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NEW YORK (GenomeWeb) – Quidel has received 510(k) clearance from the US Food and Drug Administration for a molecular assay for the qualitative detection of Clostridium difficile.

The test runs on the firm's Solana platform and generates results in about 35 minutes from unformed stool specimens without a nucleic acid extraction step. The platform can process up to 12 different assays or patient samples in each batched run and uses the firm's helicase-dependent amplification technology, which is also the core technology of Quidel's AmpliVue molecular product line.

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