Medical Device Link.

TRENDS & PERSPECTIVES

• AMDL (Tustin, CA) has received FDA clearance to market its colorectal cancer (CRC) monitor, DR-70 (FDP). The blood test has the ability to monitor the progression and recurrence of CRC postsurgery and is the first CRC monitor to gain FDA clearance since 1982.
  
  
• Nanogen Inc. (San Diego), in partnership with the Medical College of Wisconsin and HandyLab Inc. (Ann Arbor, MI), has been awarded a $10.4 million, two-year contract from CDC to develop a multianalyte molecular diagnostic assay for influenza. The test will be significantly more sensitive and virus-specific than current rapid flu tests, while decreasing the time to result.
  
  
• Gen-Probe (San Diego) has nonexclusively licensed Xceed Molecular’s (Wellesley, MA) Flow-Thru Chip technology to develop next-generation multiplexed molecular diagnostics. The agreement also provides Gen-Probe with Xceed’s Ziplex automated gene expression system.
  
  
• bioMérieux (Marcy l’Etoile, France) has acquired AB Biodisk (Stockholm), a privately held IVD company, in its fourth acquisition in two years. The company’s high-medical-value offering, Etest, will complement bioMérieux’s Vitek range for antibiotic susceptibility testing.
  
  
• Prodesse Inc. (Milwaukee) has begun clinical trials for ProParaflu+, a multiplex real-time PCR assay, that will detect and differentiate parainfluenza viruses 1, 2, and 3, which are the leading causes of respiratory illness in children. While current detection methods may take several days for deterministic results, the new product will yield answers within hours.
  
  
• Johnson & Johnson Nordic AB (Sollentuna, Sweden) has acquired privately held Amic (Uppsala, Sweden), a developer of IVD technologies for use in point-of-care and near-patient settings. The transaction will provide Ortho-Clinical Diagnostics Inc. (Rochester, NY), a Johnson & Johnson company, with access to this rapidly growing area of diagnostics.
  
  
• Qiagen Gaithersburg Inc. (Gaithersburg, MD) has filed an appeal with the U.S. Court of Appeals in the Federal Circuit to reinstate its patent infringement lawsuit against Third Wave Technologies Inc. (Madison, WI) for its digene HPV test. The patent suit was originally dismissed by the U.S. District Court when Third Wave’s antitrust counterclaim suit was dismissed.