ROTOP Pharmaka GmbH

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Member of MDG produces & distributes COVID-19 test

Dresden, 2. April 2020 - Biotech company Biotype is producing and offers a diagnostic test for SARS-CoV-2 (COVID-19)

Dresden, April 2, 2020. The German company Biotype GmbH based in Dresden Hellerau is commissioned to produce components for the Corona Virus COVID-19 genesig® Real-Time PCR Test by Primerdesign Ltd. In order to meet the high demand, the Biotype team produces seven days a week in a 2-shift system. A daily capacity of 8,000 to 10,000 tests is planned. A gradual increase in the weekly production volume is already being scheduled. In addition to its production capabilities, Biotype GmbH provides its worldwide distribution network to bring the IVD assay to where it is urgently needed. Interested state examination institutes (LUA), test laboratories hospitals and independent test laboratories can order the test kit from Biotype via e-mail.
"Since the first cases of a respiratory disease appeared in the Chinese city of Wuhan in December 2019, we have been working on the novel virus. In the meantime, this infectious disease has developed into a global pandemic and poses an unprecedented challenge for our healthcare system. Biotype accepted the challenge and worked together with the British company Primerdesign Ltd. to produce a test system. Our goal was to be able to meet the high and still strongly growing demand for in-vitro diagnostic tests and to make as many tests available as possible," says Dr. Wilhelm Zörgiebel, managing partner of Biotype GmbH.
Biotype produces subcomponents of Primerdesign´s Corona-Virus COVID-19 test and distributes the assay worldwide. The Corona Virus COVID-19 genesig® Real-Time PCR Test detects the current SARS-CoV-2 virus strain in a highly specific manner. To maintain high specificity, continuously published virus sequences are evaluated with the test in a daily surveillance program. The corona virus COVID-19 test will be performed in laboratories using the most prevalent qPCR (quantitative polymerase chain reaction) platforms. The British company Primerdesign is a leader in the development and production of molecular diagnostic test kits (MDx), so-called assays. Their clinical diagnostic kit is CE-IVD registered and consequently can be used for in-vitro diagnostic applications in Europe. “Its advantage is that it quickly - within two hours - detects only the current SARS-CoV-2 strain and no other related coronavirus strains," says Karim Tabiti, managing director of Biotype GmbH.
Biotype has also established its own LDT (Laboratory Developed Test) for SARS-CoV-2 detection using its innovative and powerful Modaplex platform. This system has been established in cooperation with the American pharmaceutical company Eli Lilly, which will use the system for SARS-CoV-2 detection in the USA. Additionally, Biotype GmbH is in discussions with decision-makers in the German federal state of Saxony regarding the high throughput use of the system in the state.
Biotype is thus supporting the Saxon State Ministry of Science, Culture and Tourism (SMWKT) and the Saxon State Ministry of Social Affairs and Social Cohesion (SMS) in the implementation of a "Saxon solution" with which a larger number of patients can be tested for the corona virus throughout the state. The Dresden-based company is working closely with its scientific partners on this project. These are the Fraunhofer Institute for Cell Therapy and Immunology (IZI), the university clinics in Leipzig and Dresden, and the Dresden health authority. "We are proud to be part of the fight against the corona virus," says Zörgiebel.


Contact person for the distribution of the COVID-19 diagnostic test kit:
Peter Rademacher, Head of Sale, E-Mail: sales@biotype.de

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ROTOP Pharmaka has taken appropriate measures in order to be able to guarantee production and delivery capability over a longer period of time. The situation is continuously monitored by our crisis management team. Further measures will be taken, if necessary.


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