True Diagnostics, Inc.
True Diagnostics develops and manufactures innovative point-of-care diagnostic tests and devices, utilizing proprietary platforms like TrueDX™ to provide rapid, lab-quality results in minutes. The company focuses on making diagnostics accessible, affordable, and easy to use in various settings including remote and emerging markets, with applications spanning from healthcare to food safety and animal health. The company collaborates with pharmaceutical, biotech, academic, and diagnostic partners to drive the future of personalized medicine using the TrueDX Platform™.
Industries
Nr. of Employees
small (1-50)
True Diagnostics, Inc.
Carlsbad, California, United States, North America
Products
Disposable/low‑cost portable quantitative reader
Small‑format disposable or low‑cost reader that measures lateral‑flow cassette signals and displays quantitative or qualitative results on‑device; includes LED sensor and wired/wireless output options.
Portable touchscreen quantitative reader (CMOS image sensor)
Portable reader using a CMOS image sensor and touchscreen interface for quantitative lateral‑flow analysis with multiple connectivity options (USB, Wi‑Fi, Bluetooth).
Cassette‑format lateral‑flow assays for multiple clinical analytes
Cassette‑format lateral‑flow assays for analytes across clinical domains (e.g., thyroid, cardiac markers, cancer biomarkers, fertility/hormone markers) designed for whole blood or serum with low sample volumes and room‑temperature stability.
Biologic drug‑level cassette assays
Cassette‑format assays for detection and quantification of therapeutic biologics and biosimilars using very small sample volumes for companion diagnostic and dose‑validation workflows.
Lateral‑flow serology cassette for SARS‑CoV‑2 IgG/IgM
In‑vitro lateral‑flow immunoassay for qualitative detection of anti‑SARS‑CoV‑2 IgM and IgG from whole blood, serum or plasma; validated in clinical studies and distributed through specified professional/EUA channels.
Disposable/low‑cost portable quantitative reader
Small‑format disposable or low‑cost reader that measures lateral‑flow cassette signals and displays quantitative or qualitative results on‑device; includes LED sensor and wired/wireless output options.
Portable touchscreen quantitative reader (CMOS image sensor)
Portable reader using a CMOS image sensor and touchscreen interface for quantitative lateral‑flow analysis with multiple connectivity options (USB, Wi‑Fi, Bluetooth).
Cassette‑format lateral‑flow assays for multiple clinical analytes
Cassette‑format lateral‑flow assays for analytes across clinical domains (e.g., thyroid, cardiac markers, cancer biomarkers, fertility/hormone markers) designed for whole blood or serum with low sample volumes and room‑temperature stability.
Biologic drug‑level cassette assays
Cassette‑format assays for detection and quantification of therapeutic biologics and biosimilars using very small sample volumes for companion diagnostic and dose‑validation workflows.
Lateral‑flow serology cassette for SARS‑CoV‑2 IgG/IgM
In‑vitro lateral‑flow immunoassay for qualitative detection of anti‑SARS‑CoV‑2 IgM and IgG from whole blood, serum or plasma; validated in clinical studies and distributed through specified professional/EUA channels.
Services
Contract manufacturing (cGMP, FDA‑licensed, ISO 13485)
Manufacture of diagnostic cassettes and devices in cGMP environments with ISO 13485 quality systems and FDA medical device establishment licensing.
Assay and reagent co‑development
Collaborative co‑development from feasibility through assay and reagent design, prototype development and commercialization support.
Regulatory consulting and submission support
Consulting and support for regulatory filings and clearances including 510(k), CE marking, emergency authorizations and pre‑submission interactions with regulatory agencies.
Clinical validation and method comparison studies
Design and execution of pre‑clinical and clinical performance studies, method comparison and CLIA study support to generate performance evidence for regulatory and clinical use.
Contract manufacturing (cGMP, FDA‑licensed, ISO 13485)
Manufacture of diagnostic cassettes and devices in cGMP environments with ISO 13485 quality systems and FDA medical device establishment licensing.
Assay and reagent co‑development
Collaborative co‑development from feasibility through assay and reagent design, prototype development and commercialization support.
Regulatory consulting and submission support
Consulting and support for regulatory filings and clearances including 510(k), CE marking, emergency authorizations and pre‑submission interactions with regulatory agencies.
Clinical validation and method comparison studies
Design and execution of pre‑clinical and clinical performance studies, method comparison and CLIA study support to generate performance evidence for regulatory and clinical use.
Expertise Areas
- Point‑of‑care and self‑testing diagnostic development
- Lateral‑flow cassette assay engineering
- Portable reader hardware and connectivity
- Reagent and antibody development
Key Technologies
- Cassette‑format lateral‑flow immunoassays with internal calibration
- Quantitative lateral‑flow measurement
- Image‑based optical detection (LED/CMOS sensors)
- Portable reader connectivity (USB, Bluetooth, Wi‑Fi)