OpGen Announces Results from Successful Webinar on Bacterial Pneumonia Co-infections in COVID-19 Patients
Experts presented the results of their Unyvero studies and demonstrated:
- Distinguishing those COVID-19 ICU patients with bacterial superinfection early and accurately is crucial for patient management and antibiotic stewardship
- Unyvero detected bacterial pathogens up to 7 days earlier and would have enabled prompt and appropriate targeted antibiotics in 41.3% of cases and reduced time to appropriate therapy by 25.7 hours
Professor and Senior Consultant Physician
- Unyvero demonstrated higher diagnostic yield (25.3% more detections) than bacterial culture, including several key pathogens of concern such as S. aureus, P. aeruginosa, S. marcescens, H. influenzae, K. oxytoca, S. maltophilia. Notably, S. maltophilia was called out as an important target on the Unyvero panel because of its intrinsic resistance against many of the standard antibiotics.
- Analysis of chart reviews of patients that had multiple lower respiratory cultures ordered during the course of their hospital stay revealed two clinically important cohorts:
- In Group 1, culture and Unyvero HPN results were 100% concordant on the first and all subsequent samples that had been ordered. The findings in this cohort demonstrated that Unyvero HPN would enable significantly more rapid detection of pathogens not covered by empiric therapy due to intrinsic resistance, i.e. S. maltophilia, or multidrug resistant organisms (MDROs), i.e. carbapenem-producers, within 5 hours vs. 2.5 days by culture.
- In Group 2, Unyvero HPN detected bacterial pathogens up to 7 days earlier in patient samples that were initially negative by culture but subsequent cultures ordered during hospital stay were confirmed as positive for the same pathogen at a much later stage. As a consequence of lack of finding any microbial etiology by culture, this group of patients were exposed to longer duration of empirical antibiotic treatment. This group also had longer hospital length of stay (LOS), longer ICU LOS and longer VAP duration, which could have been shorter if antibiotics could have been tailored and targeted earlier. “The potential impact of Unyvero HPN in this group could be significantly greater than in Group 1,” stated
Prof. Giske, as he presented several clinical cases of patients with ongoing infection where culture exhibited intermittent detection of pathogen(s) impacted by antibiotics across serial sampling while Unyvero HPN demonstrated consistent and steady detection of these pathogen(s). Prof. Giskepointed out that similar findings were reported1 by Pickens et al. where chart reviews were performed on 4 culture-negative Acinetobacter cases that Unyvero had reported positive for Acinetobacter, and subsequent cultures grew Acinetobacter. In these cases, empiric therapy did not adequately cover for Acinetobacter and all four patients died.
The second presentation focused on a number of clinical cases from the Unyvero LRT BAL study that exemplify the performance characteristics and potential clinical impact of this Unyvero panel in pneumonia diagnostic algorithms, presented by
Analysis of retrospective chart reviews performed on these patients revealed that, based on conventional microbiological results, 41% were undertreated, 19% were overtreated, while only 25% were appropriately treated and 16% were appropriate without antibiotic treatment. In contrast, the study demonstrated that using the Unyvero LRT BAL panel would have enabled prompt and appropriate targeted antibiotic therapy in 41.3% of cases, including escalations (i.e. detection of S. aureus and mecA 11 to 18 hours earlier than culture), and de-escalations (i.e. detection of M. catarrhalis, which would have enabled de-escalation from piperacillin/tazobactam and azithromycin to amoxicillin clavulanate in just 5 hours), and reduced time to appropriate therapy by 25.7 hours.
This presentation also called out the fact that Pneumocystis jirovecii is a non-culturable fungus, and in the absence of PCR testing, PJP diagnosis relies on microscopic examination of trophic forms or cysts, which is laborious and insensitive. Clinical cases were presented which demonstrated the rapid and reliable detection of Pneumocystis jirovecii using the Unyvero LRT BAL panel in just 5 hours with only about 2 minutes of hands-on time.
Key comments and concluding remarks from
A recording of this webinar can be accessed at OpGen.com.
About Unyvero HPN and LRT BAL
The Unyvero Hospitalized Pneumonia (HPN) panel detects 21 clinically relevant pathogens and 19 antibiotic resistance markers in less than five hours directly from native specimens with only around 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
For more information, please visit www.opgen.com.
Forward-Looking Statements by
This press release includes statements regarding the results of studies conducted by independent infectious disease professionals presented at a recent webinar on OpGen’s Unyvero HPN and Unyvero LRT BAL panels and their potential clinical benefits. These statements and other statements regarding OpGen’s Unyvero products, 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 fact that we may not effectively use proceeds from recent financings, including our
FischTank Marketing and PR
Source: OpGen, Inc.