Qiagen said it will once again file submission for emergency use authorization (EUA) for its QIAreach SARS CoV-2 Antigen Test. The measure comes after the Hilden, Germany-based company decided to proactively withdraw the first submission made in November 2020 for this product to address a chemistry-related issue.
Qiagen said it has resolved the issue, and data is now being collected for submission to FDA. The eHub used to read out test results is not affected.
The test detects SARS-CoV-2 antigens in people with active infections in 15 minutes.
“We are working closely with 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,” Thierry Bernard, CEO of Qiagen, said in a release.
The company said it 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.