Medical Device Link.

TRENDS & PERSPECTIVES

• Randox Laboratories (Crumlin, UK) has opened a diagnostic manufacturing and R&D facility in Dungloe, Co. Donegal, Ireland. Supported by Udaras na Gaeltachta (Na Forbacha, Co. Galway, Ireland), the facility will create 135 new jobs over the next three years and allow the expansion of engineering and manufacturing of products developed outside Northern Ireland.
  
  
• Eurogentec (Seraing, Belgium) opened a new GMP manufacturing facility for IVD oligonucleotides in Liege, Belgium. To meet the rapidly growing IVD demand, the new facility and quality management systems are fully compliant with the ISO 13485:2003 quality standard and FDA 21 CFR 820, including a strict card key access, airlock pass-through, and gowning policies for all employees.
  
  
• Pathwork Diagnostics Inc. (Sunnyvale, CA) announced that Stanford University School of Medicine has initiated an investigational study of the Pathwork Tissue of Origin Test. The study will evaluate the test’s ability to influence cancer diagnosis for patients with hard-to-identify tumors.
  
  
• Donal Quinn has been appointed new head of the diagnostics division of Siemens Healthcare Sector (Erlangen, Germany). Succeeding Jim Reid-Anderson, who became the new CEO of Siemens Healthcare, Quinn has previously served as executive vice president and chief customer officer of the diagnostics division since November 2007.
  
  
• The molecular diagnostic branch of the Ministry of Health and Long-Term Care (Ontario, Canada) is reporting positive results from public screenings for respiratory virus and pneumobacter detection using the Seeplex respiratory diagnostic test by Seegene (Rockville, MD). Seeplex is the only diagnostic capable of simultaneously detecting the most prevalent respiratory infections in a single test, including 11 respiratory RNA viruses, 2 DNA viruses, and 5 pneumonia bacteria.
  
  
• QIAGEN (Venlo, The Netherlands) and BioHelix (Beverly, MA) have entered into a nonexclusive worldwide license and supply agreement for BioHelix’s proprietary Helicase Dependent Amplification technology (HDA). Used to detect and analyze biological target molecules by amplifying target genetic information, HDA has shown development potential for portable DNA diagnostic devices to be used in the field or at point-of-care facilities.