The US Food and Drug Administration (FDA) have cleared in vitro diagnostic tests from Siemens Healthineers, Roche Diagnostics, BioMérieux, Danaher's Cepheid, and other companies.
Siemens received clearances for its Advia Centaur CMV IgG assay that can be used on the Advia Centaur XP system to detect IgG antibodies to cytomegalovirus in human pediatric and adult serum and plasma. Siemens also received FDA clearance for the following:
- Advia Centaur CMV IgG quality control material, which is used to monitor the performance of the ADVIA Centaur CMV IgG assay
- High-sensitivity troponin I assays for use on its Atellica IM and Advia Centaur XP/XPT immunoassay analyzers, which helps in early diagnosis of myocardial infarctions, or heart attacks
- Atellica IM BRAHMS PCT Assay for sepsis assessment, assigning mortality risk, and antibiotic therapy decision-making in the emergency department and intensive care unit
- Dimension Hemoglobin A1c turbidimetric inhibition assay to determine the percentage and mmol/mol measurements of HbA1c in venous whole blood and for use on the firm's Dimension clinical chemistry system
Thermo Fisher Scientific‘s Phadia was approved for use of its EliA M2 Immunoassay on the Phadia 2500/5000 for the semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma, and to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other lab and clinical findings.
The FDA cleared Roche's Elecsys BRAHMS PCT assay for an expanded use to aid in antibiotic therapy decision-making. The FDA also approved Roche's Cobas HPV Test as a first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid.
Other tests that received FDA clearance in July include Abbott Laboratories' companion diagnostic test, Sekisui Diagnostics' Sekure HbA1c assay, Diagenode's Panther Fusion GBS Assay, PerkinElmer's two assays developed by its Euroimmun subsidiary, Cepheid's multiplex Xpert Flu+RSV Xpress Assay, BioMérieux's ETest and Chromid Carba agar, Quidel's Solana Bordetella Complete Assay, Ann Arbor's high-throughput molecular diagnostics platform and Group B Strep assay, Healthy.io's smartphone-enabled urinalysis kit called Dip.io. Ceres Nanosciences' Lyme disease test received Breakthrough Device designation.