Helena Laboratories

What Helena Laboratories does

Helena Laboratories Corporation is a privately held American manufacturer of clinical laboratory instruments and diagnostic reagents, founded in 1966 by Tipton and Ann Golias in Taylor, Michigan and relocated to Beaumont, Texas in 1970, where it operates 250,000+ square feet of integrated research, manufacturing, and administrative facilities. The company designs, produces, and sells electrophoresis systems (gel and capillary), densitometers, hemostasis analyzers, point-of-care platelet function testing systems, and an extensive line of proprietary consumables including immunofixation antisera, hemoglobin and lipoprotein kits, coagulation reagents, and fecal occult blood tests, serving major medical centers, reference laboratories, hospitals, physician office laboratories, and point-of-care facilities.

The product portfolio is anchored by three electrophoresis platforms: the Touch Series (SPIFE Touch, ESH Touch, QuickScan Touch Plus) for automated gel electrophoresis; the V8 Nexus CE and V8 UltraCE capillary electrophoresis systems, including the Nexus Max autoloader for up to 440 samples; and the SPIFE Nexus walkaway gel system. Supporting instruments is a deep consumables catalog tying reagent SKUs (SPIFE Touch kits for proteins, lipoproteins, hemoglobins, immunofixation, cholesterol profiles including direct Lp(a), CK/LD isoenzymes, alkaline phosphatase, and A1AT) to each installed analyzer. The hemostasis line includes Plateletworks, Actalyke/MAX-ACT, Cascade Abrazo, AggRAM, and ELISA-based assays.

The business operates a hybrid go-to-market: ~75 US field specialists provide direct enterprise sales and technical service supported by a 24-hour hotline and EDI ordering, while three wholly-owned international subsidiaries (Australia, Europe/UK, Japan) and 65+ international distributors cover more than 60 countries. Pricing is quote-based (F.O.B. Beaumont, net 10 days) with monthly rental and leasing options introduced. Recurring revenue is generated through proprietary consumables and service agreements (CSA, EWSA, CRA), with ISO 13485:2016 and MDSAP certifications supporting regulatory clearance across the US, Canada, and Europe.

Name

Helena Laboratories

Legal name

Helena Laboratories Corporation

Website

https://helena.com

Company type

Private

Founded year

1966

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Helena Laboratories is a privately held, founder-owned US manufacturer founded in 1966 that designs and sells clinical electrophoresis instruments, hemostasis analyzers, point-of-care platelet testing systems, and proprietary consumables, serving medical centers, reference laboratories, hospitals, and physician offices across 60+ countries.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

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

akta.pro secondary industries

Hematology & Coagulation Diagnostics (HLAHAAAB), Laboratory Automation, Sample Prep & Liquid Handling (IVD Lab Diagnostics) (HLAHAAAN), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• Clinical electrophoresis instruments
• Hemostasis diagnostics systems
• Point-of-care coagulation testing
• Laboratory densitometry analyzers
• Clinical chemistry reagent kits

Headquarters

HQ city

Beaumont

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Clinical Laboratory Instruments and Diagnostics Sales: Sale of electrophoresis analyzers, densitometers, hemostasis reagents and instruments, immunology and protein diagnostic systems, disposable laboratory plasticware, test kits for fecal occult blood, and other laboratory solutions.
2. Consumables and Reagents: Recurring revenue from proprietary reagents, gels, buffers, controls, and consumables required for operation of Helena instruments.
3. Service and Support Contracts: Extended warranty and service agreements including Consolidated Service Agreement (CSA), Extended Warranty Service Agreement (EWSA), and Comprehensive Replacement Agreement (CRA) for instrument maintenance.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

Helena Laboratories manufactures and sells clinical laboratory instruments and reagents for electrophoresis-based diagnostics and hemostasis testing. Its portfolio includes automated gel and capillary electrophoresis analyzers, densitometers, point-of-care platelet function and coagulation systems, ELISA assays, fecal occult blood test kits, and a broad menu of consumable reagent kits for protein, lipoprotein, hemoglobin, immunofixation, isoenzyme, and cholesterol profiling used by clinical laboratories worldwide.

