True Diagnostics
True Diagnostics is a Carlsbad, California-based developer and manufacturer of rapid in-vitro immunodiagnostic test systems built on its patented TrueDX multi-point calibration platform, serving point-of-care providers, OTC self-testers, OEM partners, and government biodefense programs.
- Company typePrivate
- Founded2010
- HeadquartersCarlsbad, United States
- Headcount1–10
- GTM typeB2B and B2C
- OfferingHardware or Manufacturing
What True Diagnostics does
True Diagnostics, Inc. is a privately held research, development, and manufacturing company founded in 2010 and headquartered in Carlsbad, California, specializing in rapid in-vitro immunodiagnostic test systems. The company builds its products around the proprietary TrueDX platform, anchored by a patented multi-point integrated calibration method that converts conventional qualitative lateral flow assays into quantitative tests with 18-month room-temperature shelf stability. The product portfolio includes the TrueDX Cassette, the TrueDXP Disposable Reader (a hand-held digital reader with OLED display and optional Bluetooth), the higher-spec TrueDX Reader (CMOS sensor, resistive touch screen, QC check, optional Wi-Fi), and supporting modules TrueDXQDF (quantum dot fluorescence for ~100x photo-bleaching stability vs. organic dyes) and TrueDXM (multiplexed picoliter-volume liquid handling). Assay menu spans thyroid, cardiac, cancer, fertility, and biologics monitoring panels.
True Diagnostics firmographics
Firmographics- Name
- True Diagnostics
- Legal name
- True Diagnostics, Inc.
- Website
- https://truediag.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- True Diagnostics is a Carlsbad, California-based developer and manufacturer of rapid in-vitro immunodiagnostic test systems built on its patented TrueDX multi-point calibration platform, serving point-of-care providers, OTC self-testers, OEM partners, and government biodefense programs.
- Ownership category
- akta.pro rank
True Diagnostics industry classification
Industry- Product category
- In-Vitro Immunodiagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Companion Diagnostics (CDx) & Precision Medicine IVD (HLAHAAAJ)
- akta.pro secondary industries
- Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL), Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO), Companion Diagnostics (CDx) Development & Commercialization (HLAAANAC)
Keywords
Where True Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Carlsbad
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
True Diagnostics business model
Business model- GTM type
- B2B and B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Operations, Personnel, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Test Systems and Reagents: Research, development and manufacturing company specializing in rapid in-vitro immunodiagnostic test systems and reagents. Revenue generated from sale of proprietary diagnostic cassettes, disposable readers, and assay reagents.
- Over-the-Counter Products: Disposable readers and test products sold through retail pharmacy chains for consumer self-testing.
- Partnership Development Services: Provides design, development, and manufacturing services for assay development to commercial partners. Partners with companies to develop tests with tough specifications including high sensitivity, quantification, multiplexing, and extended shelf life stability.
Go-to-market motion3 records
Distribution channels3 records
Marketing channels1 record
True Diagnostics product offering
Product offeringCore offering
True Diagnostics is a research, development, and manufacturing company that develops and produces proprietary rapid in-vitro immunodiagnostic test systems and reagents. Its core offering centers on the TrueDX platform—patented lateral-flow cassettes with integrated calibration paired with hand-held digital readers—and a menu of quantitative assay panels (thyroid, cardiac, cancer markers, fertility, biologics) sold to clinical providers, OTC retail consumers, and commercial assay-development partners.
Product overview
True Diagnostics is a research, development, and manufacturing company specializing in rapid in-vitro immunodiagnostic test systems. The core product portfolio is built around the proprietary TrueDX technology platform, which includes the TrueDX Cassette (lateral flow test with patented internal calibration), paired with the TrueDXP Disposable Reader (hand-held digital reader with OLED display and optional Bluetooth) and the TrueDX Reader (higher-specification platform with CMOS sensor and touch screen). Supporting modules include TrueDXQDF (quantum dot fluorescence enhancement for improved sensitivity) and TrueDXM (multiplexing capability). The company offers a range of TrueDX Assays spanning thyroid (TSH, Free-T4), cardiac (NT-proBNP, CKMB, Troponin I, Myoglobin), cancer (PSA, AFP, CEA), fertility (HCG), and biologics monitoring (Rituximab, Natalizumab, Trastuzumab) profiles. All assays are stable at room temperature for up to 18 months.
Differentiator
Problem solved
Functional benefit
Brands
- TruDia: Brand name used in logo and product references
- TrueDX
- TrueDXP
- TrueDXQDF
- TrueDXM
- TrueDXP Disposable Reader
- TrueDX Reader
- TrueDX Assays
Products and services
- TrueDX Cassette
- TrueDXP Disposable Reader
- TrueDX Reader
- TrueDX Assays
- TrueDXQDF Quantum Dot Fluorescence System
- TrueDXM Multiplexed Assay System
Quantifiable outcome
- All TrueDX Assays stable at room temperature for up to 18 months
- +2 more outcomes
Companies that use True Diagnostics
Customer profileNamed customers3 records
Segments5 records
Ideal customer profiles4 records
True Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
True Diagnostics partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and minor.
- BARDA (Biomedical Advanced Research and Development Authority)coreBARDA awarded True Diagnostics a project valued at approximately $11 million to develop a rapid diagnostic test capable of detecting Ebola and Marburg viruses. The project focuses on accelerating biothreat response and supporting future outbreak preparedness. This represents a significant government partnership for advanced diagnostic development.
