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Monday, March 16, 2020

OpGen Curetis Offers BGI’s CE-IVD Rapid Test Kit for Coronavirus in Europe

– Rapid real-time PCR test allows testing for SARS-CoV2 in only a few hours
– Test kit to be made available via Curetis’ European sales channels
– Synergies with Curetis Unyvero HPN panel for pneumonia testing for bacterial co-infections in Covid-19 patients 
OpGen, Inc. (OPGN) reported an update on the business of Curetis GmbH (“Curetis”), the other party to the planned business combination with OpGen. Today, Curetis announced that it started offering a CE-IVD certified real-time PCR test kit for SARS-CoV2 (also known as 2019-nCov), the causal pathogen of Corona Virus Disease 2019 (Covid-19). The test kit was developed and is manufactured by Curetis’ strategic partner BGI (Shenzhen, China) and was cleared by Chinese authorities in January 2020. In compliance with European regulations for in-vitro-diagnostics (IVD) tests, the test kit was CE-IVD certified on February 28, 2020.
The BGI 2019-nCoV RT-qPCR Kit enables diagnostic laboratories to perform SARS-CoV2 testing of nasopharyngeal swabs and bronchoalveolar lavage fluid of patients suspected to suffer from Covid-19. The test kit is compatible with standard methods for extracting the virus’ nucleic acid from the sample such as the QIAamp Viral RNA Mini Kit (QIAGEN) and can be performed on standard real-time PCR instruments such as the Applied Biosystems 7500 Real-Time PCR System (ThermoFisher Scientific) that are available in many molecular diagnostic laboratories in Europe. The test kit includes all necessary reagents and controls to test up to 48 patients in just a few hours.
The test will be made available to diagnostic laboratories in Europe through
Curetis network of distribution partners but – owing to the special circumstances of the global SARS-CoV2 outbreak – also directly by Curetis in countries where Curetis’ distribution partners are not set up to supply the test kit themselves at short notices.
https://finance.yahoo.com/news/opgen-provides-curetis-now-offering-113010764.html

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