Risk Analysis
  • Regulatory compliance
  • 510(k): Existence of a predicate device (Veridex) will reduce time and risk for
  • regulatory approval.
  • This is a monitoring test, not a primary diagnostic
  • Technology
  • Patents: USA (Number 7,695,966 Avril 2010) et PCT WO/2008/155398).
  • Technology based on Immunochemistry including microfluidic chips, that are
    based on immuno-chemistry may lower the rate of detection, can be time
    consuming and are very expensive to run.
  • Market
  • Existing reimbursement in USA: CPT Codes (88346, 88361, 88313) soon in EU
  • Canopus Bioscience
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