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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

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.