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Roche Diagnostics, Becton Dickinson, Others Receive FDA Clearances in September

NEW YORK (360Dx) – Roche Diagnostics, Abbott, Siemens Healthineers, and Becton Dickinson were among the companies that received US Food and Drug Administration clearances in September for their in vitro diagnostic tests, according to the FDA website.

The FDA cleared Becton Dickinson's BD Phoenix Automated Microbiology System and its BD Phoenix CPO Detect – GN test. The automated microbiology system is used for rapid identification and determination of antimicrobial susceptibility of gram-negative Enterobacteriaceae and non-Enterobacteriaceae bacteria using minimal inhibitory concentration.

BD Phoenix CPO Detect is a confirmatory test that uses a growth-based algorithm intended to phenotypically detect carbapenemase-production in Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii on gram-negative ID/AST or AST-only Phoenix panels.

Meantime, the FDA cleared Roche Diagnostics' Elecsys FT4 III Assay for the measurement of free thyroxine used to diagnose and treat thyroid disease. The electrochemiluminescence immunoassay runs on the Roche Cobas e 411 immunoassay analyzer.

Siemens Healthineers received clearance for its Innovance Free PS Ag assay for detecting free protein S antigen in human plasma collected from venous blood samples and running on the Sysmex CS-5100 analyzer. The immunoturbidimetric assay is used to diagnose patients that have a protein S deficiency, a disorder of blood clotting. Its performance has not been established in neonate and pediatric patient populations, the FDA said.

Abbott received clearance for an assay that measures magnesium in human serum, plasma, or urine, running on the firm's Architect c8000 clinical chemistry system. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia, or abnormally low plasma levels of magnesium, and of hypermagnesemia, or abnormally high plasma levels of magnesium.

Skyla received clearance for its Hi Hemoglobin A1c System, consisting of its Hi Analyzer and Hi Hemoglobin A1c Reagent Kit, for the measurement of the percent concentration of glycated hemoglobin (HbA1c) in venous and finger-stick capillary whole blood. The system monitors long-term glycemic control in patients previously diagnosed with diabetes mellitus. The system can be used in the clinical laboratory and at the point-of-care, but it is not cleared for screening or diagnosis of diabetes.

Applied BioCode received clearance for its BioCode Gastrointestinal Pathogen Panel, a multiplexed nucleic acid-based assay capable of detecting nucleic acids from a range of gastrointestinal microorganisms. Its results are intended to be used in conjunction with other clinical, laboratory, and epidemiological data.

Princeton BioMeditech received clearance for the BioSign Flu A+B test to detect influenza type A- and B-nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasalpharyngeal aspirate specimens obtained from patients with signs and symptoms of respiratory infection.

Also in September, the FDA approved the expanded use of Qiagen's Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic for Pfizer's Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutation.

Premier Biotech received 510(k) clearance for two additional assays for use on its OralTox oral fluid-based drugs of abuse device, while InBios International received clearance for its DENV Detect NS1 ELISA, an antigen detection assay that provides a presumptive diagnosis of dengue virus before IgM antibodies are present in a patient.