Epitope Diagnostics

What Epitope Diagnostics does

Epitope Diagnostics, Inc. is a privately held, ISO 13485:2016 certified and US FDA registered/licensed medical device manufacturer founded in 2003 and headquartered at 17034 Camino San Bernardo in San Diego, California. The company develops and commercializes in-vitro diagnostic immunoassays across three proprietary methodology platforms — Chemiluminescence Immunoassay (CLIA) with ECL100 and ECL25 automated analyzers, Automated ELISA, and the US-patented EPITUUB® lateral flow rapid test — alongside specialty antibodies, sample collection devices, and automation equipment. Its product catalog spans more than 200 kits across ten clinical areas including cardiovascular disease, oncology, endocrinology, infectious disease, gastrointestinal disease, autoimmune disease, anemia, and calcium/bone metabolism, with niche specialty offerings such as GFAP for neurological disorders, anti-auristatin antibodies for antibody-drug conjugate development, and the patented sQED stool collection device.

The business operates a B2B model selling catalog-priced kits, instruments, and reagents to professional clinical laboratories and academic/pharmaceutical research institutions worldwide, with separate product catalogs maintained for US and international markets. Go-to-market combines direct enterprise sales via its website, industry trade show presence at MEDICA, ADLM, Medlab Middle East, ESCMID Global, and CALCLP, and channel partnerships — most notably Immundiagnostik, Inc. for North American distribution of the ECL100 analyzer and 50+ CLIA kits since October 2025. The company previously participated in the MetroConnect 2018 export assistance program and has expanded its menu with COVID-19 serology kits (2020), automated CLIA analyzers (2023), and a planned advanced CLIA portfolio for 2026 covering therapeutic drug monitoring and additional specialty areas.

Revenue mechanics are unit-based with quote-on-request pricing across a diversified SKU mix; the company does not publicly disclose revenue and operates without disclosed external institutional investment or parent company affiliation. Management is led by Ping Gao as President and CEO, with Stefanie Dallozette as Business Operations Manager, and the firm holds US patents on both the EPITUUB® rapid test platform and the sQED stool collection device, with CE marks on key products for the European market.

Name

Epitope Diagnostics

Legal name

Epitope Diagnostics, Inc.

Website

https://epitopediagnostics.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

Epitope Diagnostics is a San Diego-based ISO 13485 certified and US FDA registered medical device manufacturer developing CLIA, ELISA, and rapid test immunoassay kits, automated analyzers, and specialty antibodies for clinical diagnostics laboratories and research institutions worldwide.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics (IVD)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Clinical Chemistry & Immunoassay Systems (HLAHAAAA)

akta.pro secondary industries

Immunoassay Diagnostics (ELISA, chemiluminescence, serology) (HLAAALAB), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• In-vitro diagnostics manufacturing
• Chemiluminescence immunoassay kits
• ELISA diagnostic kits
• Lateral flow rapid tests
• Specialty antibodies research

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Operations, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. Diagnostic Test Kits Sales: Sale of chemiluminescence immunoassay (CLIA) kits, ELISA kits, and lateral flow rapid test kits for various clinical applications including cardiovascular disease, oncology, endocrinology, infectious disease, gastrointestinal disease, autoimmune disease, and anemia. Products available for both IVD (in-vitro diagnostic) use and research use only (RUO).
2. Specialty Antibodies: Sale of monoclonal and polyclonal antibodies for research and diagnostic applications, including anti-auristatin antibodies for ADC development and various biomarker-specific antibodies
3. Automation Equipment: Sale of automated analyzers including QSE180 stool autosampler for laboratory automation
4. Sample Collection Kits: Sale of specialized collection devices including fecal sample collection tubes and extraction kits

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

Epitope Diagnostics is a medical device manufacturer that develops and produces chemiluminescence immunoassay (CLIA) kits, ELISA kits, lateral flow rapid test kits, automated immunoassay analyzers (ECL100, ECL25, QSE180), specialty antibodies, and patented sample collection devices for clinical diagnostics and research laboratories globally. The product portfolio spans cardiovascular, oncology, endocrinology, infectious disease, gastrointestinal, autoimmune, anemia, and bone metabolism diagnostic testing under its proprietary EPITUUB® and sQED patented platforms.

