- Own developed SARS-CoV-2 Kit with PULB for COVID-19 uses real-time PCR (RT-PCR) technology on open PCR platforms, designed to provide results in approximately one hour
- 100% Sensitivity and 97.3% Specificity demonstrated in isolated RNA
- Inclusion of PCR-Compatible Universal Lysis Buffer (PULB) in the kit as a workflow option allows labs to circumvent the need for extraction equipment and reagents
GAITHERSBURG, Md., and HOLZGERLINGEN, Germany, Aug. 20, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, OpGen), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that its subsidiary Curetis GmbH has obtained the CE mark certification in the European Union for its own SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus that causes COVID-19.
Developed and manufactured by Curetis team in Germany, the SARS-CoV-2 Kit with PULB uses 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 COVID-19 by their healthcare provider or for screening of 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) provided in the kit. Including PULB in the kit as a workflow option allows labs to circumvent the need for extraction equipment and extraction kits/reagents, thereby providing operational and workflow efficiencies, time and cost savings. The kit is designed to provide time to results in approximately one hour, and it 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, COO of OpGen.
By launching this new product in Europe, we are committed to helping our distributors and customers to expand the availability of SARS-CoV-2 diagnostic testing, and our own-developed CE-IVD marked SARS-CoV-2 Kit with PULB is expected to help increase 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-to-result at favorable economics compared to many of the commercially available open PCR platform COVID-19 tests including the BGI SARS-CoV-2 kit. Having access to our own SARS-CoV-2 kit allows us to have that product distributed rather than the BGI test kit which we will cease distributing effective immediately.
About OpGen, Inc.OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGens product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.
For more information, please visit http://www.opgen.com.
Forward-Looking Statements by OpGenThis press release includes statements regarding the commercial launch of a SARS-CoV-2 Kit by OpGens subsidiary, Curetis GmbH. These statements and other statements regarding OpGens SARS-CoV-2 test kits, their commercialization and launch, future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the success of our commercialization efforts, the impact of COVID-19 on the Companys operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the realization of expected benefits of our business combination transaction with Curetis GmbH, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
OpGen Contact:Oliver SchachtCEOInvestorRelations@opgen.com
Press Contact:Matthew BretziusFischTank Marketing and PRmatt@fischtankpr.com
Investor Contact:Megan PaulEdison Groupmpaul@edisongroup.com
Source: OpGen, Inc.
- 8: Techniques of Molecular Genetics - Biology LibreTexts - January 23rd, 2024
- Molecular Genetics and Metabolism Reports - ScienceDirect - December 18th, 2022
- Molecular Genetics and Metabolism | Journal - ScienceDirect - December 18th, 2022
- Molecular clock - Wikipedia - December 2nd, 2022
- Molecular Structure of Nucleic Acids: A Structure for Deoxyribose ... - December 2nd, 2022
- Molecular Genetics School of Graduate Studies - University of Toronto - October 13th, 2022
- Molecular pathways of major depressive disorder converge on the synapse | Molecular Psychiatry - Nature.com - October 13th, 2022
- Can artificial intelligence help identify best treatments for cancers? LSU researchers say yes - The Advocate - October 13th, 2022
- Results for the fiscal year on June 30, 2022 - Yahoo Finance - October 13th, 2022
- From the journals: MCP - ASBMB Today - October 13th, 2022
- From cave-dweller scientist to Nobel laureate - The Tribune India - October 13th, 2022