Product overview

Helena Laboratories is an American manufacturer of clinical laboratory instruments and reagents founded in 1966, offering a comprehensive portfolio centered on electrophoresis technology and hemostasis diagnostics. The product ecosystem is organized around three main electrophoresis platforms: the automated Touch Series (SPIFE Touch, ESH Touch, QuickScan Touch Plus) for gel electrophoresis with integrated workflow; the V8 Nexus CE and V8 UltraCE capillary electrophoresis systems for high-throughput serum protein and immunofixation testing; and the Titan III/IV cellulose acetate systems for traditional electrophoresis. Supporting these instruments is an extensive line of consumables including specialized assay kits for proteins, lipoproteins, hemoglobins, cholesterol profiles (including direct Lp(a) measurement), isoenzymes (CK and LD), alkaline phosphatase, A1AT, and immunofixation. The hemostasis portfolio includes point-of-care systems (Plateletworks, Actalyke/MAX-ACT, Cascade Abrazo), platelet aggregation testing (AggRAM), and a comprehensive range of coagulation reagents and ELISA assays. Additional products include fecal occult blood tests (ColoScreen), ProtoFluor Z hemoglobin analysis, and disposable laboratory plasticware. All products are supported by a global distribution network with three international subsidiaries and over 65 international distributors.

Differentiator

Problem solved

Functional benefit

Brands

• ColoScreen: Fecal occult blood test kits brand trusted since 1981
• Plateletworks
• QuickScan Touch
• SPIFE Touch
• V8 Nexus
• Actalyke

Products and services

• SPIFE Nexus Gel Electrophoresis System Fully automated walkaway gel electrophoresis system with auto sampling, antisera application, and scanning, capable of processing up to 100 SPE or 15 IFE samples ready for review in about 90 minutes; integrated with V8 Nexus CE for combined gel and capillary electrophoresis workflow for clinical laboratories.
• V8 Nexus CE Capillary Electrophoresis System High-throughput automated capillary electrophoresis analyzer with auto capillary conditioning, auto maintenance, and up to six on-board reagents; used by clinical laboratories for serum protein electrophoresis and immunofixation testing.
• Nexus Max Autoloader Stockyard autoloader accessory for the V8 Nexus that enables fully automated autoloading of up to 440 samples for high-volume capillary electrophoresis testing with no user involvement.
• V8 UltraCE Capillary Electrophoresis System Capillary electrophoresis system for serum protein and immunofixation electrophoresis testing in clinical laboratories.
• SPIFE Touch Gel Electrophoresis Analyzer Advanced gel electrophoresis analyzer 30% faster than previous models, featuring touch screen interface, automated sample application, reagent application, and staining; supports protein, IFE, hemoglobin, cholesterol, isoenzyme, lipoprotein, A1AT, and oligoclonal banding assays for clinical labs.
• ESH Touch Automated Sample Handler Automated sample handler that transfers samples directly from primary patient tubes to barcoded sample trays ready for the SPIFE Touch; features 100-sample capacity with programmable dilutions and positive patient ID for high-volume labs.
• QuickScan Touch Plus Densitometer Flat-bed densitometer for imaging and quantitation of agarose gels and cellulose acetate, with advanced data management, full LIS interface, optional Myeloma Module for tracking patient results over time, and network capability for remote editing and review.
• Titan III and IV Cellulose Acetate Electrophoresis Systems Cellulose acetate electrophoresis systems for clinical diagnostics including hemoglobin, lipoprotein, and protein separations, foundational to Helena's clinical electrophoresis product line.
• Plateletworks Point-of-Care Testing System Point-of-care platelet function testing system providing functional platelet count plus platelet aggregation or inhibition percent activity using standard ADP, arachidonic acid, and collagen agonists; for rapid assessment at the point of care.
• Actalyke and MAX-ACT Hemostasis Analyzers Hemostasis analyzers for Activated Clotting Time (ACT) testing with a full line of ACT tubes (glass bead, kaolin, celite, and MAX-ACT variants) for monitoring heparin dosing in clinical settings.
• Cascade Abrazo POC Coagulation System Point-of-care hemostasis testing system for coagulation testing including PT, aPTT, and activated clotting time assays used in clinical settings.
• AggRAM Platelet Aggregation System Platelet aggregation testing system for comprehensive hemostasis assessment in clinical laboratories.
• ColoScreen Fecal Occult Blood Test Kits Fecal occult blood test kits for colorectal cancer screening, including ColoScreen ES, trusted in physician offices and clinical laboratories since 1981.
• ProtoFluor Z Hemoglobin Analysis System Hemoglobin analysis system for electrophoresis testing in clinical laboratories.
• ELISA Assay Kits Enzyme-linked immunosorbent assay kits for hemostasis testing including vWF:Ag, Protein C, and Protein S assays used by clinical laboratories.
• QuickGels Pre-Cast Electrophoresis Gels Pre-cast electrophoresis gels designed for small-volume laboratories to perform various tests including proteins, lipoproteins, hemoglobins, isoenzymes, and immunofixation.
• TITAN GEL High-Resolution Electrophoresis Gels High-resolution electrophoresis gels for protein separations and immunofixation testing in clinical laboratories.
• Disposable Laboratory Plasticware Disposable laboratory plasticware for clinical diagnostics testing, including sample cups, trays, and other consumable supplies.
• Helena Service and Support Agreements Extended warranty and service agreements including Consolidated Service Agreement (CSA), Extended Warranty Service Agreement (EWSA), and Comprehensive Replacement Agreement (CRA) for Helena instrument maintenance and support.

