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 thermocycler is a point-of-care diagnostic system that enables real-time molecular testing in hospitals, clinics, physician offices, and the field.

The kit detects 29 mutations in exons 18, 19, 20, and 21, and has a limit of mutation detection at .1 percent in a background of wild-type DNA.

The British-based firm says that its assay detects hepatitis C via a single-use, disposable cartridge within 90 minutes of testing. 

The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology. 

Based on iCubate's Amplicon-Rescued Multiplex PCR technology, the iC-GPC assay is the first of the company's portfolio's to earn CE mark.

The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.

The company's new QuantStudio 5 Dx Real-Time PCR system allows users to wield multi-modal software to detect pathogens.

The tubes enable noninvasive collection and preservation of biomarkers, such as circulating or total nucleic acids, and protein and cellular biomarkers.