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Home  /  Forum  /  Curetis  /  Curetis-Opgen 2022 / Zal het dan dit jaar wat worden ?

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Aandeel OpGen OTC:OPGN.Q, US68373L4068

  • 0,600 17 apr 2024 21:59
  • -0,044 (-6,89%) Dagrange 0,580 - 0,638
  • 152.754 Gem. (3M) 1,7M

Curetis-Opgen 2022 / Zal het dan dit jaar wat worden ?

49 Posts
Pagina: «« 1 2 3 | Laatste | Omlaag ↓
  5. forum rang 4 Pitmans 1 november 2022 17:49
    Ach verdammt noch mal, deze had ik even gemist.
    De omzet in heel Q3 is nog minder dan alleen het jaarsalaris van de CEO heer Schacht.
    Ze zouden zich kapot moeten schamen, maar dat doen ze vast niet.

    OpGen Announces Preliminary Unaudited Revenue and Cash Position for Third Quarter 2022 and Provides Business Update

    OpGen, Inc.
    Thu, October 27, 2022 at 1:30 PM

    Preliminary Total Revenue for Q3 2022 was approximately $0.4 million

    Cash as of September 30, 2022 was approximately $10.3 million and as of October 3, 2022 was approximately $13.3 million

    Additional customer contract for Acuitas AMR Gene Panel signed in Q3 2022

    ROCKVILLE, Md., Oct. 27, 2022 (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 total preliminary unaudited revenue for the third quarter of 2022 was approximately $0.4 million, down from $1.2 million in the third quarter of 2021. Cash as of September 30, 2022 was approximately $10.3 million and, following the successful closing of a financing transaction, was approximately $13.3 million as of October 3, 2022.

    The company announced accomplishment of the following key milestones and recent developments in the third quarter of 2022:

    - OpGen subsidiary Curetis and BioVersys signed a collaboration agreement for clinical trial support

    - OpGen signed another commercial customer contract for the Acuitas AMR Gene Panel

    - OpGen closed a registered direct offering for gross proceeds of $3.38 million on October 3, 2022

    - OpGen announced successful completion of clinical trial enrollment for the Unyvero Urinary Tract Infection Panel

    - OpGen subsidiary Curetis and FIND signed a R&D collaboration agreement for the Unyvero A30 RQ platform

    - Nasdaq granted OpGen a 180-day extension to meet Nasdaq’s minimum bid price requirement

    - OpGen launched ARES sequencing services in the U.S. from its Rockville, Maryland laboratory

    - OpGen subsidiary Ares Genetics GmbH entered into a collaboration agreement with the Belgian national reference center for invasive S. pneumoniae at University Hospital Leuven

    Mr. Schacht commented, “We have seen a decrease in revenue in Q3 2022 compared to last year’s third quarter due to the completion of the New York State Department of Health project in Q3 last year, and lower than expected ARES sales. Our preliminary quarterly results do not reflect the potential impact from the FIND collaboration agreement, which is expected to culminate with a series of milestones and deliverables at the end of Q1 2023. Acuitas sales are not reflected in the third quarter numbers at a material level either, since the first couple of sites became operational with completed systems installations and trainings in October. We have been informed by Beijing Clear Biotech’s regulatory advisors about NMPA feedback regarding our Unyvero A50 pneumonia product which would require us to re-submit in China under a new electronic filing regime. We are in dialog with them to gain further insights and assess the potential impact on the overall process and timelines and will provide an update as soon as practicable.”
  7. p/o 13 december 2022 14:13
    Fantastisch nieuws voorlopig vallen ze over elkaar om te kopen:

    Opgen OPGN: premarket hoogste koers: $0.2865 + 0.1615 (+ 129.21%)
    Pre-Market Volume 8,729,441

    OpGen Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection Panel

    Study has enrolled over 1,800 patient samples at 4 U.S. clinical trial sites

    Primary endpoint for Unyvero UTI for urinary tract infection shows overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% in preliminary analysis

    Clinical performance results will be used to prepare submission package for FDA De Novo request

    ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen’s Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens. The test aims at quantitative detection of microorganisms.

    The trial was designed to compare the performance of the Unyvero UTI Panel for detecting urinary tract infections (UTI), using clean-catch or catheter related urine samples. Preliminary analysis of all prospectively enrolled samples showed that the primary study endpoint was successfully met by demonstrating an overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% when compared against each trial site’s standard of care microbiology results. These findings are also in line with the interim analysis performed during the first part of the trial.

    The trial included a total of 1,858 prospective and archived samples and has run over 3,300 Unyvero cartridges, including controls and reproducibility tests performed at the different trial sites. In addition to local microbiology laboratory results and additional standardized central microbiology data from an independent reference laboratory, OpGen is currently generating next-generation sequencing (NGS) data at its Rockville, MD, lab facility to also allow genotypic correlation of antibiotic resistance markers detected during the study. Based on the results of the unblinded data set, testing of additional contrived samples with well-characterized pathogen strains will complement and provide additional data points for low prevalence strains and antibiotic resistance markers. Based on all the data generated and analyzed, OpGen will now start preparing a De Novo request package for submission to the U.S. FDA in due course.

    “Having completed the study as planned, we have successfully generated a large and very comprehensive study data set with multiple reference methods. We’d like to thank our study sites for their contributions in generating these data.”, said Johannes Bacher, Chief Operating Officer of OpGen. “Now that we have unblinded the results, we are excited to proceed with our in-depth analysis and compile the data submission to the FDA over the next few months.”

    "Urinary tract infections represent a major healthcare burden, and diagnosing complicated UTI remains challenging. Microbiological cultures take several days to provide definitive results. Pathogenic microbial species may not be detected due to prolonged exposure to antibiotics, and complex polymicrobial infections may be difficult to elucidate. The Unyvero UTI Panel is a new and promising multiplex molecular test for the rapid detection of a comprehensive range of pathogenic bacteria, fungi, and their associated resistance markers directly from urine in under five hours. Rapid results enable early diagnosis and effective antibiotic therapy to help prevent serious complications in UTI patients," said Dr. Christopher Emery, Associate Director of Clinical Microbiology, Indiana University Health Pathology Laboratory (IUHPL), Indianapolis, IN.

    OpGen intends to present data from the study at a future conference as well as to submit for a peer reviewed publication.

    Disclaimer
    Caution - Investigational Device, Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute or imply an offer to sell or transfer any product. Performance characteristics for this device have not yet been established and the U.S. FDA has not yet cleared the panel.

    About OpGen, Inc.

    OpGen, Inc. (Rockville, MD, U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our 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. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
49 Posts
Pagina: «« 1 2 3 | Laatste |Omhoog ↑

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