midge medical GmbH has received a CE-IVD mark for its SARS-CoV-2 PoC-NAT professional use “minoo” rapid testing system

• Accurate positive and negative test results digitally available after only 18 minutes 
• Only system in the global rapid molecular, palm-size scanner testing market utilizing evolutionary, field-tested RT-RPA technology
• Now focusing on next milestones: advanced multiplexing platform, anywhere usability and 10 additional commercially attractive new assays beyond SARS-CoV-2 
• Product developed and produced in Germany
• New funding round started 

midge medical GmbH, an innovative diagnostic start-up headquartered in Berlin, Germany, has announced that its palm-size, rapid and easy-to-use molecular minoo test system was awarded a CE-IVD mark for Sars-CoV-2 rapid testing for professional Point of Care use on May 23, 2022. The company is now set to introduce this testing system to the German market in the fourth quarter of 2022. 

The minoo palm-size, fully digitally integrated rapid test system is the only product on the market which commercially utilizes evolutionary, long-established and robust Recombinase Polymerase Amplification (RPA) biochemistry in order to accurately detect viruses and thus provide actionable information without unnecessary delays. The minoo test system needs only 18 minutes to provide reliable positive and negative test results. 

A large-scale performance validation study (n=649 inactivated transport medium samples) compared the minoo test system with the PCR gold standard (CE-IVD-PCR Kit, Rotogene). The minoo test system demonstrated a very high diagnostic sensitivity of 98.6% up to PCR CT values of >38 and a 100% PCR equivalence up to CT values of 30 as well as a 98% specificity.    

Michael Diebold, the co-founder and CEO of midge medical, comments: “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.”  

The ongoing pandemic has dramatically demonstrated the limitations of today’s lab-based testing dominance, while the clinical and economic value of accurate, fast, digitally integrated, affordable and decentralized molecular testing has been clearly established in pandemics, says Diebold. However, there is a medical and economic need for decentralized, accurate and affordable diagnostic testing solutions beyond pandemics. “We see ongoing tailwinds for this new, fast-growing diagnostic market segment in other indications which we are currently exploring. We anticipate a growing commercial market, independently of the testing regimes imposed by governments during the pandemic.”

Large companies, start-ups, sports teams, critical infrastructure etc cannot afford a large number of sick days or the negative workforce impact resulting from post- and long Covid. Regular molecular decentralized testing of workforces or individuals is likely the most effective means of detecting infections early on and avoiding super spreader events.  

Diebold: “We took our SARS-CoV-2 minoo test system from a product idea to a CE mark and achieved its initial commercialization in less than 2.5 years. We are looking forward to similarly achieving all our future milestones in record time and bringing further improvements to the decentralized rapid testing market. We are especially excited about realizing our strategic objectives of providing a large number of new assays for the molecular rapid testing market, for use at the point of care or anywhere.”

Our mission: Professional diagnostics in every home, for any indication.

We make medical testing available to everyone, by bringing it into people’s homes.