Illumina Receives First FDA Emergency Use Authorization for a Sequencing-Based COVID-19 Diagnostic Test
June 09 2020 - 10:36PM
Business Wire
Illumina, Inc. (NASDAQ: ILMN) is paving the way for large-scale,
next-generation sequencing-based (NGS) COVID-19 testing. Today, the
U.S. Food and Drug Administration (FDA) issued an 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.
COVIDSeq uses upper respiratory specimens, including a
nasopharyngeal or oropharyngeal swab, and delivers sample receipt
to result in 24 hours using the NovaSeq™ 6000 Sequencing System.
The differentiated diagnostic design includes 98 amplicons that
target the full SARS-CoV-2 genome, creating accurate detection and
high sensitivity. COVIDSeq is currently available to a limited
number of early access sites, and is expected to be more broadly
available this summer.
The workflow accommodates up to 3,072 samples per NovaSeq run
leveraging the S4 flow cell, and includes steps for viral RNA
extraction, RNA-to-CDNA conversion, PCR, library preparation,
sequencing and report generation. The key components leveraged
include the NovaSeq 6000, coupled with Illumina Tagmentation
library preparation technology, and the DRAGEN™ COVIDSeq Test
Pipeline for rapid reporting.
“COVIDSeq leverages the performance of NGS to help address the
global need for diagnostic testing to fight the COVID-19 pandemic,”
said Francis deSouza, Chief Executive Officer of Illumina. “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.”
COVIDSeq has not been FDA cleared or approved. This test is
authorized by FDA under an EUA for the duration of the declaration
that circumstances exist justifying the authorization of emergency
use of in vitro diagnostics for detection and/or diagnosis of
COVID-19. COVIDSeq is only authorized for use in laboratories in
the U.S., certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and
high complexity tests. Outside the U.S., COVIDSeq will be labeled
either as Research Use Only (RUO), or with labeling aligned with
local regulations.
For additional information, please visit
www.illumina.com/covidseq
About Illumina
Illumina is improving human health by unlocking the power of the
genome. Our focus on innovation has established us as the global
leader in DNA sequencing and array-based technologies, serving
customers in the research, clinical, and applied markets. Our
products are used for applications in the life sciences, oncology,
reproductive health, agriculture, and other emerging segments. To
learn more, visit www.illumina.com and follow @illumina.
Forward-Looking Statements
Certain statements contained in this press release may be
considered forward-looking statements within the meaning of Section
27A of the U.S. Securities Act of 1933, as amended, and Section 21E
of the U.S. Securities Exchange Act of 1934, as amended. Such
forward-looking statements involve risks and uncertainties,
including our expectations and beliefs regarding future conduct and
growth of our business and the markets in which we operate. Among
the important factors that could cause actual results to differ
materially from those in any forward-looking statements are: (i)
the impact of the COVID-19 pandemic to our business; (ii)
challenges inherent in developing, and launching new products and
services; (iii) the utility of such products and services; and (iv)
the speed and scale of their adoption by customers, together with
other factors detailed in our filings with the Securities and
Exchange Commission, including our most recent filings on Forms
10-K and 10-Q, or in information disclosed in public conference
calls, the date and time of which are released beforehand. We
undertake no obligation, and do not intend, to update these
forward-looking statements, to review or confirm analysts’
expectations, or to provide interim reports or updates on the
progress of the current quarter.
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