Quantifiable outcome

• Up to 100 SPE or 15 IFE samples ready for review in about 90 minutes
• +2 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core.

• Helena Laboratories (Australia) Pty. LtdcoreChannel Partner/ Reseller/ DistributorInternational subsidiary serving Australia, New Zealand, and surrounding Oceania markets. Located in Mount Waverley, Victoria, Australia. Provides local sales, service, and support for Helena products.
• Helena BioSciences EuropecoreChannel Partner/ Reseller/ DistributorInternational subsidiary serving European markets. Headquarters located in Gateshead, Tyne and Wear, UK at Queensway South, Team Valley Trading Estate. Covers all European Union and non-EU European countries.
• Kabushiki Kaisha Helena KenkyujyocoreChannel Partner/ Reseller/ DistributorInternational subsidiary serving Japan market. Located at 9-21-19 Tokiwa, Urawa-ku, Saitama-shi, Japan. Provides local sales, service, and support for Helena diagnostic products.
• Intermedico (Canada)coreChannel Partner/ Reseller/ DistributorExclusive distributor for Electrophoresis, Hemostasis, and POC products in Canada. Located at 50 Valleywood Drive, Markham, Ontario L3R 6E9, Canada.
• N.L. Diagnostica (Brazil)coreChannel Partner/ Reseller/ DistributorDistributor for Electrophoresis, Hemostasis, and POC products in Brazil. Located at Rua Vigario Albernaz No. 371, Sao Paulo-SP, Brazil.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Diagnostica Stago: Specialist hemostasis and coagulation diagnostics manufacturer with STA line of analyzers and reagents. Directly comparable to Helena's hemostasis franchise (AggRAM, Cascade Abrazo, coagulation reagents) in serving hospital and reference coagulation labs.
• Sebia: Global leader in clinical capillary and gel electrophoresis for protein, immunofixation, hemoglobin, and HbA1c testing. Sebia is Helena's most direct competitor in protein electrophoresis, serving the same clinical laboratory customer base with overlapping assays and capillary/gel instrument formats.
• The Binding Site (part of Thermo Fisher Scientific): Specialist in specialty protein diagnostics and multiple myeloma monitoring assays (e.g., Freelite, Hevylite). Highly comparable to Helena's protein electrophoresis and myeloma tracking franchise, with shared customer base in hematology-oncology and clinical chemistry labs.

Broad incumbents

• Beckman Coulter (Danaher): Diversified IVD manufacturer with AU/DxH chemistry and hematology analyzers. Overlaps with Helena in clinical chemistry labs and competes in hemostasis testing through Access/DxH platforms, though not a direct electrophoresis specialist.
• Werfen (IL/Hemosil): Specialty diagnostics provider with significant hemostasis franchise (ACL TOP, HemosIL reagents). Comparable to Helena's hemostasis product line, including coagulation reagents, factor-deficient substrates, and platelet aggregation reagents.
• Roche Diagnostics: Largest global IVD player with cobas chemistry/immunoassay platforms covering serum proteins, HbA1c, and cardiovascular markers. Indirectly competes with Helena by absorbing protein and hemoglobin testing onto high-throughput immunoassay analyzers in large reference labs.
• Siemens Healthineers (Diagnostics): Major diversified IVD manufacturer whose ADVIA Centaur and Atellica platforms offer protein and HbA1c immunoassays that compete with Helena's electrophoresis menu. Overlaps with Helena in clinical chemistry labs but competes primarily through automated immunoassay rather than electrophoresis.
• Abbott Diagnostics: Global IVD leader with ARCHITECT and Alinity platforms covering clinical chemistry, immunoassay, and HbA1c. Competes with Helena for protein and hemoglobin testing volume on automated immunoassay analyzers across large hospital systems.

Others

• Helena BioSciences Europe (internal subsidiary): Wholly-owned European subsidiary of Helena Laboratories. Included to reflect that international expansion is delivered through Helena's own regional entities rather than third-party competitors; comparable as a channel rather than competitor.
• Helena Laboratories (Australia) Pty. Ltd: Wholly-owned Australian/Oceania subsidiary. Included for completeness of Helena's own distribution footprint; not a competitor but relevant for understanding regional revenue concentration.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/c/HelenaLabsUSA
• Facebookfacebook.com/HelenaLaboratories
• LinkedInlinkedin.com/company/helena-laboratories-corporation
• Xx.com/helenalabs

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Helena Laboratories