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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.

Filed under

The Scan

Removal Inquiry

The Wall Street Journal reports that US lawmakers are seeking additional information about the request to remove SARS-CoV-2 sequence data from a database run by the National Institutes of Health.

Likely to End in Spring

Free lateral flow testing for SARS-CoV-2 may end in the UK by next spring, the head of Innova Medical Group says, according to the Financial Times.

Searching for More Codes

NPR reports that the US Department of Justice has accused an insurance and a data mining company of fraud.

Genome Biology Papers on GWAS Fine-Mapping Method, COVID-19 Susceptibility, Rheumatoid Arthritis

In Genome Biology this week: integrative fine-mapping approach, analysis of locus linked to COVID-19 susceptibility and severity, and more.