GAITHERSBURG, Md., And HOLZGERLINGEN, Germany, Aug. 20th. 2020 (GLOBE NEWSWIRE) – OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a pharmaceutical company that uses the power of molecular diagnostics and bioinformatics to help fight infectious diseases, announced today that its subsidiary Curetis GmbH has received CE mark certification in the European Union for its own SARS-CoV-2 Kit with PULB for detecting SARS-CoV-2, the virus that causes COVID-19.
The SARS-CoV-2 Kit with PULB was developed and manufactured by Curetis’ team in Germany, using real-time reverse transcription polymerase chain reaction (RT-PCR) technology for qualitative detection of the SARS-CoV-2 virus isolated from oropharyngeal and nasopharyngeal swab specimens from individuals suspected of having COVID-19 by their healthcare provider or for screening asymptomatic individuals. This kit can be used with RNA isolated by performing standard RNA isolation processes, as well as with oropharyngeal or nasopharyngeal swabs collected in PCR-compatible viral transport medium treated with PCR-compatible Universal Lysis Buffer (PULB) supplied in the kit. Incorporating PULB into the kit as a workflow option allows laboratories to embrace the need for extraction equipment and extraction kits / reagents, providing operational and workflow efficiency, time and cost savings. The kit is designed to deliver time in results in about one hour, and runs on open real-time PCR instruments such as the QuantStudio ™ 5 Real-Time PCR system and the Bio-Rad CFX96 ™ Real-Time PCR Detection System.
“The CE-IVD marking is an important step in advancing our efforts to support critical COVID-19 testing; the Curetis SARS-CoV-2 Kit with PULB provides additional testing capacity in countries that recognize the CE mark to test patients, ”said Johannes Bacher, COG of OpGen.
“By launching this new product in Europe, we are working to help our distributors and customers expand the availability of SARS-CoV-2 diagnostic tests, and our own developed CE-IVD branded SARS-CoV-2 Kit with PULB expected to help increase the availability of these much-needed tests, “said Oliver Schacht, PhD, CEO of OpGen.” Our customers will benefit from an optimized workflow and a test that delivers great performance and significantly shorter time-on-result in favorable economy compared to many of the commercially available open PCR platforms COVID-19 tests, including the BGI SARS-CoV-2 kit. By accessing our own SARS-CoV-2 kit we can distribute that product instead of the BGI test kit that we will stop distributing immediately effectively. ”
OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company that leverages the power of molecular diagnostics and bioinformatics to help fight infection. Together with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiological solutions that help guide clinicians with rapid and actionable information on life-threatening infections to improve patient outcomes, and reduce the spread of infections caused by multidrug-resistant microorganisms, such as MDROs. OpGen’s product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, with NGS technology and AI-driven bioinformatics solutions for antibiotic response prediction. “Data-reactid =” 23 “>About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company that leverages the power of molecular diagnostics and bioinformatics to help fight infection. Together with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiological solutions that help guide clinicians with rapid and actionable information on life-threatening infections to improve patient outcomes, and reduce the spread of infections caused by multidrug-resistant microorganisms, such as MDROs. OpGen’s product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb, with NGS technology and AI-driven bioinformatics solutions for antibiotic response prediction.
Please visit www.opgen.com for more information.
Source: OpGen, Inc.
