Scientific breakthrough: Lifecare’s partner Digital Diagnostics AG detects corona virus with rapid test, seeks FDA approval and plans to deliver units starting in July

Digital Diagnostics has filed for U.S. Food and Drug Administration (FDA) approval. Starting in July, Digital Diagnostics is planning to deliver tests, followed by upscaling of capacities in the short term.

In contrast to PCR testing, the Digid Cantisense™ SARS-CoV-2 Test provides a clear electronic “YES” or “NO” information within a few minutes, saving precious time in the diagnosis. It directly detects the presence of the virus, while other rapid tests only recognize antibodies. Antibodies form after a patient was infected and contagious for several days. Therefore, today’s rapid antibody tests are of limited use to contain the spread of the pandemic.

Christian Saure, Chairman of Lifecare, said: “The Digid Cantisense™ SARS-CoV-2 Test can detect corona virus from the time of infection, contrary to other tests on the market that can only detect the antibodies 5-7 days after the infection. The accurate and quick on-site testing, which is independent of lab analysis, will really help contain the current SARS-COV-2 pandemic. The scientific breakthrough and timeline for point-of-care tests is a leap in revolutionizing SARS-CoV-2 diagnostics. Digital Diagnostics fast-track development and positioning represent a significant value potential for Lifecare as a partner and shareholder.”

Konstantin Kloppstech, CTO at Digital Diagnostics, says: “Recent test series at the HZI high-security laboratory have shown that SARS-CoV-2 viruses can be detected directly and reliably using our Cantisense technology and without the need for PCR or further sample processing. This is a scientific breakthrough. We have coated cantilevers with a capture layer of highly specific monoclonal antibodies, which can reliably bind SARS-CO-2 viruses in the test fluid.”

Constantin von Gersdorff, CEO of Digital Diagnostics, said: “The next step will be to initiate clinical studies with patient samples. To this end, we have already established international collaborations with leading hospitals in Europe, Africa and Asia”.

With Digid’s point-of-care solution, the measurement results are transmitted wirelessly from a sensor hub to a mobile device. By connecting to a secure analytics platform, the numerous sensor data can be augmented with further data and processed anonymously for research and diagnostic applications.

Due to its measurement speed and the highly reliable results, the Digid Cantisense™ SARS-CoV-2 Test is particularly suitable to support the containment of the current SARS-CoV-2 pandemic. The test offers the possibility of simple and rapid testing of patients and medical staff as an alternative to laboratory tests and enables reliable identification of infected persons within minutes. The possible areas of application therefore also include screening for access control at airports and railway stations, hospitals and specially protected areas (such as retirement and nursing homes) as well as for companies who want to ensure that their production runs smoothly and safely.

The experts at Digital Diagnostics are also working at full-speed to further develop the technology and to adapt the point-of-care testing procedure for consumers at home.

Partner Consortium

digid — Digital Diagnostics AG, Mainz, Berlin

Helmholtz-Zentrum für Infektionsforschung (HZI), Braunschweig

Department of Biotechnology am Institut für Biochemie, Biotechnologie und Bioinformatik der Technischen Universität Braunschweig

Laboratories for Natural Product and Conjugation Chemistry (naconLabs)

Division Microrobotics and Control Engineering (AMiR), University of Oldenburg

Centre for Biosensors, Bioelectronics and Biodevices, University of Bath

Łukasiewicz-Instytut Technologii Elektronowej, Warschau

Lifecare AS (Ltd.), Bergen, Norway

Pfützner Science & Health Institute, Mainz