True Diagnostics creates powerful and simple solutions for the $46 billion and growing point-of-care, food safety, verification and animal health markets which are fast, portable, economical and risk-stratifying. With a small sample (e.g.,a finger prick of blood, a small urine or saliva sample or a surface wipe), the TrueDX Platform conducts qualitative and quantitative tests and provides laboratory quality results in minutes.
The TrueDX PlatformTM conducts qualitative and quantitative tests for life-threatening, quality of life and environmental conditions and provides laboratory quality results in minutes.
Performance & Growth
Countries around the world face mounting challenges in healthcare ranging from escalating costs and increased demand for patient access. Point-of-Care (POC) has become a critical component of the paradigm shift in providing affordable healthcare. In four years, it is expected the global market for point-of-care testing will reach $18.7 billion dollars. Our focus is on delivering a single diagnostic platform developed and validated through substantiated and reproducible test principles that employs new analytical methods to enable and realize this market opportunity.
Research & Development
Our partners and clients come to us for our experience and technical know-how. We have over 30 years of expertise in developing, manufacturing, and commercializing immunoassays and molecular diagnostics. Our track record and proprietary library of reagents and materials allow us to deliver solutions to address:
- Optimized Precision
- Optimized Stability
- Sample Preparation
- Antibody Screening/Validation/Production (Monoclonal/Polyclonal/Peptides)
- Colorimetric Detection
- Fluorescence Detection
- Electrochemical Detection
Our development processes are performed under ISO 13485 and are fully design controlled and phased as outlined below.
Our Discovery & Development Capabilities
– Reagent Production (Monoclonal/Polyclonal)
– Reagent Selection
– Prototype Reader
– Prototype Cassette
– Prototype Assay
– Finalized Assay
– Finalized Cassette
– Finalized Reader
– Pre-Clinical Studies
– Method Comparison
– CLIA Studies
Manufacturing & Support
True Diagnostics provides contract manufacturing services in a cGMP, FDA Licensed and ISO 13485 certified facility. Our company also provides regulatory expertise and consulting for the FDA Clearance and Support of medical devices.