The LRT BAL panel detects a wide spectrum of clinically relevant causative agents, such as atypical pathogens and antibiotic resistance markers.
The study reflects the importance of including multiple biomarkers for diagnostic and treatment decisions associated with pneumonia, IVD industry experts said.
Within the "Big Three" conditions, misdiagnoses related to stroke, sepsis, and lung cancer accounted for the most high-severity diagnostic error cases.
For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.
The BioFire FilmArray Pneumonia panel will be used to optimize clinical trial enrollment for an antibiotic to treat combat carbapenem-resistant A. baumannii infections.
The submission by Curetis' distribution partner Beijing Clear Biotech used data previously collected for regulatory approvals in the US and Europe.
The new regulatory approvals add to previous approvals in Singapore, expanding the firm's reach in the Association of Southeast Asian Nations region.
The company will rely more on distribution partners in Europe for its Unyvero product line while continuing highly targeted commercialization efforts in the US.
The company is developing a new gold standard comparator test after it encountered problems with typical culture methods it used in developing a new pneumonia assay.
The BioFire FilmArray Pneumonia Panel was cleared by the FDA while the BioFire FilmArray Pneumonia Panel Plus was CE marked.