Medical Device Link.

TRENDS & PERSPECTIVES

• CombiMatrix Corp. (Mukilteo, WA) announced that the validation study performed by its wholly owned subsidiary, Combimatrix Molecular Diagnostics (Irvine, CA), on its HerScan breast-cancer test is available as an advance online publication. The study appears in the official journal of the United States and Canadian Academy of Pathology, Modern Pathology. HerScan is an array-based test designed to provide an accurate and objective enumeration of the Her2 gene locus against the template of the whole genome.
  
  
• Axela Inc. (Toronto) announced two new agreements designed to expand its suite of biomarker analysis and assay development tools. Recent agreements with Proteome Sciences plc and Micromedics provide access to proprietary biomarkers for use on the DotLab Biomarker Analysis Platform. These assays will initially be offered for research use only as PanelPlus multiplex reagents for the DotLab System. Based on unique optics technology, the DotLab System allows reagent qualification, assay development, and routine quantitative analysis to be performed on one platform.
  
  
• Qiagen N.V. (Venlo, The Netherlands) announced that it signed an agreement to transfer distribution rights for the Olerup SSP product line and the related assets to Olerup International AB, a subsidiary of LinkMed, a Swedish venture capital company. The Olerup SSP product line includes molecular-transplantation testing products used for DNA HLA typing. Quiagen will retain rights to all Olerup SSP assays for applications outside transplantation testing, such as in personalized medicine, and Qiagen will transfer all assets related to its Olerup SSP HLA sales infrastructure to LinkMed, including office infrastructure in Austria.
  
  
• BioPorto Diagnostics (Copenhagen) announced the successful development of a test that can diagnose acute kidney injury. Existing methods of determining injury do not provide useful information about the state of the patient until one to three days after an injury has occurred, according to BioPorto spokespersons. In contrast, the NGAL test will reveal the occurrence of kidney injury within a few hours. The test is designed to be used on existing apparatus. It was developed in collaboration with one of the world’s leading manufacturers of diagnostic tests and is currently being prepared for production.