- Abreos BiosciencescoreBrad Messmer, CEO of Abreos Biosciences, is quoted endorsing the TrueDX technology platform, stating it bridges the gap between the ease and speed of traditional qualitative lateral flow assays and the quantitative rigor needed for clinical assays. Abreos appears to be an early adopter and strategic user of the technology.
- Global PartnersminorCompany states that global partners entrust them with concepts, design, development, manufacturing and support processes to grow their iconic brands. These are unspecified commercial partnerships for assay development and manufacturing services.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
True Diagnostics competitors and assessment
Company assessmentBroad incumbents
- QuidelOrtho: QuidelOrtho is a major diagnostics company with a broad rapid immunoassay and point-of-care testing portfolio (e.g., Sofia, Triage), directly overlapping with TrueDX's POC and OTC diagnostic positioning and serving similar physician office, urgent care, and retail channels.
- Abbott (Diagnostics): Abbott operates the largest point-of-care diagnostics franchise globally, including the i-STAT system, Binax Now, and extensive OTC rapid tests — a dominant incumbent against whom TrueDX's POC and OTC reader must compete for hospital and retail shelf space.
- Becton, Dickinson and Company (BD): BD's Diagnostic Systems segment includes the Veritor point-of-care immunoassay platform and a large biodefense/CDC product portfolio, making it both a competitor in POC diagnostics and a potential federal contracting counterpart to TrueDX on BARDA-style awards.
Direct peers
- Chembio Diagnostics: Chembio develops rapid point-of-care immunodiagnostic tests, including lateral flow assays for infectious disease and biothreat detection — closely comparable to TrueDX's cassette-plus-reader model and BARDA-aligned focus on emerging pathogen preparedness.
- OraSure Technologies: OraSure is best known for OTC consumer diagnostics (e.g., OraQuick HIV, HCV) sold through retail pharmacy, and also serves biodefense and public health markets — directly parallel to TrueDX's OTC self-test and biothreat segments.
- Response Biomedical: Response Biomedical develops rapid quantitative immunoassays (RAMP platform) used in point-of-care clinical and biodefense settings — a near-direct comparability to TrueDX's cassette-plus-reader quantitative approach, including cardiovascular and infectious disease markers.
- Mesa Laboratories: Mesa Labs' Diagnostics segment (including AccuClean and related rapid lateral flow readers) competes in benchtop and field rapid diagnostic readers, broadly comparable to TrueDX's TrueDXP Disposable Reader and TrueDX Reader product family.
- Akers Biosciences: Akers Biosciences has historically developed rapid, disposable, single-use point-of-care diagnostic test readers and cartridges — very similar in product architecture and OTC/POC commercial positioning to TrueDX's disposable reader strategy.
Emerging players
- LumiraDx: LumiraDx built a connected point-of-care immunoassay/molecular platform with a small benchtop reader and microfluidic test strips — overlapping with TrueDX's POC strategy but with a higher-priced, connected design targeting global health and primary care.
- GenMark Diagnostics (acquired by Roche): GenMark's ePlex system pioneered a sample-to-answer cartridge-plus-reader model for syndromic and infectious disease diagnostics, a useful analog for how a small TrueDX-like platform can be scaled or acquired once menu and clinical evidence mature.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks6 records
Key highlights8 records
Customer concentration
True Diagnostics social profiles
Digital presenceTrue Diagnostics compliance and trust
Trust signalCompliance2 records
True Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
True Diagnostics leadership team
Management profileNumber of profiles
Profiles1 record
True Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
True Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about True Diagnostics
What does True Diagnostics do?
True Diagnostics is a research, development, and manufacturing company that develops and produces proprietary rapid in-vitro immunodiagnostic test systems and reagents. Its core offering centers on the TrueDX platform—patented lateral-flow cassettes with integrated calibration paired with hand-held digital readers—and a menu of quantitative assay panels (thyroid, cardiac, cancer markers, fertility, biologics) sold to clinical providers, OTC retail consumers, and commercial assay-development partners.
Is True Diagnostics a public or private company?
True Diagnostics is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was True Diagnostics founded?
True Diagnostics was founded in 2010. It employs 1 to 10 people.
Where is True Diagnostics based?
True Diagnostics is headquartered in Carlsbad, United States, in the North America region.
How does True Diagnostics make money?
Three revenue lines are on record. Diagnostic Test Systems and Reagents are the primary driver. The others are over-the-Counter Products and partnership Development Services.
Who are True Diagnostics's main competitors?
Broad incumbents on record are QuidelOrtho, Abbott (Diagnostics) and Becton, Dickinson and Company (BD). Direct peers are Chembio Diagnostics, OraSure Technologies, Response Biomedical, Mesa Laboratories and Akers Biosciences. Emerging players are LumiraDx and GenMark Diagnostics (acquired by Roche).
Does True Diagnostics have an API?
No public API is recorded for True Diagnostics.
What industry is True Diagnostics in?
True Diagnostics's product category is In-Vitro Immunodiagnostics. Its primary akta.pro industry code is HLAHAAAJ, Companion Diagnostics (CDx) & Precision Medicine IVD, with a secondary code of HLAAAMAL, Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls). Its NAICS code is 325413 and its SIC code is 2835.