NEW YORK – An investigator-initiated, randomized controlled trial found that the use of OpGen subsidiary Curetis' Unyvero Hospitalized Pneumonia (HPN) panel lowered the duration of inappropriate antibiotic therapy among hospitalized patients.
OpGen anticipates that these data, published last month in The Lancet, will help drive sales of the panel by providing physicians with greater confidence in the product.
"These are the kinds of findings that customers are looking for," said Faranak Atrzadeh, OpGen's chief marketing and scientific affairs officer.
Oliver Schacht, OpGen's CEO, explained that potential customers have frequently stated that they need to see clear outcomes data before deciding whether the pneumonia panel, and the Unyvero platform more generally, might add value to their practices.
"Here we have a clinical trial that was done over several years," he added, "prospectively, randomized, tightly controlled, with interventional use of the Unyvero data and results in one patient cohort compared to the control group where doctors had standard-of-care microbiology results only."
The HPN panel covers 21 pathogens and 17 antimicrobial resistance (AMR) markers, providing results in a little under five hours. The rapid multiplex PCR-based platform employs a closed cartridge-based approach used for specimen lysis, DNA extraction, PCR, and array hybridization and is CE marked and commercially available in CE-compliant countries.
The Unyvero Lower Respiratory Tract panels – LRT and LRT BAL – are essentially the same as the HPN panel but are cleared by the US Food and Drug Administration and commercially available in the US. The main difference between the panels is that the LRT and LRT BAL cover 20 pathogens and 10 AMR markers.
The slight drop in coverage of that panel, Schacht said, is due to the rarity of certain pathogen-AMR marker combinations.
"The prevalence is so low," he explained, "that despite running large prospective multicenter trials, we simply didn't get a large enough number to demonstrate that it works. So at the end, that's what the FDA cleared."
In the recently published trial, individuals examined with OpGen's panel, as opposed to conventional microbiology, spent an average of 38.6 fewer hours on inappropriate antibiotic therapy (47.1 hours vs 85.7 hours for those examined by conventional microbiology).
Patients in this group were also treated less overall with broad-spectrum antibiotics and were often given smaller doses when these were prescribed. The reductions did not result in adverse reactions affecting clinical stability, ICU admission, hospital readmission, or 30-day mortality, compared to the control group.
"One of the key reasons why AMR is now such a global health threat is exactly due to inappropriate use of antibiotics," Atrzadeh said. This, she explained, generally consists of both remaining on broad-spectrum antibiotics unnecessarily and using antibiotics that aren't targeted to an infection's causative agent.
The Unyvero HPN demonstrated a sensitivity and specificity for Gram-negative rods of 55.6 percent and 86.6 percent, respectively, in line with past assessments, where factors such as sample origin, clinical setting, variability in microbial culture comparators, and the use of a first-generation or a newer panel showed sensitivity ranges of 57 to 97 percent and specificities of 14 to 99 percent.
Although the Unyvero HPN appears to be the only AMR panel to have yet completed randomized controlled trial testing, others are following suit.
BioMérieux's BioFire FilmArray Pneumonia plus Panel, for instance, is being evaluated in the INHALE study, currently underway in the UK.
The INHALE RCT is the third part of the larger INHALE Project, which in parts one and two evaluated the Unyvero platform and the MinIon sequencing platform, from Oxford Nanopore. The investigators behind this project selected the BioFire FilmArray, also a highly multiplexed PCR panel, as "the best performing test to carry forward" into the clinical trial.
The BioFire Pneumonia platform is also being assessed in several other prospective trials, including the multicenter MULTI-CAP trial in France and SARIPOC trial of critically ill adults with pneumonia, also in the UK.
Beyond the HPN panel, OpGen is focused on developing further applications of the Unyvero platform.
The company continues to enroll participants in its urinary tract infection panel clinical trial and expects to complete enrollment during the summer, with trial data becoming available in the second half of the year, followed by a filing for FDA clearance.
The UTI panel is currently commercially available in the US for research use only as it progresses through that trial and Schacht reported high interest for the product among labs and clinicians.
OpGen also hopes to get its invasive joint infection panel into clinics by the end of the year.
While the general plan for the Unyvero HPN panel at the moment is "place more systems, sell more cartridges, get it utilized," Schacht said, the next big milestone will be fully commercializing it in China.
While the Unyvero platform recently gained Chinese regulatory approval, the pneumonia cartridge itself still awaits approval, pending the completion of a study that was paused due to COVID-related lockdowns in China.
"Once they reopen and get out of their lockdown," said Schacht, "hopefully that study gets underway. That approval is the next big step for the pneumonia panel broadly."