NEW YORK – Midge Medical has obtained the CE-IVD mark for professional use of a point-of-care diagnostics system and COVID-19 test. The firm announced on Tuesday that the system was CE marked in May, ahead of the implementation of the In Vitro Diagnostic Regulation in the European Union.
Midge plans to launch the system and the COVID-19 test in Germany in the fourth quarter of 2022.
The system, called Minoo, detects SARS-CoV-2 in patient samples using reverse-transcriptase recombinase polymerase amplification, or RT-RPA, within 18 minutes, the Berlin, Germany-based firm said in a statement.
A "palm-size, fully digitally integrated rapid test system," the Minoo also marks the first commercial POC system to use RPA chemistries, the firm said.
A validation study of 649 inactivated samples in transport media showed the COVID-19 test on the Minoo had a 98 percent specificity and a sensitivity of 98.6 percent compared to a PCR assay kit run on the Qiagen Rotor-Gene system for Ct values higher than 38. The Minoo also had 100 percent PCR equivalence for Ct values of 30 and below.
"We have built the Minoo test system from the ground up to provide affordable and scalable state-of-the-art digital integration and a lay user-centric approach, in order to address the key challenges in the current diagnostic testing market," said Michael Diebold, cofounder and CEO of Midge Medical.
The firm expects to provide additional assays for point-of-care molecular rapid testing market, Diebold also said.