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.