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FDA submission

NEW YORK (GenomeWeb News) – Gen-Probe has submitted an application with the US Food and Drug Administration for regulatory approval of a genotyping assay for human papillomavirus.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Idaho Technology said late on Monday that it is seeking US regulatory approval for five additional pathogens for its FilmArray Respiratory Panel.

By Tony Fong
NEW YORK (GenomeWeb News) – Having demonstrated the utility of its technology, molecular diagnostics firm Sequenta will focus on clinical validation of its technology in 2012 with an expected launch of its first product next year.

By Tony Fong
NEW YORK (GenomeWeb News) – Molecular diagnostics firm T2 Biosystems is set to begin a clinical trial for its first assay targeting Candida fungal infections as it prepares to seek regulatory approval in the US next year.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – GenMark Diagnostics today said that it has filed with the US Food and Drug Administration for 510(k) clearance of its Respiratory Viral Panel.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – German cancer molecular diagnostics firm Epigenomics today reported revenues in the third quarter fell 29 percent year over year while its net loss increased by 60 percent.

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A New Zealand minister says the country's genetic modification laws need to be re-examined to help combat climate change, the New Zealand Herald reports.

A new analysis finds some cancers receive more nonprofit dollars than others.

An Australian mother's conviction in the deaths of her children may be re-examined after finding that two of the children carried a cardiac arrhythmia-linked gene variant.

In Science this week: comparative analysis of sex differences in mammal gene expression, and more.