NEW YORK (360Dx) – Siemens Healthineers, Roche Diagnostics, BioMérieux, and Danaher's Cepheid were among the companies that received US Food and Drug Administration clearances in July for their in vitro diagnostic tests, according to the FDA website.
Siemens Healthineers received regulatory clearances for several assays, including its Advia Centaur CMV IgG assay running on the Advia Centaur XP system to detect IgG antibodies to cytomegalovirus in human pediatric and adult serum and plasma. Also, the agency cleared the Advia Centaur CMV IgG quality control material, which is used to monitor the performance of the ADVIA Centaur CMV IgG assay.
For some time, US in vitro diagnostics industry participants have been anticipating the clearance of additional high sensitivity troponin assays. In July, Siemens got the go-ahead for its high-sensitivity troponin I assays for use on its Atellica IM and Advia Centaur XP/XPT immunoassay analyzers and to aid in the early diagnosis of myocardial infarctions, or heart attacks.
Adding to the range of sepsis procalcitonin assays the FDA has cleared in the past few years, it cleared the Atellica IM BRAHMS PCT Assay for sepsis assessment, assigning mortality risk, and antibiotic therapy decision-making in the emergency department and intensive care unit.
Siemens also received clearance for its 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.
Clinicians use measurement of hemoglobin A1c to diagnose diabetes mellitus and monitor long-term blood glucose control, and to identify patients at risk for developing diabetes mellitus.
Diagnosis of diabetes mellitus was the subject of the FDA's clearance of Sekisui Diagnostics' Sekure HbA1c assay. The assay was also cleared to monitor the long-term blood glucose control of patients with diabetes mellitus.
BioMérieux's ETest received clearance for determination of antimicrobial susceptibility of non-fastidious gram-negative and gram-positive aerobic bacteria, such as enterobacteriaceae, pseudomonas, staphylococcus, and enterococcus species; andfastidious bacteria, such asanaerobes, N. gonorrhoeae, S. pneumoniae, and streptococcus and haemophilus species.
The firm also received clearance for Chromid Carba agar, a selective and differential chromogenic medium for the detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization.
In the area of respiratory infection, Cepheid received clearance for a multiplex nucleic acid assay that detects and differentiates influenza A, influenza B, and respiratory syncytial virus using real-time RT-PCR. The Xpert Flu+RSV Xpress Assay uses nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection.
To detect nucleic acids isolated from patients suspected of having respiratory tract infection, the FDA cleared Quidel's Solana Bordetella Complete Assay for detection of Bordetella pertussis and Bordetella parapertussis.
Thermo Fisher Scientific's Phadia received clearance 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.
Diagenode received clearance for the use of the Panther Fusion GBS Assay, which uses real-time PCR for detection of group B streptococcus DNA from broth cultures of vaginal or rectal swabs taken from antepartum women, following 18 to 24 hours of swab incubation. The test is performed on the Hologic Panther Fusion system to aid in determining the GBS colonization status of antepartum women.
PerkinElmer received 510(k) clearance for two assays developed by its Euroimmun subsidiary for the screening and diagnosis of anti-neutrophil cytoplasmic antibodies-associated vasculitis.
Healthy.io got clearance for its smartphone-enabled urinalysis kit called Dip.io.
The FDA granted 510(k) clearance to a high-throughput molecular diagnostics platform and Group B Strep assay from Ann Arbor, Michigan-based NeuMoDx Molecular.
In July, the FDA cleared Roche's Elecsys BRAHMS PCT assay for an expanded use to aid in antibiotic therapy decision-making.
Further, the FDA 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.
The agency approved a drug developed by Agios Pharmaceuticals for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with IDH1 mutations, as well as a companion diagnostic test developed by Abbott Laboratories.
Ceres Nanosciences received Breakthrough Device designation for its Lyme disease test.