Diagenics Group SE is launching two new, easy-to-perform COVID-19 antigen tests under the DIA-COVID test family

● Within the framework of the initiative of the German Federal Government and the Federal Ministry of Health, the previous COVID-19 strategy has been supplemented since mid-October 2020 by the important component of rapid antigen tests. „With rapid antigen tests we are improving the protection of people in nursing homes and hospitals," said German Health Minister Spahn when announcing the new strategy. A corresponding test ordinance came into force in mid-October 2020.

● In this context, the company Diagenics Group SE reacted quickly and has now launched two corresponding rapid antigen tests to the market, and sales will start immediately in Germany and Europe.

● The new antigen tests are now approved for the German and European markets, on the list of COVID antigen tests of the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn.

● The Diagenics DIA-COVID Antigen/Flu combination test also works with a simple nasal swab and supplements the COVID diagnostic options, since only one measurement is sufficient to differentiate between flu viruses and COVID-19, BfArM in process.

● Additional COVID-19 antibody test is also available now throughout Europe as DIA-COVID Antibody IgG/IgM Rapid Test and is a useful addition to COVID-19 measurements, as it shows the initial and further antibody formation in later phases of the infection. This test is based on the drawing simply a drop of blood and can differentiate between IgG/IgM (early/late antibodies that are formed in the patient's blood against the virus) between.

● The DIA-COVID-19 rapid tests are each based on the lateral flow principle. Both tests provide the result in just 15 minutes, without the need for additional diagnostic tools to run it.

● The new rapid antigen tests are critical in slowing down the spread of the new Coronavirus, and in many cases preventing it, as they provide information at a time point or the infection cycle when the risk of the spreading disease is very high.

Essen, 3. December, 2020 - Diagenics Group SE announced today that the company has developed two easy-to-use rapid antibody tests for the detection of the new coronavirus, which can be used immediately and are already have been listed with the Federal Institute for Drugs and Medical Devices (BfArM) to detect the Covid-19 virus. These antigen rapid tests are both exclusively available for medical specialists and accordingly can be used in the context of COVID-19 defense measures accompanied by doctors or medical experts or medical technical staff as part of the catalog of measures by companies and institutions, as well as doctors, hospitals, retirement homes and other organizations. The tests each work “stand alone”, as all the necessary components are already included in the test kit and thus can be ran immediately with a nasal swab and delivers the result within 15 minutes.

"This fast, directly usable antigen tests can enable COVID-19 testing on a large scale, so that affected persons are supported immediately and thus the spread of the virus can be slowed down and, in many cases, prevented," says Ernest Kapetanovic, CEO of Diagenics Group SE.

“Diagenics Group SE has used its many years of experience and networks in the field of IVD (in-vitro diagnostics) and point-of-care diagnostics to develop and use this efficient antigen test technology with suitable partners. Diagenics is currently launching these tests to Germany and Europe and they are now available to the relevant specialists,” continues CEO Kapetanovic.

Increasing the detection rate with rapid antigen COVID-19 test
The antigen test detects the nucleocapsid protein as part of the COVID-19 virus to determine whether someone is currently infected. Since these tests detect infections at the beginning of the infection cycle, the spread of the infection can be contained by taking appropriate measures. In order to contain the spread of the virus, the possibility of a large-scale COVID-19 test in Germany is important.

DIA-COVID tests:

● These tests promote the support of COVID-19 measures by public institutions, companies and organizations in carrying out rapid antigen tests.

● Due to the easy access, inexpensiveness and quick results, more tests can be performed in a short time. The DIA-COVID Ag rapid tests use the proven lateral flow principle and can deliver the result in just 15 minutes.

● Another member of the DIA-COVID test family is a combination test which can be is suited to measure both flu viruses (Influenza A/B) and the new coronavirus simultaneously in one measurement. This test is now available under the name Covid-19 Flu A/B-Antigen-Combo-Test.

● The product portfolio of Diagenics also includes a DIA-COVID IgG/IgM antibody rapid test.

"Diagenics is in process to register and officially list the DIA-COVID Influenza A/B-Antigen Combination Test at the Federal Institute for Drugs and Medical Devices (BfArM)," confirms CEO Ernest Kapetanovic.

About the DIA-COVID Ag rapid test
The DIA-COVID Ag rapid test is a point-of-care test for the rapid and qualitative detection of the SARS-CoV-2 virus. No additional confirmation test is required. However, a negative result can neither rule out a COVID-19 infection nor be used as the sole reason for treatment or essential decisions. Negative results must therefore be combined with clinical observation, anamnesis and epidemiological information.

The preliminary results of a clinical study conducted within Diagenics network on 548 patients show that the DIA-COVID Ag test has a sensitivity of 96.86% and a specificity of 100.0% for suspected COVID-19 infection or with evidence of symptoms occurring in the last seven days. In addition, Diagenics will submit information about this test to the World Health Organization (WHO) for inclusion in the emergency summary.

Possible interview partners:
Ernest Kapetanovic, CEO & President, Diagenics Group SE
Sam Yastas, Member of the Board, Diagenics Group SE
Dr. rer. nat. Ralf Axel Hilger, University Hospital Essen, West German Cancer Center

To make contact to any of these or other interview partners, please contact us.

Published by:
DIAGENICS GROUP SE
European Headquarters
Corporate Communications
Alfredstrasse 98, D-45131 Essen

Fon: +49 201 874 29 500
Fax: +49 201 874 29 510
Mail: info@diagenics.com
Web: www.diagenics.com

About Diagenics Group SE
Diagenics is a biopharmaceutical company with branches and partners in Europe and the US and is a pioneer in innovative diagnostics for the early detection of important diseases such as heart attack (ACS - Acute Coronary Syndrome), Stroke and Preeclampsia, a disease where in the western world 7-8% of all pregnancies are affected. This early detection is based on a new and innovative biomarker that was developed by Diagenics. The diagnostic results are faster and more accurate, which in turn is inexpensive and reduces the frequency of misdiagnosis. Further, Diagenics is now working more closely with customers on the COVID-19 issue to offer antigen tests for medical professionals as well as companies and institutions in Germany and Europe. The European distribution center for DIA-COVID rapid tests is located in Essen, Germany.

Forward-looking statements
This press release contains certain statements addressed to the future, which are based on the current assumptions and prognoses of the corporate management of Diagenics Group SE. Various known and unknown risks, uncertainties and other factors can lead to a deviation from the here stated assumptions to the actual results, financial situation and development or performance of the company. The company takes no responsibility for adjusting the here presented statements to future events or developments.

This release was published on openPR.