The test showed 90 percent sensitivity and 75 percent specificity in a 250-patient blinded study, even without the addition of clinical risk information.
In 2018 Thermo Fisher posted $24.36 billion in revenues, up 16 percent from $20.92 billion in 2017 and beating the consensus analyst estimate of $24.08 billion.
GenMark got clearance for an assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections, and it received clearance for a bacterial assay.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
The quantitative immunoassay measures the concentration of a novel antibiotic, plazomicin (Zemdri), using the automated clinical chemistry analyzer Beckman Coulter AU 680.
