OpGen Announces Release of – GuruFocus.com
- The results were published in the European Journal of Clinical Microbiology & Infectious Diseases
- Serial sample analysis confirms correct pathogen detection by Unyvero HPN
- Additional pathogens detected by Unyvero PNH confirmed in many cases by culture positivity for the same microorganism in another specimen obtained from the same patient
- This observation highlights the ability of Unyvero HPN to detect potential pneumonia pathogens earlier than culture
ROCKVILLE, Md., June 22, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help fighting infectious diseases, today announced the release of a new publication in a peer-reviewed journal from a study conducted at Karolinska University Hospital (KUH), Solna, Stockholm, Sweden. The publication highlights the ability of the Unyvero Hospitalized Pneumonia Panel to detect potential pneumonia pathogens earlier than culture or very early in an infection.
The performance characteristics of the Unyvero Hospitalized Pneumonia Panel, relative to microbiological culture for the detection of bacterial pathogens from lower respiratory tract specimens obtained from critically ill patients with COVID-19, have been recently published1 by investigators from the Karolinska Institute. Study results demonstrated that Unyvero HPN provides higher diagnostic yield than bacterial culture. This enables reliable and rapid diagnosis of pathogens of concern in these patients directly from native lower respiratory tract specimens, and allows identification of bacterial co-infections in hospitalized patients with COVID-19 pneumonia in just five hours. .
In their new publication titled “Evaluation of a Pneumonia Multiplex PCR Panel for the Detection of Bacterial Airway Pathogens from Serial Specimens Collected from Hospitalized COVID-19 Patients2“, investigators conducted a follow-up study to examine concordant and discordant results comparing Unyvero PNH and culture results for the detection of microorganisms from serial samples taken from the same patient.
Sixty-nine samples obtained from 27 adult subjects (fifteen patients with two, nine patients with three, and three patients with four samples taken on different days) admitted to the intensive care unit with COVID-19 were included. Data were categorized by complete agreement (Unyvero results were identical for the presence or absence of one or more pathogens per culture), correlation agreement (Unyvero was positive for a pathogen that was culture negative from the same specimen but was culture positive in a previous or subsequent specimen from the same patient within ±7 days), partial agreement (Unyvero detected the same pathogens that were detected by culture plus pathogens additional pathogens that were not detected by culture and failed to achieve agreement by correlation), discrepancy (a pathogen on the panel was culture positive but was not detected by Unyvero; results discordant were also considered when a sample had only one pathogen detected by Unyvero but was not detected by culture), concordance and disco rdance (specimens that were positive for more than one pathogen by Unyvero but were not detected by culture; one pathogen was concordant by correlation by culture in a previous or subsequent specimen from the same patient within ±7 days, the other pathogen was not detected by culture).
The results were analyzed in two ways: The first evaluation (Evaluation I) was performed in a typical way for a comparative study where the Unyvero results were compared to the culture results by subject. The second assessment (Assessment II) explored the interpretation of false-positive Unyvero results that were later substantiated by culture of a different specimen taken at a later or earlier time from the same patient. In this approach, all Unyvero false positive results were considered true positives, if culture confirmed that result for any other sample (earlier or later) from the same subject. This latter approach highlights an important point as the published literature reports comparisons of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with the assumption that conventional microbiological techniques are 100% sensitive. and specific when in fact microbiological culture is recognized as being far from being an optimal gold standard due to its diagnostic performance3.
Several key findings emerged from this study:
- Unyvero detected at least one additional pathogen in 20/69 (29%) of the samples tested.
- Additional pathogens detected by Unyvero in 12/20 samples (60%) were detected by culture from a previous or next sample collected (±7 days) and tested on the same subject in six samples each.
- This observation highlights the ability of the Unyvero panel to detect a potential pneumonia pathogen earlier than culture or very early in an infection.
Investigators reported that Unyvero detected an additional pathogen in at least one sample taken from 14/27 (52%) patients. Of these 14 patients, 10 of them had exposure to antibiotics prior to collection of specimens for culture and it is plausible that exposure to antibiotics had a negative influence on the yield of cultures from these specimens. The authors conclude that “additional pathogens detected by Unyvero PNH from a given lower respiratory tract specimen could be confirmed in many cases by culture positivity for the same microorganism from a previous specimen. or later obtained from the same subject. This observation highlights the ability of Unyvero HPN to detect a potential pneumonia pathogen earlier than culture and/or very early during infection.
Faranak Atrzadeh, Director of Marketing and Scientific Affairs, OpGen, commented, “The results of this study highlight the accurate and reliable performance of the Unyvero Pneumonia Panel and its diagnostic and clinical utility in detecting bacterial pneumonia earlier in order to enable faster and more appropriate antibiotic treatment”.
About Unyvero Lower Airway and Inpatient Pneumonia Panels
The Unyvero Hospitalized Pneumonia (HPN) Panel detects 21 clinically relevant pathogens and 17 antibiotic resistance markers in less than five hours directly from native specimens with only approximately two minutes of hands-on time, compared to routine bacterial cultures that can take up to several days for confirmatory pathogen identification and antimicrobial susceptibility testing results. In the United States, the Unyvero LRT and LRT BAL panels for the rapid detection of lower respiratory tract infections such as pneumonia are FDA cleared for tracheal aspirate specimens and bronchoalveolar lavage fluids, respectively. Unyvero HPN and LRT BAL are the only syndromic multiplex PCR panels for lower respiratory tract infections that also include Pneumocystis jiroveciia causative agent of Pneumocystis pneumonia (PCP) and a key fungal pathogen often found in immunocompromised patients and which can be difficult to diagnose.
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, USA) is a precision medicine company that harnesses the power of molecular diagnostics and bioinformatics to fight infectious disease. Together with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we develop and market molecular microbiology solutions that help guide clinicians with faster, actionable insights into life-threatening infections to improve patient outcomes and reduce the spread infections caused by multidrug-resistant diseases. microorganisms or MDRO. OpGen’s product portfolio includes Unyvero®, Acuitas® AMR Gene Panel and the ARES technology platform, including ARESdb®, utilizing NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.
For more information, please visit www.opgen.com.
This press release includes statements regarding the release of results from a recent Unyvero Hospitalized Pneumonia Panel study. These and other statements regarding OpGen’s future plans and objectives 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 of 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 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, the success of our marketing efforts, our ability to develop, seek out and successfully, timely and cost-effectively obtain the regulatory clearance and commercialization of our product and service offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use the proceeds of recent financings, the continued realization of the expected benefits of our business combination transaction with Curetis GmbH, the continued impact of COVID-19 on the Company’s operations, financial results and marketing efforts as well as on capital markets and general economic conditions, our ability to service our debts under our loan to the European Investment Bank ent, the effect of military action in Russia and Ukraine on our distributors, associates and service providers, our liquidity and working capital requirements, 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 see 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.
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