Medical Device Link.

TRENDS & PERSPECTIVES

• FDA reported that Qiagen (Venlo, The Netherlands) inappropriately marketed six of its products as analyte-specific reagents and must apply for new FDA approvals. Qiagen marketed the products as being able to detect more than one chemical substance, and directly sold them to clinical laboratories rather than as parts to contribute to finished devices.
  
  
• Abbott Laboratories (Abbott Park, IL) entered into an exclusive distribution agreement with Verax Biomedical Inc. (Worcester, MA). Under the terms of the agreement, Abbott receives worldwide rights to market and distribute the Verax Platelet PGD Test, which is currently being evaluated in clinical trials.
  
  
• Grant Life Sciences (Los Angeles) is exploring an expanded partnership with Diagnostic Technologies Ltd. (DTL; Yokneam, Israel). The original proposed association was to have been a definitive licensing agreement. An extension of the memorandum of understanding between Grant and DTL was made necessary because DTL’s business activities were significantly hindered as a result of the 2006 Israel/ Lebanon conflict.
  
  
• Meridian Bioscience (Cincinnati) signed a license agreement with Eiken Chemical Co. (Tokyo) for its loop-mediated isothermal amplification (LAMP) technology. This license agreement allows Meridian to apply the LAMP technology for the detection of infectious diseases in the United States and 18 other geographic markets.