AI-Powered Microbial Detection of Yeast and Mold

▶Revolutionary Food Safety Technology

Stericyte delivers same-day yeast and mold identification using advanced microscopy and AI-powered analysis. Validated for food safety applications, Stericyte reduces detection time by 95% compared to traditional culture methods while maintaining equivalence to FDA BAM Chapter 18 standards.

Key Differentiators: 1-2 hour presumptive results, validated across 90%+ food matrices, full traceability compliance, and seamless integration with existing quality management systems.

▶Validation Status

Stericyte has completed comprehensive scientific validation in partnership with Techcyte (AI technology) and BRS Lab Services (data generation and validation). The method is scientifically validated and ready for commercial launch, pending final regulatory accreditation.

▶Food Safety Compliance & Global Standards

Stericyte is designed to meet and exceed global food safety requirements, providing food safety professionals with confidence and regulatory compliance.

Current Compliance Standards:

• ✓FDA BAM Chapter 18 — Follows standard 1:10 dilution methodology for yeast and mold enumeration
• ✓AOAC International Guidelines — Meets requirements for microbiological method validation
• ✓ISO 21527 — Horizontal method principles for yeast and mold enumeration
• ✓FSMA Compliance — Supports preventive controls and environmental monitoring programs
• ✓HACCP Integration — Rapid results enable real-time critical control point monitoring
• ✓GFSI Recognition Ready — Validated methodology suitable for SQF, BRC, FSSC 22000 programs

Ready for New Traceability Requirements:

• ✓FDA Traceability Rule (FSMA 204) — Full digital record-keeping and data export capabilities
• ✓Direct CSV Downloads — Export complete testing data for integration with traceability systems
• ✓API Connectivity — Seamless integration with ERP, LIMS, and supply chain platforms
• ✓Lot-Level Tracking — Associate results with specific production lots for recall readiness
• ✓Electronic Record Compliance — 21 CFR Part 11 aligned digital documentation
• ✓Audit Trail — Complete chain of custody from sample receipt to final report

▶Technology Overview

• ✓AI-Powered Analysis — Deep learning algorithms detect and classify yeast and mold directly from microscope images
• ✓Automated Processing — Consistent, scalable identification eliminates subjectivity
• ✓Rapid Presumptive Results — 1-2 hour turnaround enables same-day decision making
• ✓Confirmatory Testing Available — Traditional culture methods for verification when needed

▶Matrix Compatibility — Validated Food Testing

Stericyte has been validated across representative food categories using FDA BAM standard 1:10 dilution preparation. The method demonstrates matrix independence through comprehensive testing:

▶Detectable Organisms

• ✓Yeast Species — Candida, Saccharomyces, and other yeast forms with specific identification
• ✓Mold Species — Aspergillus, Penicillium, and common mold types with species-level classification
• ✓Mixed Populations — Identification and enumeration of multiple organisms in single samples

▶Key Benefits for Food Safety Professionals

• ✓Speed — 1-2 hour results vs. 5-7 days enables rapid response to contamination events
• ✓Accuracy — Validated precision equivalent to traditional plate counting methods
• ✓Compliance — FDA BAM Chapter 18, AOAC, ISO 21527, and FSMA 204 compliant
• ✓Traceability — CSV export and API connectivity for seamless QMS integration
• ✓Cost-Effective — Competitive pricing at $16.25/swab with faster turnaround
• ✓Versatility — Works across 90%+ food products with standard preparation

▶Target Industries

• ✓Food Safety — Rapid detection for food production and processing facilities
• ✓Cannabis Industry — Pre-harvest and post-harvest contamination screening
• ✓Pharmaceutical — Clean room monitoring and product testing
• ✓Agriculture — Greenhouse and cultivation facility monitoring
• ✓Beverage Production — Brewing, wine production, and beverage manufacturing
• ✓Research Laboratories — Academic and commercial research applications

▶Data Integration & Export Capabilities

Built for seamless integration with your existing quality management systems and traceability platforms.

• ✓CSV Export — Direct download of complete testing data including sample IDs, lot numbers, test dates, organism counts, and results
• ✓API Connectivity — RESTful API endpoints for real-time data integration with ERP, LIMS, and supply chain management systems
• ✓Batch Processing — Upload and process multiple samples simultaneously with bulk data export
• ✓Custom Formatting — Configure export templates to match your internal data requirements
• ✓Secure Data Transfer — Industry-standard encryption for all data transmissions
• ✓Cloud Storage Integration — Optional automatic backup to your preferred cloud storage provider
• ✓Traceability Ready — All exports include complete metadata for FSMA 204 compliance

▶Pre-Launch Program Benefits

• ✓Introductory pricing at $16.25 per swab (Canada & USA)
• ✓Priority access to validated technology and same-day results
• ✓Full CSV export and API connectivity included
• ✓Direct communication with development team
• ✓Matrix compatibility consultation included
• ✓Early adopter recognition
• ✓Access to comprehensive validation documentation
• ✓Traceability system integration support