20 January 2021 - - German sample and assay technologies provider Qiagen N.V. (NYSE: QGEN) plans to resubmit in 1Q21 its QIAreach SARS-CoV-2 Antigen Test to the US Food and Drug Administration for Emergency Use Authorization to detect SARS-CoV-2 antigens in people with active infections in 15 minutes, the company said.

This comes after the company decided to proactively withdraw the first submission made in November 2020 for this product to address a chemistry-related issue.

Qiagen said it 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.

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.