First Rapid Corona Antigen Test Approved for Clinical Study in Germany

The health tech company Digital Diagnostics AG from Mainz, Germany, has received approval for clinical trials from a German ethics committee and the Federal Institute for Drugs and Medical Devices (BfArM). This is a crucial regulatory step in the ongoing approval process for the Digid Cantisensetm SARS-CoV-2 test in Germany. The aim of the clinical trials is to demonstrate the reliability of the new technology in comparison with conventional PCR tests. The new test is particularly suitable for access control at airports or at large-scale event

MAINZ, Germany, Aug. 25, 2020 /CNW/ -- In June 2020, the health technology company Digital Diagnostics AG from Mainz, applied for approval of the Digid Cantisensetm SARS-CoV-2 test for Germany at the German Federal Institute for Drugs and Medical Devices (BfArM). BfArM has now permitted the conduct of clinical trials in accordance with Section 20 (1) of the German Medical Devices Act (MPG). Meanwhile, the ethics committee of the Rheinland-Pfalz Medical Association (Landesärztekammer) has also given a positive vote.

Completion of the clinical evaluation of the Digid biosensor and the accompanying reading device is expected in October 2020. If the results meet expectations, the rapid Cantisensetm test shall be approved in short succession. Digital Diagnostics AG will then be able to launch the tests on the market in millions. The company currently develops the necessary production capacities, ready for use in time right after the approval.

The leading center to carry out the clinical trials is PFÜTZNER Science & Health Institute in Mainz, which works closely with scientists and MDs from corona test centers and clinics throughout Germany. It is planned to perform the study locally as well as in known German corona hotspots.

In the study, patients are tested in parallel with a standard PCR method and with the Digid Cantisensetm SARS-CoV-2 test. Like with all common SARS-CoV-2 determinations, medical staff takes a throat swab from the patient. The sample is analyzed directly on site with the Digid rapid test system and afterwards compared with the result of a PCR test from a reference laboratory to demonstrate the accuracy of the Digid Cantisensetm SARS-CoV-2 test. The design of the study complies with FDA and EU Commission guidelines for in-vitro measurement procedures to detect SARS-CoV-2.

One key advantage of the Digid Cantisensetm SARS-CoV-2 test is that it directly detects the presence of the virus in the sample, while other available rapid tests mostly detect antibodies. Patients only develop these antibodies if they have had an infection for several days, a time during which they were contagious and might unknowingly have infected others. With the unique combination of immediate on-site detection of the virus in tested patients, the Digid Cantisensetm SARS-CoV-2 test is particularly useful to contain the spread of the pandemic and suitable for on-site access control and rapid testing, for example at airports, in hospitals or at large-scale events.

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SOURCE Digital Diagnostics AG