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In March, FDA Cleared Tests from Roche, Siemens, Becton Dickinson, and Others

NEW YORK (360Dx) – Roche, Siemens Healthineers, Becton Dickinson, Cepheid, and DiaSorin were among several companies receiving US Food and Drug Administration clearances for tests in March, according to the FDA website.

The agency cleared DiaSorin's Simplexa HSV 1 & 2 Direct assay running on its Liaison MDx instrument for the detection and differentiation of herpes simplex virus DNA in lesion swabs from patients with symptoms of HSV-1 or HSV-2 infection. The agency also cleared the firm's Simplexa HSV 1 & 2 Positive Control Pack as a control used with the Simplexa HSV 1 & 2 Direct kit.

Cepheid received clearance for the Xpert CT/NG Assay running on the GeneXpert instrument. The test uses PCR technology for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis or Neisseria gonorrhoeae, or both.

The FDA cleared Roche's Cobas CT/NG assay running on the firm's Cobas 6800 and 8800 systems. It uses real-time PCR for the direct detection of Chlamydia trachomatis or Neisseria gonorrhoeae, or both, and enables the diagnosis of people who are symptomatic or asymptomatic.

The firm also received clearance for its Cobas m 511 hematology testing solution. The analyzer combines a cell counter, slide maker and stainer, and a digital morphology analyzer into one integrated solution, enabling laboratories to report the complete blood count, white blood cell differential, and reticulocyte results. It also enables labs to prepare, stain, and analyze blood smears for abnormal results thorough a single process.

At least three pregnancy tests received clearances last month. Runbio BioTech received clearance for the David Home Pregnancy Test Cassette, an over-the-counter lateral flow immunoassay used for the determination of human chorionic gonadotropin in urine and to enable early detection of pregnancy. Further, the FDA granted clearance to Guangzhou Wondfo Biotech for its Preview Digital Pregnancy Test used in the detection of human chorionic gonadotropin in urine and to enable early pregnancy detection.

In the same month that it raised €4.2 billion ($5.2 billion) from an initial public offering, Siemens Healthineers received clearance for a clinical chemistry assay that enables early detection of pregnancy. The Atellica IM Total hCG human chorionic gonadotropin assay runs on Siemen's Atellica IM Analyzer.

The agency cleared a few fluorescence-based immunoassays. Aesku Diagnostics received clearance for its Aeskuslides ANCA indirect immunofluorescence assay, which employs slides coated with human neutrophil granulocyte as a substrate in detecting anti-neutrophil cytoplasmic autoantibodies in human serum. The autoantibodies are detected by using manual microscopy or the Helios automated immunofluorescence system.

The FDA approved Oxford Immunotec's Imugen arrayed fluorescent immunoassay for the detection of antibodies to Babesia microti in human plasma samples, and the Imugen nucleic acid test for the detection of B. microti DNA in human whole blood samples.

And Quidel received clearance for its Sofia Lyme FIA test to run on the Sofia 2 Fluorescent Immunoassay Analyzer.

Phadia received clearance for its Elia PR3s immunoassay for the measurement of IgG antibodies directed toward proteinase 3 in human serum and plasma and used in the diagnosis of granulomatosis with polyangiitis. Further, Phadia received clearance for its Elia MPOs immunoassay used to measure IgG antibodies directed toward myeloperoxidase in human serum and plasma and used to enable the diagnosis of microscopic polyangiitis.

The FDA cleared the firm's Elia GBM assay for the measurement of IgG antibodies to α3 chain of collagen IV in human serum and plasma and to enable the diagnosis of Goodpasture syndrome. All three immunoassays are used in conjunction with other laboratory and clinical findings and they run on the Phadia 2500/5000 instrument.

Diazyme received clearance for its latex particle enhanced immunoturbidimetric assay for the determination of lipoprotein(a), which is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations.

The FDA cleared Becton Dickinson's BD Veritor System, a rapid chromatographic immunoassay for the detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs taken from symptomatic patients, and it cleared Immco Diagnostics' ImmuLisa Enhanced RNA POL III Antibody ELISA used to detect anti-RNA POL III IgG antibodies in human serum and to enable diagnosis of systemic sclerosis.

Also receiving 510(k) clearance was Hardy Diagnostics' Granada Medium, a selective and differential agar used to detect Group B streptococcus following 18 to 24 hours of incubation of Lim broth enriched cultures of vaginal or rectal swabs taken from antepartum women.

The agency Cancer Genetics' Tissue of Origin Test that measures the degree of similarity between RNA expression patterns in a patient's formalin-fixed, paraffin-embedded tumor sample and these types of patterns in a database of fifteen tumor types.

Liofilchem received clearance for use of its MIC Test Strip, a quantitative method that determines antimicrobial susceptibility of bacteria. 

And the FDA cleared a point-of-care and a lab system from Exalenz Bioscience for detecting Helicobacter pylori bacteria in children between the ages of three and 17.

The FDA also cleared Ortho Clinical Diagnostics' Ortho Connect V2.0, its integrated and customizable middleware system, which centralizes laboratory operations and workflow across hospitals and networks and allows blood banks to manage their data through one central terminal.

Longhorn Vaccines and Diagnostics received de novo clearance for its PrimeStore Molecular Transport Medium for stabilizing microbial nucleic acids.