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Quidel

Quidel this week received 510(k) clearance from the US Food and Drug Administration for its AmpliVue C. Difficile assay.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Quidel's molecular diagnostic assay for detecting Clostridium difficile infections for sale in the US, the San Diego-based company said today.

Life Technologies has received CE IVD marking for its Applied Biosystems QuantStudio Dx platform and launched the instrument in Europe.

Quidel this week provided an update on its burgeoning molecular diagnostics pipeline, noting that it hopes to be able to gain US regulatory approval in the next few months for its CE-marked non-instrumented, isothermal amplification-based AmpliVue assay for Clostridium diffic

NEW YORK (GenomeWeb News) – Quidel said after the close of the market Tuesday that revenues in the third quarter narrowed by a fraction of 1 percent year over year, missing the consensus Wall Street estimate.

NEW YORK (GenomeWeb News) – Piper Jaffray on Thursday initiated coverage of diagnostics firm Quidel with an Overweight rating, noting the San Diego-based company's move into the molecular diagnostics space.
The investment bank has a $26 price target on Quidel's stock.

NEW YORK (GenomeWeb News) – In a nod to the growing influence of diagnostic products and services on clinical decisions, investment bank Cowen & Co. today initiated coverage of several firms operating in the molecular diagnostics and 'omics-related life science spaces.

BioHelix is developing a low-cost, handheld, real-time fluorescence detection system capable of running assays based on the company's isothermal helicase-dependent amplification technology, the company disclosed this week.

NEW YORK (GenomeWeb News) – Quidel announced late on Friday it has entered into an amended and restated $140 million, five-year senior secured facility.
Bank of America is the sole lead arranger for the facility, while US Bank National Association is the syndication agent.

This story has been updated from a previous version to include additional information about the QuantStudio Dx platform.

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Howard Hughes Medical Institute will be requiring its researchers to publish their work so it is immediately accessible to the public, ScienceInsider writes.

The Huffington Post reports that Francis Collins, the director of the US National Institutes of Health, has urged Americans to recommit to reason.

About 150 million rapid coronavirus tests purchased by the US federal government are to be distributed to nursing homes, colleges, and the states, according to the New York Times.

In Nature this week: multi-omic analysis of Alzheimer's disease brain samples, de novo assembly of a diploid potato, and more.