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Illumina receives first FDA emergency use authorization for a sequencing based COVID-19 diagnostic test

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Fifty-eight days ago, we had an idea: create the first sequencing-based COVID-19 diagnostic test for the detection of SARS-Cov-2 in symptomatic individuals. Faster than fast – even by Illumina standards – we assembled a cross-functional team of more than 300 employees, comprising experts from Research & Technology Development, Product Development, Global Quality & Operations, Medical, Marketing and Commercial. Together, the teams worked tirelessly to deliver a powerful NGS solution that targets the full SARS-CoV-2 genome, creating accurate detection and high sensitivity.

Today, less than two months later, Illumina received the first FDA Emergency Use Authorization (EUA) for the Illumina COVIDSeq Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The end-to-end workflow extends the options available for labs to scale diagnostic testing.

Beyond merely detecting the presence of viral RNA, NGS – with our rapid DRAGEN analysis pipelines – provides a detailed view of the viral genome itself, enabling valuable insights into viral function and biology. The ability to generate and share, for example in GISAID, near-complete sequence data of viral genomes allows for collaborative global implementation of effective viral surveillance strategies to prevent further transmission and infection. With this EUA grant, we take an important step toward fighting COVID-19. I want to thank everyone who worked quickly, collaboratively, and skillfully to bring this test to fruition.