Siemens Developing New Diagnostic for COVID-19

The Erlangen, Germany-based company said its Fast Track Diagnostics (FTD) SARS-COV-2 Assay is already being shipped in Europe for research use only. Siemens Healthineers is looking at speaking with FDA to release the test under Emergency Use Authorization.

The company said its Fast Track Diagnostics (FTD) SARS-COV-2 Assay is already being shipped in Europe for research use only (RUO) to expedite availability while it continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for clinical use.

In addition, the company is in talks with FDA to release the test under Emergency Use Authorization (EUA). Siemens said while these measures are in effect it also expanding its production capacity.

Siemens inherited the assay when it acquired Luxembourg-based Fast Track Diagnostics in December of 2017.

“With this molecular diagnostic assay, we want to make a contribution to fight the current COVID-19 global pandemic by delivering fast and accurate SARS-CoV-2 testing,” Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers, said in a release. “The Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with the necessary next steps on their patients’ triage paths.”

Siemens’s test comes at a time when there are more than one million SARS-CoV-2 cases and 51,563 deaths worldwide, according to statistics from worldometer.com. The test also comes on the heels of Abbott Laboratories receiving EUA for a five-minute test. The news caused Abbott shares to jump – during a time when most medtech stocks are down.