Early 2020, Lifecare established a collaboration for development with German partners, and Digital Diagnostics (Digid) was founded in Mainz, Germany. Lifecare has a 25% ownership in Digid, whose mission is to develop a digital diagnostics platform built upon its proprietary nanotech biosensor technology and an ecosystem of mobile applications to enable real-time, A.I-powered diagnostics of human and animal biodata. The collaboration includes the completion of Lifecares Sencell technology in exchange for a non-exclusive and non-competing licence under which Digid can utilize Lifecare’s technology, patents, and other IP.
Lifecare has filed for permission to carry out a «Pilot Evaluation on Humans» for its glucose measuring technology Sencell in Germany, but due to COVID-19 these clinical trials have been postponed. Besides general delays in scientific environments due to the pandemic, the delay was also based on an intentional strategic decision. Digids development of its rapid test for detecting SARS-CoV-2 viruses required and was given internal priority. Although the new priority caused some delay in developing Sencell, it still triggered increased development in some of its areas, which means the timeline regarding CE marking of Sencell is not delayed.
Digid has filed for approval of its rapid test detecting COVID-19 in the US (FDA) and in Germany (BfArM). The application processes have taken more time than initially estimated but are still within normal progressions of such processes in the two countries. In August, Digid received an approval from BfArM to carry out clinical trials in Germany. These are expected to be conducted in October and provided positive results approval may be possible shortly after.
Lifecare’s forthcoming activities include existing and new development related to its core technology within diabetes, Sencell, including the aim of developing medical technology suitable for commercialisation.