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NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that it has completed the listing of the Ion PGM Dx next-generation sequencing system with the US Food and Drug Administration as a Class II medical device.

NEW YORK (GenomeWeb) – Epigenomics today said that its second quarter revenues rose 18 percent year over year.
The company's revenues for the three months ended June 30 reached €405,000 ($541,000), compared to €343,000 in Q2 2013.

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.

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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.