the idea of NGS-based workflows to run high-volume screening that would help people return to work soon.

However, COVIDSeq has not been approved by the FDA yet. As of now, it has been authorized by the FDA as per the EUA norms until the span of the declaration that circumstances exist extenuating the sanction of emergency use of IVD for identification or diagnosis of COVID-19.

At this point in time, COVIDSeq is authorized for only U.S. laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to conduct high and moderate complexity tests.

Source Credit: https://www.businesswire.com/news/home/20200609005872/en/Illumina-Receives-FDA-Emergency-Authorization-Sequencing-Based-COVID-19

About Author

Pankaj Singh

Pankaj Singh

Endowed with a post graduate degree in management and finance, Pankaj Singh has been a part of the online content domain for quite a while. Having worked previously as a U.K. insurance underwriter for two years, he now writes articles for fractovia.org and other online portals. He can be contacted at- [email protected] | https://twitter.com/PankajSingh2605

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