OpGen (OPGN) Reports Publication of Results from Major Clinical Study Using Unyvero Hospitalized Pneumonia (HPN) Panel

OpGen, Inc. (Nasdaq: OPGN) announced today the release of a new peer-reviewed journal publication from a major investigator-initiated, multicenter, randomized, controlled and interventional trial conducted at two tertiary care centers in Switzerland (University Hospital of Basel and Kantonsspital St. Gallen). The trial demonstrates that using Unyvero HPN panel in hospitalized pneumonia patients for the examination of bronchoalveolar lavage (BAL) in combination with antibiotic stewardship decreases the duration of inappropriate antibiotic therapy of hospitalized patients with pneumonia at risk for Gram-negative bacteria and supports antibiotic de-escalation in 66% of patients.

In this publication titled “Fast multiplex bacterial PCR of bronchoalveolar lavage for antibiotic stewardship in hospitalized patients with pneumonia at risk of Gram-negative bacterial infection (Flagship II): a multicentre, randomized controlled trial1,” the authors assessed the clinical utility and impact of the Unyvero panel in hospitalized adult patients with suspicion of pneumonia, a clinical indication for bronchoscopy and at risk for infection with Gram-negative bacteria. The primary study endpoint was duration of inappropriate antibiotic therapy defined as the time in hours on inappropriate antibiotic therapy from bronchoscopy to discharge or up to 30 days after bronchoscopy. Secondary endpoints were time to clinical stability, length of hospital stay in days, mortality within 30 days, adverse events (safety), and diagnostic performance of the Unyvero panel assessed for BAL compared with conventional microbiological testing.

A total of 740 patients with pneumonia were screened; 208 eligible patients were randomized of whom 100 were assigned to the intervention group (also referred to as the PCR group); in this intervention group, the BAL specimen was analyzed by conventional culture as well as determination of Gram-negative bacteria using the Unyvero HPN panel; the other 108 patients were randomized to the control group where the BAL sample was analyzed solely by conventional microbiology culture. The Unyvero results for Gram-negative bacteria were disclosed to the attending physician treating the patients in the intervention group approximately 5 hours after bronchoscopy.Several key findings emerged:

• The duration of inappropriate antibiotic treatment was decreased by 39 hours in the PCR group; Unyvero reduced the duration of inappropriate antibiotic therapy to 47 hours (vs. 86 hours in the control group), p<0.0001. The low P-value suggests a high statistical significance of this result.
• Inappropriate antibiotic therapy was reduced by 45% in the Unyvero group (p<0.0001).
• The overall duration of antibiotic therapy was 22.5% shorter in the Unyvero group.
• Patients treated in the Unyvero group had a three times higher probability of appropriate antibiotic therapy (p<0.0001).
• A reduction in the use of broad-spectrum antibiotics or decreasing the amount of antibiotics in the Unyvero group did not have any adverse effects on clinical stability, ICU admission, hospital readmission or 30-day mortality, compared to the control group.
• Gram-negative bacteria in BAL were detected more commonly by Unyvero than conventional microbiological culture in 39 patients vs. in 30 patients, respectively.

On diagnostic performance, the authors commented that “the accuracy of bacterial PCR is usually measured using culture as the reference standard, although microbiological culture is far from being an optimal gold standard due to its diagnostic performance.” In this study, they showed that Unyvero has a higher sensitivity than conventional microbiological culture when clinical syndrome or imaging is used as the reference standard.

The authors concluded that “this study is the first multicenter, randomized controlled trial showing that results from a multiplex bacterial PCR panel of bronchoalveolar lavage incorporated into antibiotic stewardship translate into less inappropriate antibiotic therapy. Accordingly, the duration of inappropriate antibiotic therapy was reduced in the PCR group with no compromise in clinical outcomes, including time to clinical stability, length of stay in the hospital, and mortality.”

Faranak Atrzadeh, OpGen’s Chief Marketing and Scientific Affairs Officer commented: “Pneumonia caused by Gram-negative bacteria is often associated with poor diagnosis and a high mortality rate. This multicenter, randomized, interventional study demonstrates the importance of rapid and accurate molecular diagnostics and the significant and actionable impact of the Unyvero hospitalized pneumonia panel on timely initiation of antibiotic therapy in patients with pneumonia.”

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