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Siemens Healthineers Gets FDA Emergency Use Authorization for Molecular Coronavirus Test

NEW YORK ─ The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for Siemens Healthineers' Fast Track Diagnostics SARS-CoV-2 test to detect the coronavirus that causes COVID-19.

The test can be used for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens, such as nasal, nasopharyngeal, and oropharyngeal swabs; nasopharyngeal or nasal aspirate; and bronchoalveolar lavage, the FDA said on its website.

The agency added the test involves first extracting, isolating, and purifying SARS-CoV-2 nucleic acid from the specimen. Purified nucleic acid is then reverse transcribed into cDNA prior to its PCR amplification and detection using an authorized real-time PCR instrument.

The company's SARS-CoV-2 Assay has been optimized for use with the BioMérieux EasyMag Extraction System and the Thermo Fisher Scientific Applied Biosystems 7500 Real-time PCR Thermocycler, but it can be validated for use with many other laboratory molecular instruments, according to Siemens Healthineers.

Siemens Healthineers received CE marking for the test in April, allowing for its use as a clinical diagnostic test in Europe.

The assay was developed by the company's Fast Track Diagnostics business, which it acquired in 2017.