Illumina has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its sequencing-based Covid-19 diagnostic test.

Illumina COVIDSeq test is a high-throughput, sequencing-based and in vitro diagnostic (IVD) workflow test that facilitates the detection of SARS-CoV-2.

The sequencing-based diagnostic test uses upper respiratory specimens

The sequencing-based diagnostic test, which uses upper respiratory specimens such as nasopharyngeal or oropharyngeal swab, offers sample receipt to result in 24 hours using the NovaSeq 6000 sequencing system.

The differentiated diagnostic design is comprised of 98 amplicons, which target the full SARS-CoV-2 genome, enabling to create precise detection and high sensitivity.

Illumina is currently offering COVIDSeq test to a limited number of early access sites, and plans to increase the supply by summer.

The workflow holds the capacity to accommodate up to 3,072 samples per NovaSeq run through leveraging the S4 flow cell.

It is comprised of steps for viral RNA extraction, RNA-to-CDNA conversion, PCR, library preparation, sequencing and report generation.

The major components leveraged comprise of NovaSeq 6000 along with Illumina Tagmentation library preparation technology and the DRAGEN COVIDSeq test pipeline for rapid reporting.

Illumina CEO Francis deSouza said: “COVIDSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the Covid-19 pandemic.

“Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school.”

In January this year, Illumina and Pacific Biosciences of California have jointly agreed to terminate their previously announced merger deal.

Under the proposed agreement, which was signed in November 2018, Illumina would acquire Pacific Biosciences at an enterprise value of approximately $1.2bn in cash.