Medical Device Link.

TRENDS & PERSPECTIVES

• Integrated DNA Technologies Inc. (Coralville, IA) obtained from Applied Biosystems Inc. (Foster City, CA) a license to sell dual-labeled probes for use in the 5’ nuclease process. The license includes rights under several probe composition and methods patents.
  
  
• Roche Diagnostics (Basel, Switzerland) and Exiqon A/S (Vedbaek, Denmark), a provider of high-value gene expression analysis products, entered into a license agreement for the use of SYBR Green reagents in PCR. Under the terms of the agreement, Exiqon obtained from Roche a nonexclusive license to use SYBR Green I in real-time PCR.
  
  
• Ikonisys (New Haven, CT) received clearance from FDA for its oncoFish her2 test. The oncoFish her2 is a fully automated microscopy application for the determination of HER2 status in human breast cancer specimens processed with Abbott’s PathVysion Her2 DNA probe kit.
  
  
• OraSure Technologies Inc. (Bethlehem, PA) submitted a premarket approval (PMA) application to FDA for a rapid test for antibodies to the hepatitis C virus (HCV) utilizing the OraQuick technology platform. If approved, the OraQuick HCV test is expected to be the first rapid HCV test approved by FDA for use in the United States.
  
  
• InteRNA Technologies BV (Bilthoven, The Netherlands) and VU University Medical Center (Amsterdam) agreed to develop microRNA (miRNA)-based diagnostics and therapeutics for cancer. InteRNA will apply its lentiviral-based miRNA overexpression library in multiparametric, high-throughput screening assays to identify the biological role of individual miRNAs.
  
  
• SeraCare Life Sciences Inc. (Milford, MA) launched its genetic controls business with the introduction of two new products. Initial products launched included Accurun 601 controls for diagnostic testing of warfarin sensitivity and Accurun 610 controls for thrombophilia testing.
  
  
• Sequenom Inc. (San Diego) licensed from Xenomics Inc. (New York City) exclusive rights to patents for prenatal research and diagnostic products developed using fetal nucleic acids found in maternal urine. The license provides Sequenom with exclusive global rights to use transrenal fetal nucleic acids in maternal urine for noninvasive prenatal diagnostics and analysis.