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US Food and Drug Administration, SuperArray Bioscience


The US Food and Drug Administration has granted 510(k) clearance for BD Diagnostics’ ProbeTec ET Legionella pneumophila assay, the company said last week.

The test, based on BD’s real-time nucleic acid-amplification technology called Strand Displacement Amplification, is designed to detect L. pneumophila serogroups 1 - 14 in one hour. The bacterium causes Legionnaire’s disease. BD said it is “one of several” assays under development at the company designed to detect organisms responsible for atypical pneumonia. Other assays for this indication include the Chlamydiaceae family and Mycoplasma pneumoniae, BD said.

SuperArray Bioscience has launched its real-time gene-expression assay kits for “every gene” in the human, mouse, and rat genomes, the company said last week.

These quantitative gene-expression assays are intended for genome-wide disease characterization, pathway elucidation, functional studies, and in the basic research of human disease.

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