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.
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
Manufacture of diagnostic cassettes and devices in cGMP environments with ISO 13485 quality systems and FDA medical device establishment licensing.
Collaborative co‑development from feasibility through assay and reagent design, prototype development and commercialization support.
Consulting and support for regulatory filings and clearances including 510(k), CE marking, emergency authorizations and pre‑submission interactions with regulatory agencies.
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.
Manufacture of diagnostic cassettes and devices in cGMP environments with ISO 13485 quality systems and FDA medical device establishment licensing.
Collaborative co‑development from feasibility through assay and reagent design, prototype development and commercialization support.
Consulting and support for regulatory filings and clearances including 510(k), CE marking, emergency authorizations and pre‑submission interactions with regulatory agencies.
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)
News & Updates
The company has completed its pre-submission filing with the FDA for its TrueDX™ TSH system, aiming to provide quick and portable thyroid testing.
True Diagnostics received FDA clearance for its VeriClear™ Digital Early Result Pregnancy Test, capable of detecting pregnancy as early as six days before missed period.
True Diagnostics entered a collaboration with Merck KGaA to improve access to thyroid disease screening in China using TrueDX™ platform.
True Diagnostics and Veravas partnered to develop VeraTest Biotin™, a portable test to detect biotin interference in diagnostic tests.
FDA 510(k) Clearance for VeriClear™ Pregnancy Test
FDA clearance for a digital pregnancy test capable of early detection.
CE Mark for TrueDX™ PSA Test in Europe
European CE mark approval for prostate-specific antigen test.
The company has completed its pre-submission filing with the FDA for its TrueDX™ TSH system, aiming to provide quick and portable thyroid testing.
True Diagnostics received FDA clearance for its VeriClear™ Digital Early Result Pregnancy Test, capable of detecting pregnancy as early as six days before missed period.
True Diagnostics entered a collaboration with Merck KGaA to improve access to thyroid disease screening in China using TrueDX™ platform.
True Diagnostics and Veravas partnered to develop VeraTest Biotin™, a portable test to detect biotin interference in diagnostic tests.
FDA 510(k) Clearance for VeriClear™ Pregnancy Test
FDA clearance for a digital pregnancy test capable of early detection.
CE Mark for TrueDX™ PSA Test in Europe
European CE mark approval for prostate-specific antigen test.