Lifecare – Corona antigen rapid test approved for clinical study – 25.08.20

Lifecare’s partner Digital Diagnostics AG has received approval for clinicaltests from the responsible ethics committee and the Federal Institute for Drugsand Medical Devices (BfArM) in Germany. This is a decisive regulatory step inthe ongoing regulatory process for the Digid Cantisense™ SARS-CoV-2 test inGermany. The Digid Cantisense ™ SARS-CoV-2 antigen test for immediate virusdetection is based on ground-breaking proprietary technology, hence the approvalprocesses are thorough and time consuming. Lifecare AS (LIFE-ME) has a 25% ownership in Digital Diagnostics AG as part of awider technology cooperation and joint venture with the German company.Digital Diagnostics applied to the Federal Institute for Drugs and MedicalDevices (BfArM) for approval of the Digid Cantisense ™ SARS-CoV-2 test forGermany at the beginning of June 2020. The BfArM has now permitted clinicaltrials to be carried out. Meanwhile, the ethics committee of the State MedicalAssociation of Rhineland-Palatinate has also given a positive endorsement.The aim of the test series is to demonstrate a comparable reliability of therapid test as with conventional PCR tests. With the new test, which isparticularly suitable for access control and rapid tests, for example atairports, in hospitals or at large-scale events, SARS-CoV-2 viruses can bedetected directly onsite in just a few minutes.“We are very pleased with the positive results from the regulatory scrutiny inGermany. While we would wish for a speedier regulatory approval process, wehighly appreciate the thoroughness and long hours put in at the German and USregulatory bodies. We expect that the clinical tests will confirm DigitalDiagnostics claims and meet the regulatory expectations, and we expect theproduct will be a robust solution fighting the pandemic”, says ChristianHysing-Dahl, chairman of the board of Lifecare AS.The clinical tests of the digital biosensor and the measuring device areexpected to be completed in October 2020. If the results are positive, the rapidtest is expected to be approved shortly afterwards. In the study, patients are tested simultaneously both with a standard PCR methodand with the Digid Cantisense ™ SARS-CoV-2 test. For this purpose, a throat swabis taken from the patient by the medical staff. The aim of the study is to usethe Digid instant test to meet the reference values of a PCR laboratory test.The study will continue until at least 30 patients with positive PCR resultshave been tested. This also corresponds to the requirements of the EU Commissionfor in-vitro measurement methods for the detection of SARS-CoV-2.In contrast to the PCR method, the new antigen test delivers clear electronic"YES" or "NO" information within a few minutes and saves the detour to alaboratory and valuable time during diagnosis. In addition, the Digid Cantisense™ SARS-CoV-2 test directly detects the presenceof the virus, while other available rapid tests mainly detect antibodies.However, patients only develop these antibodies if they have been infected forseveral days and have already been contagious. For this reason, rapid antibodytests are only of limited use in containing the spread of the pandemic.Press contactRune Frisvold, Lifecare COOTel: +47 9013 60