QIAGEN Plans to Resubmit EUA Submission in the U.S. for QIAreach SARS-CoV-2 Antigen Test in the First Quarter of 2021

Rhea-AI Summary

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) plans to resubmit its QIAreach SARS-CoV-2 Antigen Test to the U.S. FDA for Emergency Use Authorization in Q1 2021 after withdrawing its initial submission in November 2020 due to a chemistry-related issue. The company believes the issue has been resolved and is currently collecting data for resubmission. QIAGEN's CEO, Thierry Bernard, emphasized their commitment to expediting the process to assist in COVID-19 testing. Despite this, the company does not expect any impact on its full-year 2021 sales or adjusted earnings.

Positive

• Resubmission of the QIAreach test anticipated to enhance COVID-19 testing capacity for U.S. customers.
• The company believes it has resolved the chemistry-related issue from the initial submission.

Negative

• The initial submission was withdrawn due to unresolved chemistry-related issues.

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/

FAQ

When does QIAGEN plan to resubmit the QIAreach SARS-CoV-2 Antigen Test?

QIAGEN plans to resubmit the QIAreach SARS-CoV-2 Antigen Test to the FDA in the first quarter of 2021.

What was the reason for QIAGEN's withdrawal of the QIAreach test submission?

The submission was withdrawn to address a chemistry-related issue.

Will the resubmission of the QIAreach test impact QIAGEN's financial outlook?

QIAGEN does not expect the resubmission to impact its outlook for full-year 2021 sales and adjusted earnings.

What is the purpose of the QIAreach SARS-CoV-2 Antigen Test?

The QIAreach SARS-CoV-2 Antigen Test is designed to detect SARS-CoV-2 antigens in people with active infections in 15 minutes.

How does the QIAreach test process samples?

The QIAreach test is capable of processing over 30 swab samples per hour and provides digital test results.