The firm is now in talks with commercialization and distribution partners to make the test widely available in Europe and other markets that recognize the CE mark.
Following the CE-IVD marking, Bruker launched the two products, the multiplex real-time PCR-based Fungiplex Candida assay and the Micronaut-AM test plate.
The test leverages loop mediated isothermal amplification technology and enables the rapid detection of Neisseria meningitidis directly from cerebrospinal fluid samples.
The company aims to wrap up field trials for the system by the end of this year and will seek European regulatory clearance thereafter.
Since it launched CADscor, which could compete against molecular tests, in the second quarter, Acarix has announced clients in Germany, Denmark, and Sweden.
The platform, comprising immunoassay and chemistry analyzers, was previously cleared by the FDA, and is now available in Europe, the US, South America, and Asia.
VisualDx, maker of an image-based clinical decision support system, has a new app to help iPhone users analyze skin lesions nearly instantaneously.
UgenTec and R-Biopharm's collaboration will cover the software's development, regulatory approval, and launch.
The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology.
The latest offering puts the genetic testing company on the path toward becoming what it calls a preventive health service company.