Sekisui Diagnostics

Name

Sekisui Diagnostics

Legal name

Sekisui Diagnostics, LLC

Website

https://sekisuidiagnostics.com

Company type

Private

Founded year

1980

Operating status

Operating

Headcount range

501–1,000 employees

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers (423450)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Laboratory Automation, Sample Prep & Liquid Handling (IVD Lab Diagnostics) (HLAHAAAN)

Keywords

• Clinical chemistry reagents
• Point-of-care diagnostics
• Molecular diagnostic tests
• Diagnostic enzymes
• Pre-analytic systems

Headquarters

HQ city

Lexington

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Clinical Chemistry Reagents Sales: Sale of clinical chemistry reagents including SEKURE® reagents, calibrators, controls, and linearity materials. Products are used to perform over 1.8 billion clinical chemistry tests each year on various branded clinical chemistry analyzers. Revenue generated through direct sales and distributor networks.
2. Point-of-Care Testing Products: Sale of rapid diagnostic tests (OSOM® brand) and molecular testing products (Metrix® platform) for point-of-care settings including physician offices, clinics, and hospitals. Products detect various conditions including respiratory infections, women's health issues, and infectious diseases.
3. Enzyme Manufacturing: Manufacturing and sale of high-quality enzymes and specialty biochemicals to global healthcare market. Enzymes are used in pharmaceutical production, clinical chemistry reagents, and POC/biosensor devices. Products include clinical chemistry enzymes, pharmaceutical antibiotic production enzymes, biosensors, molecular enzymes, and immunodiagnostics enzymes.
4. Pre-Analytic Systems: Supply of raw materials for blood collection tube manufacturers including serum separation gel and blood clotting accelerant. These materials ensure reliable diagnostic results in plastic vacuum blood collection tubes.
5. Contract Development and Manufacturing Services (CDMO): End-to-end manufacturing services for liquid and lyophilized products from design to full-scale commercialization. Services include formulation, design, development, filling, QC testing, packaging & labeling. Located in Prince Edward Island, Canada with global logistics capabilities.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

Sekisui Diagnostics develops, manufactures, and supplies in vitro diagnostic (IVD) products including clinical chemistry reagents, rapid point-of-care tests (OSOM), molecular diagnostic platforms (Metrix), diagnostic and pharmaceutical enzymes, and pre-analytic raw materials (serum separation gel, blood clotting accelerant) for blood collection tubes. The company also offers end-to-end contract development and manufacturing (CDMO) services for liquid and lyophilized products to global healthcare customers.

Product overview

Sekisui Diagnostics offers a diversified portfolio of diagnostic products organized into five main categories: Clinical Chemistry (reagents, calibrators, controls, and the STAT-Site WB meter for glucose/ketone testing), Point-of-Care Testing (OSOM rapid tests for respiratory, women's health, and infectious disease applications, plus the Metrix molecular platform for COVID/Flu testing), Enzymes (clinical chemistry enzymes, pharmaceutical antibiotic production enzymes, biosensor enzymes, molecular enzymes for PCR, and immunodiagnostics), Pre-Analytic Systems (blood collection tube raw materials including serum separation gel and clotting accelerants), and Contract Manufacturing Services (CDMO for liquid/lyophilized products). The company operates manufacturing facilities in Canada, UK, and US, serving healthcare professionals, distributors, and manufacturers globally.

Differentiator

Problem solved

Functional benefit

Brands

• OSOM®: Brand for rapid diagnostic tests including COVID-19, Flu, RSV, Strep A, Trichomonas, BVBLUE, Mono, H. pylori, and hCG tests.
• SEKURE®
• Metrix®
• STAT-Site®
• QC Inside®
• DC-Lineate
• Smartbond Streptavidin

