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Quidel Gets FDA OK for Adenovirus MDx

NEW YORK (GenomeWeb) — Quidel said on Monday that it has received 510(k) clearance from the US Food and Drug Administration to market its Lyra Adenovirus Assay, a real-time PCR test for the qualitative detection of human adenovirus viral DNA from nasal and nasopharyngeal swabs.

The new test is part of Quidel's Lyra brand of ready-to-use PCR reagent kits designed for use on a laboratory's existing thermal cycler. Features of the kits include a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage.

The San Diego-based clinical diagnostics firm now offers FDA-cleared Lyra assays for a dozen different infectious agents including eight such tests for respiratory disease (Streptococcus B, Strep C+G, influenza A, influenza B, human metapneumovirus, respiratory syncytial virus, and adenovirus); as well as assays for herpes simplex viruses 1 and 2, varicella zoster virus, and Clostridium difficile.

The Scan

Study Points to Tuberculosis Protection by Gaucher Disease Mutation

A mutation linked to Gaucher disease in the Ashkenazi Jewish population appears to boost Mycobacterium tuberculosis resistance in a zebrafish model of the lysosomal storage condition, a new PNAS study finds.

SpliceVault Portal Provides Look at RNA Splicing Changes Linked to Genetic Variants

The portal, described in Nature Genetics, houses variant-related messenger RNA splicing insights drawn from RNA sequencing data in nearly 335,700 samples — a set known as the 300K-RNA resource.

Automated Sequencing Pipeline Appears to Allow Rapid SARS-CoV-2 Lineage Detection in Nevada Study

Researchers in the Journal of Molecular Diagnostics describe and assess a Clear Labs Dx automated workflow, sequencing, and bioinformatic analysis method for quickly identifying SARS-CoV-2 lineages.

UK Team Presents Genetic, Epigenetic Sequencing Method

Using enzymatic DNA preparation steps, researchers in Nature Biotechnology develop a strategy for sequencing DNA, along with 5-methylcytosine and 5-hydroxymethylcytosine, on existing sequencers.