Product overview

Epitope Diagnostics is an ISO 13485:2016 certified and US FDA registered medical device manufacturer specializing in in-vitro diagnostics for the global clinical diagnostics and research communities. The company operates three main methodology platforms: CLIA (Chemiluminescence Immunoassay), ELISA (Automated ELISA), and Rapid Test (EPITUUB US Patented). The core product portfolio includes automated analyzers (ECL100, ECL25, QSE180 autosampler), over 200+ diagnostic kits across 10 disease categories (Autoimmune, Cardiovascular, Endocrinology/Diabetes, Gastrointestinal, Infectious Disease, Anemia, Calcium/Bone Metabolism, Tumor Markers/Cancer Research), specialized antibodies for research use, and sample collection devices. Notable products include COVID-19 ELISA kits, Anti-Müllerian Hormone kits, Vitamin D assays, and antibody-drug conjugate detection kits. The company partners with Immundiagnostik for North American distribution of CLIA products and holds multiple US patents including the EPITUUB rapid test technology and sQED stool collection device.

Differentiator

Problem solved

Functional benefit

Brands

• EPITUUB®: US Patented rapid test brand including immunochemical fecal occult blood rapid test kits for professional laboratory use.

Products and services

• QSE180 Stool Sample Autosampler and Auto-Extractor Fully automated, random-access stool sample autosampler and auto-extractor with throughput of 180 tests/hour and 32 onboard reagent positions, designed for automated fecal testing workflows including Calprotectin, Pancreatic Elastase-1, and Occult Blood tests in clinical laboratories.
• ECL100 Chemiluminescent Immunoassay Analyzer Fully automated random-access chemiluminescence immunoassay analyzer with throughput of 100 tests per hour and onboard reagent capacity for running CLIA kits across the company's diagnostic test menu.
• ECL25 Chemiluminescent Immunoassay Analyzer Fully automated chemiluminescent immunoassay analyzer designed for clinical and research use, compatible with GFAP CLIA Kit and other routine and niche panel kits.
• sQED Stool Sample Quantitative Collection and Extraction Device US-patented stool sample collection and extraction device that standardizes collection without traditional weighing, enabling direct use for automated immunoassay systems such as the QSE180.
• EPITUUB Rapid Test Platform US-patented lateral flow rapid test platform for point-of-care and professional laboratory diagnostics, marketed under the EPITUUB® brand.
• GFAP CLIA Kit Quantitative CLIA kit for measurement of human Glial Fibrillary Acidic Protein (GFAP) in serum, compatible with ECL100 and ECL25 analyzers, for neurological disorders including traumatic brain injury, stroke, Alzheimer's disease, glioblastoma, and Parkinson's disease.
• COVID-19 ELISA Kit Series (KT-1032, KT-1033, KT-1034, KT-1035, KT-1036) Series of ELISA kits (KT-1032 through KT-1036) for qualitative and quantitative detection of SARS-CoV-2 IgG and IgM antibodies targeting nucleocapsid and spike proteins, including neutralizing antibody detection; available for IVD use (CE marked) and research use only (US).
• Human Anti-Müllerian Hormone (AMH) ELISA Kit ELISA kit for quantitative determination of human AMH in serum and lithium heparin plasma to assess ovarian reserve and predict IVF response; available as KTR-804 (research use) and KT-804 (IVD use).
• Total 25-OH Vitamin D ELISA Kit Robust 2-hour assay measuring both 25-hydroxy Vitamin D2 and D3 forms in serum or EDTA-plasma with analytical sensitivity of 0.96 ng/ml; CE marked for IVD use.
