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Bruker Invasive Fungal Disease Products CE-IVD Marked

NEW YORK (GenomeWeb) – Bruker today announced it has received CE-IVD marking for two products aimed at diagnostic and susceptibility testing of invasive fungal diseases.

Following the CE-IVD marking, Bruker also launched the two products, the Fungiplex Candida assay, and the Micronaut-AM test plate. The Fungiplex Candida assay is a multiplex real-time PCR-based test for the rapid identification of the most common pathogens associated with invasive candidiasis. It allows for the early identification of Candida infection without the need for blood culture and is validated against DNA extracted from whole blood, serum, and plasma, Bruker said. The company added that the assay detects the main causative agents of invasive candidiasis, including C. albicans; C. parapsilosis; C. tropicalis; and C. dubliniensis. It also differentiates C. krusei and C. glabrata, and can provide results in two to three hours directly from patient samples.

The Micronaut-AM test plate — acquired when Bruker bought Merlin Diagnostika last month — is for the automated or manual antifungal susceptibility testing of yeast from cultures. The Micronaut technology is based on the phenotypic detection of microbial growth inhibition in the presence of antibiotics, and the test plate enables the testing of nine antimycotics — including anidulafungin, caspofungin, and posaconazol — in 11 concentrations. It also provides a standardized workflow for analysis with visual or photometric interpretation, Bruker said.