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.
Siemens Healthineers is adding more firepower in the fight to make more novel coronavirus (SARS-CoV-2) diagnostics available.
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.
Editorial Disclaimer: information published during the 2020 COVID-19 pandemic may be updated frequently to reflect the dynamic nature of current understanding.
- Abbott launches COVID-19 antibody test
- Roche develops new COVID-19 antibody test
- Hologic’s molecular test for SARS-CoV-2 receives FDA Emergency Use Authorization
- Cepheid molecular test for the qualitative detection of SARS-CoV-2
- Commercially available COVID-19 diagnostic tests