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In Brief This Week: Agilent, Bruker; NeoGenomics; Atossa Genetics

NEW YORK (GenomeWeb) – Agilent Technologies and Bruker this week said they have reached an agreement to exchange information for the development of instrument drivers for each other's gas chromatographs. The development of the drivers will allow the companies' GC systems to be interfaced and controlled by either Agilent's OpenLAB Chromatography Data System or Bruker's Compass CDS. The firms anticipate making the drivers available by the end of the year.


NeoGenomics raised its revenue guidance for the second quarter to a new range of $20 million to $20.5 million from a previous range of $18.8 million to $19.3 million. The earnings-per-share guidance was reaffirmed at a range of break-even to $.01.


Atossa Genetics has received registration certificates for ISO 13485:2003 "Medical devices — Quality management systems — Requirements for regulatory purposes"; EN ISO 13485:2012 and AC 2012; and ISO 9001:2008 "Quality management systems – Requirements." ISO 13485:2003 is the most recent iteration of ISO 13485, a standard for establishing quality management systems for the design, development, production, and manufacturing of medical devices.

The "EN" designation signifies that the European Union has accepted this standard and is a precursor to receiving certification under the European Medical Device Directives, Annex II. Atossa said it expects the EU certification to be completed in the coming weeks.

ISO 9001:2008 specifies requirements for a quality management system in which an organization demonstrates its ability to provide products that meet customer as well as statutory and regulatory requirements.


In Brief This Week is a Friday column containing news items that our readers may have missed during the week.

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