Roche, Siemens Healthineers, Becton Dickinson, Cepheid, and DiaSorin are among the companies that got approval for tests from the US Food and Drug Administration (FDA) in March 2018.
Roche received FDA clearance for its Cobas CT/NG assay run on its Cobas 6800 and 8800 systems. This assay has been validated for use with anorectal and oropharyngeal swab specimens, enabling laboratories to test for infections in extragenital specimens with increased confidence. It also 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. Roche also received clearance for its Cobas m 511 hematology analyzer that enables labs to prepare, stain, and analyze blood smears for abnormal results thorough a single process. The analyzer combines a digital morphology analyzer, cell counter and classifier into one streamlined instrument preparing, staining and analyzing microscopy blood slides.
An ISO 13485 certified medical device manufacturer, Diazyme received approval for its latex particle enhanced immunoturbidimetric assay for the determination of lipoprotein (a). This assay is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations when used in conjunction with clinical evaluation.
The FDA also cleared Becton Dickinson‘s BD Veritor System that provides objective, lab-quality immunoassay test results within minutes for healthcare providers and laboratorians in physician offices, clinics, hospitals and IDNs.
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. Designed to address common clinical laboratory challenges, the Atellica® Solution integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology, allowing labs to focus on achieving better outcomes.
Other tests that received FDA approval in March include DiaSorin's Simplexa HSV 1 & 2 Direct assay and Simplexa HSV 1 & 2 Positive Control Pack, Cepheid's Xpert CT/NG Assay, Guangzhou Wondfo Biotech's Preview Digital Pregnancy Test, Runbio BioTech's David Home Pregnancy Test Cassette, Aesku Diagnostics' Aeskuslides ANCA indirect immunofluorescence assay, Oxford Immunotec's Imugen arrayed fluorescent immunoassay, Quidel's Sofia Lyme FIA test, Phadia's Elia PR3s immunoassay, Immco Diagnostics' ImmuLisa Enhanced RNA POL III Antibody ELISA, and Hardy Diagnostics' Granada Medium.