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.
The drug-device combination measures activity of live organisms by detecting metabolites, and can be used to indicate virulence and guide treatment.
The three-year extension increases the minimum purchase commitments for the Unyvero system, resulting in an increase in potential revenues of €30 million to Curetis.
The Envisia test uses RNA sequencing and machine learning to diagnose idiopathic pulmonary fibrosis.
Sales were driven by a strong flu season and growth in Asia-Pacific business.