• Human ACTH ELISA Kit 2-hour ACTH assay with high analytical sensitivity (LLOD: 0.4 pg/mL) and robust assay performance for detecting elevated and deficient ACTH levels in EDTA-plasma associated with Addison's disease, Cushing's syndrome, and other conditions.
• Anti-Auristatin Monoclonal Antibodies and ELISA Kits (MAB30699, MAB30700, KTR-782, KTR-783) Monoclonal antibodies (MAB30699 for MMAE, MAB30700 for MMAF) and matching ELISA kits (KTR-782 for MMAE-ADC, KTR-783 for MMAF-ADC) for detecting antibody-drug conjugates used in cancer therapy and ADC pharmacokinetics.
• FOB Rapid Test Kit (KT-111) Immunochromatographic lateral flow assay for qualitative determination of human hemoglobin in feces, used for colorectal cancer screening and GI bleeding detection; compatible with the EPC-100 reader.
• Immunochemical Fecal Occult Blood Rapid Test Kit (KT-313) EPITUUB rapid test kit for qualitative detection of fecal occult blood with 99% sensitivity and 100% specificity, 5-15 minute read time, for colorectal cancer screening.
• EPC-100 Rapid Test Cassette Reader Automated cassette reader instrument compatible with the FOB Rapid Test Kit (KT-111) for standardized interpretation of EPITUUB rapid test results.
• Autoimmune Disease CLIA and ELISA Kit Suite Comprehensive kit suite for autoimmune disease diagnostics including Anti-thyroid peroxidase antibody (SKT-027R), Anti-Thyroglobulin Antibody (SKT-044R), Anti-FcεRIα Autoantibody (KTR-802), Anti-IgE Autoantibody (KTR-803), Anti-Gliadin IgA/IgG (KTR-830/831), Anti-Tg IgG (KTR-832), Anti-TPO IgG (KTR-833), and Anti-CaSR IgG (KTR-840).
• Endocrinology & Diabetes CLIA and ELISA Kit Suite Extensive endocrinology portfolio including CLIA and ELISA kits for AMH (CL0804R), FSH (SKT-016R), LH (SKT-017R), Prolactin (SKT-018R), Estradiol (SKT-019R), Testosterone (SKT-020R), hCG (SKT-021R), Progesterone (SKT-022R), TSH (SKT-015R), Free T4 (SKT-037R), Free T3 (SKT-038R), Total T4 (SKT-039R), Total T3 (SKT-040R), Thyroglobulin (SKT-060R), Growth Hormone (SKT-042R), C-peptide (SKT-023R), Insulin (SKT-048R), and FGF-21 kits (KTR-873/874/879).
• Gastrointestinal Disease CLIA and ELISA Kit Suite Comprehensive GI disease panel including Fecal Calprotectin CLIA/ELISA (CL0849R, KTR-849), Pancreatic Elastase-1 (CL0006R), H. pylori Antigen (CL0826R, KTR-824/826), Giardia Antigen (CL0813R, KTR-838), Cryptosporidium Antigen (CL0814R, KTR-839), C. difficile GDH/Toxin (CL0824R, CL0827R, CL0828R, KTR-828/834/835/836), Fecal Occult Blood (CL0850R, KTR-850, KT-313, KT-111), Gastrin-17 (SKT-045R), Pepsinogen I/II (CL0810R/CL0811R, KTR-810/811), Anti-tTG IgG/IgA (CL0004R/CL0005R), Anti-DGP IgA/IgG (CL0007R/CL0008R), Infliximab/Anti-Infliximab (CL0009R/CL0010R), and sample collection kits.
• Cardiovascular Disease CLIA and ELISA Kit Suite Cardiovascular marker kits including High-sensitivity Cardiac Troponin T (SKT-050R), Myoglobin (SKT-051R), Creatine kinase-MB (SKT-024R), D-Dimer (SKT-052R), NT-proBNP (SKT-031R), Fetuin-A ELISA (KTR-800/KTR-900), NGAL ELISA (KTR-883), Calprotectin (KTR-885), and Myeloperoxidase ELISA (KTR-890).
• Specialty Antibodies for Research Use Research-use antibodies including Anti-MMAE monoclonal (MAB30699) and polyclonal (30699), Anti-MMAF monoclonal (MAB30700) and polyclonal (30700), Anti-DM1 (30698), Anti-FGF-21 N-terminal/C-terminal (30618/30661), Anti-Chromogranin A antibodies (30704-30715), Anti-NGAL (30657/30658), with various conjugations available for biomarker research and ADC development.

