Regulatory approval for the highly sensitive, high-speed coronavirus test system by GNA Biosolutions
Coming up with reliable figures for the process of infection with the coronavirus requires tests that are dependable and, above all, quick. With the Octea SARS-CoV-2 system, GNA Biosolutions has developed a molecular, highly sensitive test method that delivers a test result with 96.7 percent accuracy in decentralized laboratories in approximately 40 minutes’ time. Octea is thus comparable to the PCR tests. Special approval for Octea by the German Federal Institute for Drugs and Medical Devices (BfArM) represents an important step in the effort to combat the coronavirus pandemic. GNA seeks CE approval for Europe-wide use of the test system.
Detailed information can be found here: https://t1p.de/gcj5