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 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.