Quantifiable outcome

• 99% test sensitivity and 100% test specificity achieved by FOB Rapid Test
• +2 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature5 records

Partnerships

One partnership is on record.

• Immundiagnostik, Inc.coreChannel Partner/ Reseller/ Distributor · 22 October 2025Immundiagnostik partnered with Epitope Diagnostics to offer the ECL100 chemiluminescent analyzer and over 50 CLIA kits across North America. Collaboration aims to improve laboratory efficiency, address staffing challenges, and enhance clinical outcomes by providing high-quality diagnostic solutions.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Bio-Rad Laboratories: US-based life science and clinical diagnostics manufacturer offering ELISA kits, immunoassay controls, and clinical chemistry systems that overlap substantially with Epitope's specialty IVD and research-use-only immunoassay portfolio.
• Roche Diagnostics: Global IVD leader offering the cobas Elecsys chemiluminescent immunoassay platform across the same disease categories as Epitope (cardiovascular, infectious disease, oncology, endocrinology), providing both competitive context and a benchmark for the broader CLIA market scale.
• Siemens Healthineers: Operates the ADVIA Centaur and Atellica IM chemiluminescent immunoassay systems covering endocrinology, oncology, infectious disease, and specialty biomarkers—a broad-overlap competitor to Epitope in routine and specialty clinical lab diagnostics.
• DiaSorin S.p.A. Italian IVD multinational with the LIAISON chemiluminescent immunoassay platform spanning infectious disease, endocrinology, and specialty biomarkers—a directly comparable CLIA franchise to Epitope's ECL100/ECL25, but with global installed-base scale an order of magnitude larger.
• Tosoh Bioscience: Japanese life-sciences company with the AIA automated CLIA immunoassay analyzer family and broad specialty diagnostic menu—including endocrinology and infectious disease—that competes directly with Epitope's ECL analyzers and CLIA kits in clinical labs.
• QuidelOrtho Corporation: Specialty diagnostics company with VITROS chemiluminescent and ELISA platforms spanning infectious disease, immunoassay, and reproductive testing—comparable to Epitope's clinical diagnostic kit portfolio at greater commercial scale.
• Abbott Diagnostics: Operates the ARCHITECT/Alinity ci-series chemiluminescent immunoassay systems covering routine and specialty testing, representing one of the largest installed bases Epitope's ECL analyzers compete against in clinical reference laboratories.

Emerging players

• Boditech Med: Korean IVD company with the AFIAS and ichroma automated immunoassay analyzers and rapid test platforms, comparable in product architecture and geographic ambition to Epitope's CLIA + EPITUUB rapid test dual-platform strategy.
• Snibe Diagnostic: Chinese IVD company whose MAGLUMI chemiluminescent immunoassay system competes head-to-head in routine and specialty CLIA menus, particularly across Asia-Pacific and emerging markets where Epitope also sells. Comparable automated CLIA analyzer-plus-kit commercial model.

Direct peers

• Immundiagnostik AG: German specialty immunoassay manufacturer and developer of the same biomarker menu Epitope targets. Immundiagnostik is both Epitope's North America distribution partner and a direct competitor in CLIA/ELISA kits across fecal, cardiovascular, and bone metabolism diagnostics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Epitope Diagnostics