Products and services

• Clinical Chemistry Reagents Broad line of 65+ reagents including cardiovascular, diabetes, renal, liver, therapeutic drug, and specialty assays used on automated clinical chemistry analyzers by hospital and reference laboratories.
• SEKURE Clinical Chemistry Reagents Ready-to-use liquid stable open-channel clinical chemistry reagents designed to help laboratories meet operational and financial goals with exceptional performance and field-proven reliability.
• Calibrators, Controls & Linearity Materials Range of calibrators, controls, and linearity materials for commonly performed clinical chemistry tests to improve laboratory analytical performance, including DC-Lineate tri-level calibration material.
• STAT-Site WB Meter CLIA waived point-of-care meter for beta-ketone and glucose measurements from whole blood with results in less than 10 seconds, intended for clinical point-of-care settings.
• Bulk Reagents Clinical chemistry reagents manufactured in bulk for instrument manufacturers (OEM), including assays for Acetaminophen, Albumin, ALP, ALT, Ammonia, Amylase, AST, Calcium, Cholesterol, CO2, Creatine Kinase, Creatinine, CRP, and others.
• Clinical Chemistry Enzymes Diagnostic enzymes for clinical chemistry applications including cholesterol oxidase, glucose dehydrogenase, CNPG3, and valinomycin for diabetes, lipid metabolism, renal function, and cardiovascular testing.
• Pharmaceutical Antibiotic Production Enzymes Enzymes for efficient inactivation of beta-lactam antibiotics including penicillins, cephalosporins, and carbapenems for environmental and quality control testing in antibiotic manufacturing.
• Biosensor Enzymes Enzymes for biosensor applications focused on determination of D-glucose in clinical analysis and self-monitoring blood glucose meters, including glucose oxidase and glucose dehydrogenase.
• Molecular Enzymes Enzymes for PCR applications including KOD DNA polymerases, reverse transcriptase, Taq DNA polymerase, and realtime PCR master mix for infectious disease and oncology testing.
• Immunodiagnostics Enzymes and Reagents Detection and labeling materials for immunoassay applications including streptavidin, SAV magnetic beads, alkaline phosphatase, horseradish peroxidase, and Smartbond Streptavidin for chemiluminescent signal detection.
• OSOM Rapid Tests Broad range of rapid point-of-care lateral flow diagnostic tests including COVID-19, RSV, Flu SARS-CoV-2 Combo, BVBLUE, H. pylori, iFOB, Mono, Strep A, Trichomonas, Ultra hCG Combo, and Ultra Plus Flu A&B tests for physician offices and clinics.
• Metrix COVID/Flu Test Highly accurate molecular multiplex test that detects and differentiates between SARS-CoV-2, Flu A, and Flu B at the point-of-care with results in 20 minutes and minimal hands-on time; no calibration or maintenance required.
• Metrix COVID-19 Test Molecular test for qualitative detection of SARS-CoV-2 nucleic acids accommodating both nasal or saliva samples, delivering lab-quality results in 30 minutes or less on the Metrix platform.
• Serum Separation Gel Raw material for plastic vacuum blood collection tubes allowing stable and reliable separation of blood clot and serum with high resistance to irradiation, sold to blood collection tube manufacturers.
• Blood Clotting Accelerant Raw material for blood collection tubes ensuring reliable diagnostic results through accelerated blood clot formation, supplied to blood collection tube manufacturers.
• Contract Development and Manufacturing Services (CDMO) End-to-end contract manufacturing services for liquid and lyophilized products from design to full-scale commercialization, including formulation, filling, QC testing, packaging, and labeling, operated from the Prince Edward Island, Canada facility with ISO 8 cleanrooms and lyophilization capacity.

Quantifiable outcome

• Over 1.8 billion clinical chemistry tests performed annually using SEKISUI products
• +2 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Microbix Biosystems Inc.coreStrategic or Co-development Partner · 12 November 2025Microbix Biosystems Inc. partnered with SEKISUI Diagnostics to support U.S. commercialization of COVID/Flu molecular test. Microbix supplies REDxFLOQ QAPs (Quality Assessment Products) that help ensure test accuracy and compliance. The test, authorized under FDA Emergency Use Authorization, detects SARS-CoV-2, Influenza A, and Influenza B within 20 minutes using the Metrix® platform.
• Aptitude Medical SystemscoreStrategic or Co-development PartnerSEKISUI Diagnostics partnered with Aptitude to provide Metrix COVID-19 tests to the point-of-care and home test markets. This partnership expands distribution of the Metrix molecular testing platform.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• QuidelOrtho: QuidelOrtho (formerly Quidel + Ortho Clinical Diagnostics) develops immunoassays, clinical chemistry reagents, and rapid point-of-care diagnostics — directly comparable to Sekisui's clinical chemistry reagent plus OSOM rapid-test portfolio.
• Bio-Rad Laboratories: Bio-Rad manufactures clinical chemistry controls, calibrators, quality-control materials and diagnostic reagents — a direct peer to Sekisui's SEKURE reagents and calibrators/controls/linearity line.
• OraSure Technologies: OraSure develops rapid point-of-care diagnostics (infectious disease, women's health) and is a comparable peer to Sekisui's OSOM rapid-test franchise and home-test positioning.
• Trinity Biotech: Trinity Biotech manufactures clinical chemistry and diagnostic tests for point-of-care and laboratory use — comparable in scale, scope, and customer base to Sekisui's clinical chemistry and POC business.
• EKF Diagnostics: EKF Diagnostics produces point-of-care analyzers, clinical chemistry reagents, and OEM enzymes/biochemicals — closely comparable to Sekisui across POC, clinical chemistry, and enzyme product lines.
• Meridian Bioscience: Meridian develops and manufactures diagnostic test kits and reagents for infectious disease, gastrointestinal, and respiratory testing — comparable to Sekisui's OSOM and Metrix franchises.
• Response Biomedical: Response Biomedical develops rapid point-of-care immunoassay tests (cardiovascular, infectious disease) — a similar mid-cap POC diagnostic peer in scope and distribution.

Broad incumbents

• Hologic: Hologic is a larger, diversified diagnostics company with molecular and rapid-test capabilities — overlapping Sekisui's molecular Metrix platform but operating at significantly broader scale.
• Beckman Coulter (Danaher): Beckman Coulter is a major clinical chemistry and immunoassay analyzer/reagent incumbent that competes with Sekisui's SEKURE open-channel reagents on the same analyzer platforms.
• Roche Diagnostics: Roche Diagnostics is the global IVD leader across clinical chemistry, immunoassays, and molecular — the dominant incumbent against which Sekisui's specialty POC and enzyme businesses compete for share.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sekisui-diagnostics-llc

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries3 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 Sekisui Diagnostics