SterileTest Single-Use Verification Array

Download SterileTest Single-Use Verification Array Documentation (pdf)

SterileTest Single-Use Verification Array biological indicators provide a fast, easy-to-use, and cost-effective method for validating the sterilization of medical devices, irrespective of the sterilization method deployed.

SterileTest Single-Use Verification Array Utilizes Existing Equipment

SterileTest Verification diagram

Intellectual Property

  • U.S. patent issued (April 2019), foreign patent pending

Challenges in Validating Sterility

  • Most disinfection and sterilizing systems only monitor parameters related to sterility level
  • Rarely are validation methods available to assure the disinfection or sterility of medical devices

Broadly-applied Sterility Validation

  • Simple, rapid, highly-accurate, and patent pending test methods validate virtually every medically-critical bacterial and fungal pathogen
  • Assesses a range of pathogen families
    • Bacillus
    • Clostridium
    • Mycobacterium
    • Staphylococcus
    • Pseudomonas
    • Trichophyton
    • Candida
  • Used in standard laboratory equipment

Application Areas

  • Automatic Endoscope Reprocessing
  • Surgical device sterilization
  • Surgical system sterilization
  • Reprocessing of single-use devices

Research Partnering Program

  • Immediate:
    • Develop materials and methodologies for applying the technology in a robust product configuration.
    • Initial market targets are C.diff, MRSA and CRE (vegetative bacteria) with additional targets to include full range of pathogens including prions, spores, additional vegetative bacteria and fungus.
  • Long-term:
    • Development of combination tests with multiple genera on a single protein array sample.
    • Have multiple formats for different sterilization and disinfection processes.
    • Develop test kits for approval and market launch.
  • The Company is in the process of establishing collaboration with US and European research groups to drive product