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FDA submission

NEW YORK (GenomeWeb News) – Affymetrix has filed its CytoScan cytogenetics platform with the US Food and Drug Administration, a company official said at the Leerink Swann Global Healthcare Conference yesterday.

NEW YORK (GenomeWeb News) – Qiagen today said that it has submitted its therascreen EGFR RGQ PCR kit to the US Food and Drug Administration as a proposed companion diagnostic for Boehringer Ingelheim's non-small cell lung cancer drug afatinib.

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NEW YORK (GenomeWeb News) – MolecularMD and Ariad Pharmaceuticals today said that MolecularMD has withdrawn its premarket approval application to the US Food and Drug Administration for its BCR-ABL T315I Mutation Test.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

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The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.

In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.

MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.

In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.