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FDA submission

NEW YORK (GenomeWeb) –The US Food and Drug Administration has accepted for review 23andMe's 510(k) application for a single-condition health report, the consumer genomics firm informed customers.

NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that its San Jose, Calif., facility has been registered with the US Food and Drug Administration as a medical device establishment.

NEW YORK (GenomeWeb) – T2 Biosystems today said that it has filed a 510(k) premarket submission with the US Food and Drug Administration for its T2Dx system and T2Candida assay.

NEW YORK (GenomeWeb News) – Qiagen said after the close of the market on Wednesday that its fourth quarter revenues increased 5 percent year over year at constant exchange rates.

NEW YORK (GenomeWeb News) – Luminex announced after the close of the market Monday that the US Food and Drug Administration has cleared for marketing a new version of its xTAG CYP2D6 kit.

NEW YORK (GenomeWeb News) – Roche today said that it has submitted a Premarket Approval supplement to the US Food and Drug Administration seeking the addition of a cervical cancer primary screening indication for its cobas HPV Test.

NEW YORK (GenomeWeb News) – Exact Sciences has submitted the third and final module of its premarket approval application to the US Food and Drug Administration for its Cologuard colorectal cancer screening test, the company said today.

NEW YORK (GenomeWeb News) – Epigenomics today said that the US Food and Drug Administration has accepted its premarket approval application for its colorectal cancer test and has granted the application priority review status.

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.

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The American Prospect writes that the pilot program to test the DNA of migrants could lead to more family separations.

An international commission is to develop a report on how researchers, clinicians, and regulators should evaluate the clinical applications of human germline genome editing.

The US Department of Agriculture presents a new blueprint for animal genomic research.

In Genome Research this week: repetitive element deletion linked to altered methylation and more in form of muscular dystrophy; human contamination in draft bacterial and archaeal genomes; and more.