- Animal Genetics Market - Know the Revenue and Profit-Sources of the Industry - openPR - October 13th, 2022
- Molecular and Cell Biology and Genetics - Master of Science / PhD ... - September 25th, 2022
- What does the future hold for COVID-19? - UCLA Health Connect - September 25th, 2022
- Farooq Kperogi: Lies and truth about Obi, Atiku, and Tinubu - Peoples Gazette - September 25th, 2022
- Atavistik Bio Announces Formation of Scientific Advisory Board - Business Wire - September 25th, 2022
- Scientific Advances Point to Improved Understanding of Radiation Exposure - Livermore Independent - September 25th, 2022
- 19 million to investigate bold ideas in bioscience research - EurekAlert - September 25th, 2022
- Machel, Iwer among full list of National Awardees - Trinidad Guardian - September 25th, 2022
- Newly Discovered Protein Connected to Alzheimers Disease Risk - Neuroscience News - September 25th, 2022
- The Lab Report: Sharma Lab studies biodiversity of arachnids - The Badger Herald - September 16th, 2022
- Environmental Scientist Jesse Ausubel to Receive 2022 Nierenberg Prize for Science in the Public Interest - Scripps Institution of Oceanography - September 16th, 2022
- Malaria vax promising, to be cheap too - The Hans India - September 16th, 2022
- Dayton Therapeutics Discovers New Therapeutic Uses of Satraplatin for Treatment of Rare Lymphomas - StreetInsider.com - September 16th, 2022
- JNCASRs novel molecule prevents obesity in mice - The Hindu - September 16th, 2022
- Research Fellow in the Department of Medical and Molecular Genetics job with KINGS COLLEGE LONDON | 308234 - Times Higher Education - September 8th, 2022
- Seven Queen's researchers elected to the Royal Society of Canada - Queen's University - September 8th, 2022
- Molecular Biology with an Industrial Placement Year BSc - India Education Diary - September 8th, 2022
- Whole Exome Sequencing Market Projected to Reach CAGR of 19.0% Forecast by 2029, Global Trends, Size, Share, Growth, Future Scope and Key Player... - September 8th, 2022
- Molecular prevalence and genetic diversity of Bartonella spp. in stray cats of zmir, Turkey - Parasites & Vectors - Parasites & Vectors - August 30th, 2022
- How light and temperature work together to affect plant growth - EurekAlert - August 30th, 2022
- Ancient Mummies' Lousy View of the Past - The Scientist - August 30th, 2022
- 'Gray blanket' over Australia: Genetics may have aided European rabbit invasion of continent in 1859, says study - Down To Earth Magazine - August 30th, 2022
- Meet the UNC Pembroke professor leading research on Alzheimers disease - The Robesonian - August 30th, 2022
- Massive Genome Study Informs the Biology of Reading and Language - Neuroscience News - August 30th, 2022
- People in the News at Gencove, IsoPlexis, HTG Molecular, More - GenomeWeb - August 30th, 2022
- Professor (with Head of Department potential), Department of Medical & Molecular Genetics job with KINGS COLLEGE LONDON | 304203 - Times Higher... - August 14th, 2022
- Kathy C. Cordes, a former Baltimore Sun artist who later worked at NASA's Space Telescope Institute, dies Baltimore Sun - Baltimore Sun - August 14th, 2022
- Discovery of the interactions between plants and arbuscular mycorrhizal fungi - EurekAlert - August 14th, 2022
- A new drug could repair stroke damage to memory and movement - Freethink - August 14th, 2022
- CDC Says Recent Flu Season Mild, Maybe Owing to COVID Precautions - Medscape - August 14th, 2022
- Study Using NanoStrings GeoMx Digital Spatial Profiler Featured on the Cover of Nature Genetics - BioSpace - August 14th, 2022
- New virus detected in China; here's everything you need to know about it - WCCO - August 14th, 2022
- Relief Therapeutics and Acer Therapeutics Announce that the European Commission Has Granted Orphan Drug Designation for ACER-001 in Maple Syrup Urine... - August 14th, 2022
- Psychiatry, Fraud, and the Case for a Class-Action Lawsuit - Mad In America - Mad in America - August 14th, 2022
