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The company is recalling cards for cefoxitin and oxacillin after it determined they can provide false results for some strains of MRSA, the FDA said.
Siemens Healthineers received FDA clearances for several assays, including separate allowances for tests using hemoglobin A1c, troponin I, and procalcitonin biomarkers.
The assay combines antibody enrichment with MALDI mass spec to measure isoforms of transferrin, a protein biomarker used to track alcohol consumption.
The firm attributed growth to a diversified geographic footprint and comprehensive offerings based on three key in vitro diagnostics technologies.
The 20-gene assay, which BioMérieux will develop on the BioFire FilmArray platform, distinguishes active TB from latent TB, viral, and bacterial infections.
Clinicians were surprised by a recent NEJM study that found that using procalcitonin assays did not reduce the use of antibiotics.
UPitt researchers found that using an FDA-cleared procalcitonin assay did not significantly change the use of antibiotics for patients suspected of having lower respiratory tract infections.
Sales were driven by a strong flu season and growth in Asia-Pacific business.
Astute is the maker of Nephrocheck, an immunoassay test for biomarkers predicting acute kidney injury.
Using an immunoassay as an initial screening tool saved approximately $36,000 over multiplex PCR panel use alone when performed in a period of high flu prevalence.