The FDA also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
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.
The business is part of Thermo Fisher's Specialty Diagnostics segment and generates about $350 million in revenues annually.
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.
A lack of attractive targets, high valuations, and a more attractive IPO market contributed to a 45 percent year-over-year decline in M&A.
The year saw the launch of high-profile platforms as well as efforts by a number of parties to streamline mass spec technologies for the clinic.
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.