- Scientists Grow Mouse Embryos Without Sperm Or Eggs - EverythingGP - August 14th, 2022
- The Pitfalls of Evolutionary Genomics - SciTechDaily - August 14th, 2022
- How a simple home DNA test unravelled the genetic code that could help prolong my life - The National - August 14th, 2022
- Graduate Research Officer job with UNIVERSITY OF WESTERN AUSTRALIA | 304277 - Times Higher Education - August 14th, 2022
- These Are the Degrees of the Future - Gizmodo - August 14th, 2022
- University of Chicago obituaries - University of Chicago - August 14th, 2022
- Letter: Abortion and social planning - Daily Herald - August 14th, 2022
- Postdoctoral Researcher, Seaweed Molecular Biology, Physiology and Genetics, Ryan Institute, School job with NATIONAL UNIVERSITY OF IRELAND, GALWAY |... - August 5th, 2022
- Researchers crack 30-year-old mystery of odour switching in worms - University of Toronto - August 5th, 2022
- 1st synthetic mouse embryos complete with beating hearts and brains created with no sperm, eggs or womb - Livescience.com - August 5th, 2022
- Rallybio Appoints Wendy K. Chung, M.D., Ph.D., to Its Board of Directors - Business Wire - August 5th, 2022
- Luke Goldman: Using eDNA to save the Atlantic cod - UMaine News - University of Maine - University of Maine - August 5th, 2022
- Duke Announces Winners of the 2022 DST Spark Seed Grants - Duke Today - July 27th, 2022
- WVXU: UC scientists are deep-freezing molecules. Here's why they're so excited about it - University of Cincinnati - July 27th, 2022
- Better Diagnosis and Treatment: Genetic Clues to Age-Related Macular Degeneration - SciTechDaily - July 27th, 2022
- Regeneron Announces the 2022 Winners of the Regeneron Prize for Creative Innovation - PR Newswire - July 27th, 2022
- Replay Launches with $55 Million Seed to Reprogram Biology by Writing and Delivering Big DNA - GlobeNewswire - July 27th, 2022
- How is Biotechnology revolutionising food and beverage industry? - The Statesman - July 27th, 2022
- ACP offers guidance on the ethical use of genetic testing and precision medicine - EurekAlert - July 27th, 2022
- Barbour Appointed Dean of The Graduate School and Vice Provost for Graduate Education - Duke Today - July 19th, 2022
- UC scientists are deep-freezing molecules. Here's why they're so excited about it - WVXU - July 19th, 2022
- Research Fellow, Molecular Biology / Recombinant Protein Production and Purification (Biol Sci) job with NATIONAL UNIVERSITY OF SINGAPORE | 301436 -... - July 19th, 2022
- UF researchers discover new way to inhibit virus that causes COVID-19 - University of Florida - July 19th, 2022
- Streamlined Genomic Testing Platforms Are Taking on A Bigger Role in Cancer Care - OncLive - July 19th, 2022
- Bachelor of Science in Biology - National University - July 19th, 2022
- Genes may influence our successes and failures in life, according to Professor Kathryn Paige Harden - ABC News - July 19th, 2022
- Lecturer for Department of Experimental Biology job with MASARYK UNIVERSITY | 301048 - Times Higher Education - July 19th, 2022
- Lecturer in Biology (Education Focused) job with UNIVERSITY OF SYDNEY | 300815 - Times Higher Education - July 19th, 2022
- People's University Is All About Dinosaurs This Summer - Wheeling Intelligencer - July 19th, 2022
- Radiologists hope to use AI to improve readings - University of Miami: News@theU - July 19th, 2022
- Rare Disease Genetic Testing Market 2022 Emerging Trends, Comprehensive Study With Top Companies and Key Players till 2030 - Taiwan News - July 11th, 2022
- Proteases implicated in ulcerative colitis - ASBMB Today - July 11th, 2022
- Cancer has been a scourge for centuries, advances in science have made the disease far less intractable - The Indian Express - July 11th, 2022
- Scientists discover key genes behind insect migrations - EurekAlert - July 11th, 2022
- Neuroimaging Techniques and What a Brain Image Can Tell Us - Technology Networks - July 11th, 2022