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FDA submission

NEW YORK (GenomeWeb News) – Exact Sciences said after the close of the market on Monday that it submitted the first module of its premarket approval submission to the US Food and Drug Administration for its Cologuard molecular diagnostic test.

NEW YORK (GenomeWeb News) – German molecular diagnostics company Curetis said today it anticipates filing a 510(k) submission with the US Food and Drug Administration for its Unyvero System in 2014.

NEW YORK (GenomeWeb News) – Fluxion Biosciences said today it has registered its South San Francisco, Calif., facility as a medical device facility with the US Food and Drug Administration.

NEW YORK (GenomeWeb News) – MolecularMD and Ariad Pharmaceuticals today said that MolecularMD has withdrawn its premarket approval application to the US Food and Drug Administration for its BCR-ABL T315I Mutation Test.

NEW YORK (GenomeWeb News) – Idaho Technology today said that it anticipates commercially launching its blood culture ID and gastrointestinal panels by early 2014.

NEW YORK (GenomeWeb News) – MolecularMD has submitted a Premarket Approval application with the US Food and Drug Administration for a companion diagnostic test to leukemia drug ponatinib.

NEW YORK (GenomeWeb News) – 23andMe today announced that it has started the process for regulatory clearance of its Personal Genome Service.

NEW YORK (GenomeWeb News) – The US Senate yesterday passed a bill that will reauthorize the Food and Drug Administration's medical device user fee program, enabling the agency to collect an additional $308 million over five years to fund its regulatory activities and to take steps to modernize it

NEW YORK (GenomeWeb News) – Dako has signed an agreement with Genentech to partner on the regulatory submission of companion diagnostic tests for a breast cancer drug.

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.

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In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.