Skip to main content
Premium Trial:

Request an Annual Quote

GNA Biosolutions Gets German Emergency Use Authorization for Coronavirus Test System

NEW YORK — GNA Biosolutions said on Tuesday that its Octea SARS-CoV-2 batch testing system has received Emergency Use Authorization from the German Federal Institute for Drugs and Medical Devices.

The system is based on a proprietary PCR technology, called pulsed control amplification, that uses short electrical pulses to drive rapid amplification cycles and can amplify nucleic acids directly from samples without additional preparation.

The molecular test system includes GNA's portable Octea analyzer and a test kit designed to detect SARS-CoV-2 in oropharyngeal swabs. Up to eight samples can be tested in a single run, with results available within 40 minutes, according to the Munich-based company.

With the EUA, "our GNA Octea SARS-CoV-2 Test System can uniquely enable molecular diagnosis of COVID-19 in decentralized labs here in Bavaria and across Germany," GNA Cofounder and CEO Federico Buersgens said in a statement. "Our next step will be to obtain CE marking for the GNA Octea SARS-CoV-2 Test System in the first quarter of 2021 to expand our reach across Europe."

In 2019, GNA raised $13.5 million in a Series C financing round.

The Scan

Not Yet a Permanent One

NPR says the lack of a permanent Food and Drug Administration commissioner has "flummoxed" public health officials.

Unfair Targeting

Technology Review writes that a new report says the US has been unfairly targeting Chinese and Chinese-American individuals in economic espionage cases.

Limited Rapid Testing

The New York Times wonders why rapid tests for COVID-19 are not widely available in the US.

Genome Research Papers on IPAFinder, Structural Variant Expression Effects, Single-Cell RNA-Seq Markers

In Genome Research this week: IPAFinder method to detect intronic polyadenylation, influence of structural variants on gene expression, and more.