Midge Medical Receives CE-IVD Mark for Minoo Test System
Midge Medical received a CE-IVD mark for its molecular minoo test system as rapid testing for SARS-CoV-2.
The system, palm-sized and indicated for professional point of care, is the only product on the market that commercially utilizes long-established recombinase polymerase amplification (RPA) biochemistry in order to accurately detect viruses, the company said.
A validation study comparing the system to PCR gold standard CE-IVD-PCR Kit Rotogene demonstrated that the minoo test system had diagnostic sensitivity of 98.6 percent and specificity of 98 percent.
“There is a medical and economic need for decentralized, accurate and affordable diagnostic testing solutions beyond pandemics,” said Michael Diebold, company co-founder and CEO.
The company has made plans to introduce this system to the German market in the fourth quarter of this year.