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Quidel Gets FDA OK for Flu Assay on Cepheid System

NEW YORK (GenomeWeb News) – Quidel said today that it has received 510(k) clearance from the US Food and Drug Administration for its Quidel Molecular Influenza A+B assay for use with the Cepheid SmartCycler PCR system.

Quidel received FDA clearance for the same assay in December for use on Life Technologies' ABI 7500 Fast Dx thermal cycler.

Quidel launched the Influenza A+B assay in Europe for use with both the SmartCycler and 7500 Fast in August after receiving the CE-IVD Mark.

The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. The kits include "unique features that provide for simple transport and storage, ease of use, an attractive workflow, a short time to result, and other benefits that favorably affect diagnostic test outcome," the San Diego-based company said in a statement.

The Scan

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.