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

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