Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.

Family Genetic Risk Score Linked to Diagnostic Trajectory in Psychiatric Disorders

Researchers in JAMA Psychiatry find ties between high or low family genetic risk scores and diagnostic stability or change in four major psychiatric disorders over time.

Study Questions Existence of Fetal Microbiome

A study appearing in Nature this week suggests that the reported fetal microbiome might be the result of sample contamination.

Fruit Fly Study Explores Gut Microbiome Effects on Circadian Rhythm

With gut microbiome and gene expression experiments, researchers in PNAS see signs that the microbiome contributes to circadian rhythm synchronicity and stability in fruit flies.