QIAGEN Plans to Resubmit EUA Submission in the U.S. for QIAreach SARS-CoV-2 Antigen Test in the First Quarter of 2021
January 20 2021 - 4:08PM
Business Wire
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced that it plans to resubmit in the first quarter of 2021
its QIAreach SARS-CoV-2 Antigen Test to the U.S. Food and Drug
Administration for Emergency Use Authorization to detect SARS-CoV-2
antigens in people with active infections in 15 minutes.
This comes after QIAGEN decided to proactively withdraw the
first submission made in November 2020 for this product to address
a chemistry-related issue. QIAGEN believes it has resolved the
issue, and data is now being collected for submission to the FDA.
The eHub used to read out test results is not affected.
“We are working closely with the FDA to ensure that all
necessary information is submitted as quickly as possible so that
we can make this product available as a solution in the fight
against the COVID-19 pandemic, as many U.S. customers have
expressed significant interest in using QIAreach to expand their
testing capacity,” said Thierry Bernard, Chief Executive Officer of
QIAGEN.
QIAGEN launched the QIAreach SARS-CoV-2 Antigen test in November
2020. The QIAreach™ SARS-CoV-2 Antigen Test, developed in
partnership with the Australian digital diagnostics company Ellume,
is designed to process more than 30 swab samples per hour,
providing digital test results that do not require subjective
interpretation, and allowing antibody tests to run simultaneously
with antigen tests.
QIAGEN does not expect this decision to have an impact on the
outlook for full-year 2021 sales and adjusted earnings, as
communicated in December 2020.
Please find the full press release here.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210120005687/en/
QIAGEN Investor Relations John Gilardi, +49 2103 29 11711
Phoebe Loh, +49 2103 29 11457 ir@QIAGEN.com
Public Relations Thomas Theuringer, +49 2103 29 11826
Robert Reitze, +49 2103 29 11676 pr@QIAGEN.com
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