Maine Standards Company

What Maine Standards Company does

Maine Standards Company, operating as LGC Maine Standards, is a US-based provider of calibration verification and linearity testing materials for clinical laboratories. Founded in 2001 and headquartered in Windham, Maine (with offices at 221 US Route 1, Cumberland Foreside), the company manufactures and distributes the VALIDATE product line of liquid, ready-to-use, multi-level test kits covering more than 150 analytes across clinical chemistry, immunochemistry, hemostasis, and point-of-care testing. The AccuTrak sub-brand extends into specialty diagnostics including Alzheimer's disease markers (pTau181 CSF, Abeta42), thyroid (T-Uptake), and fertility (sFlt-1). The company is a brand of LGC Clinical Diagnostics, Inc., within the global LGC Group, and operates under ISO 13485:2016 manufacturing certification.

The company's core technology asset is MSDRx Infinity, a web-based data management platform that combines account, instrument, product, and analytics tools for real-time statistical data processing, peer-group comparison, and reporting of calibration verification activities for clinical laboratories worldwide. The platform succeeded the legacy myCalVer system and is complemented by a free downloadable MSDRx Data Reduction Software for instant linearity analysis. MSDRx Infinity also hosts P.A.C.E.-approved continuing education content and provides peer-group benchmarking data that strengthens as the user base grows.

Maine Standards generates revenue through the sale of VALIDATE and AccuTrak calibration verification kits, MSDRx Infinity platform access, and a Standing Order subscription program that automates recurring shipments on customer-defined schedules with twice-yearly reminders. Go-to-market is enterprise-direct: a field sales team handles phone and email orders, supported by international distributors for markets outside the US, with content marketing, webinars, and white papers used for demand generation. The customer base spans hospital laboratories, independent diagnostic laboratories, and physician office laboratories, all of which require semi-annual calibration verification to satisfy CLIA, CAP, and ISO 15189 accreditation requirements.

Name

Maine Standards Company

Legal name

Maine Standards Company LLC

Website

https://mainestandards.com

Company type

Private

Founded year

2001

Operating status

Operating

Short description

Maine Standards Company manufactures liquid, ready-to-use VALIDATE calibration verification kits covering 150+ analytes and operates the MSDRx Infinity data management platform for clinical laboratories worldwide, serving as a brand of LGC Clinical Diagnostics within the LGC Group.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Calibration Verification Materials

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)

akta.pro secondary industries

Laboratory Quality Systems, Accreditation & Proficiency Testing Programs (HLAJAIAM), Metrology, Calibration & Testing Equipment (Balances, pH/DO, Standards) (HLAGAIAL)

Keywords

• Calibration verification materials
• Linearity testing products
• Clinical laboratory QA
• Diagnostic quality control
• Analyte verification kits

Headquarters

HQ city

Windham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. VALIDATE Calibration Verification Products: Sale of liquid, ready-to-use linearity and calibration verification test kits covering over 150 analytes across clinical chemistry, immunochemistry, hemostasis, and point of care. Products include multi-level sets and are sold directly to clinical laboratories.
2. MSDRx Infinity Platform Access: Web-based data management platform access for data processing, peer group comparison, and reporting. Data reduction services provided at no additional charge with purchase of VALIDATE products.
3. Standing Order Program: Automated recurring shipment program where calibration and AMR verification materials are shipped according to customer schedule and test menu. Provides customized, on-time shipping with twice-yearly reminders.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels8 records

Core offering

Maine Standards Company manufactures and sells liquid, ready-to-use calibration verification and linearity test kits under the VALIDATE brand, covering more than 150 analytes across clinical chemistry, immunochemistry, hemostasis, and point of care. The kits are complemented by the MSDRx Infinity web-based data management platform that provides real-time statistical processing, peer group comparison, and reporting for clinical laboratories. The company also offers the AccuTrak specialty diagnostic line, a Standing Order automated shipping program, and P.A.C.E.-approved continuing education.

Product overview

Maine Standards Company, operating as LGC Clinical Diagnostics, offers a unified portfolio of clinical laboratory quality assurance products centered on linearity and calibration verification. The core offerings include the VALIDATE brand of ready-to-use multi-level calibration verification test kits covering 150+ analytes across clinical chemistry, immunochemistry, hemostasis, and point of care; the AccuTrak product line for specific diagnostic markers; and the MSDRx INFINITY web-based data management platform (which subsumed the legacy myCalVer system) that provides real-time statistical data processing and peer group analysis. The Standing Order Program provides automated scheduling and shipping of products, while P.A.C.E. approved education resources support ongoing professional development. The MSDRx data reduction software, available at no charge, enables laboratories to perform instant linearity analysis and generate reports. These products work together to help clinical laboratories meet CLIA, CAP, and ISO 15189 accreditation requirements for calibration verification and linearity testing.

Differentiator

Problem solved

Functional benefit

Brands

• MSDRx Infinity: Comprehensive web-based data management platform for calibration verification and linearity data processing, peer group comparison and reporting.
• VALIDATE
• AccuTrak
• Multichem

Products and services

• VALIDATE Products Liquid, ready-to-use multi-level calibration verification and linearity test kits covering over 150 analytes across clinical chemistry, immunochemistry, hemostasis, and point of care. Five distinct concentration levels per kit cover the full reportable range to meet the CLSI EP06 equal-delta protocol. Sold to clinical laboratories for assay performance verification and accreditation compliance.
• MSDRx Infinity Comprehensive web-based data management platform combining account, instrument, product, and tools for real-time statistical data processing, peer group comparison, and reporting of calibration verification and linearity activities for clinical laboratories worldwide.
• AccuTrak Products
• Standing Order Program
• MSDRx Data Reduction Software

Quantifiable outcome

• Data reduction reports returned within 5 business days
• +1 more outcomes

Named customers4 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• LGC Clinical Diagnostics, Inc.coreStrategic or Co-development PartnerMaine Standards Company is a brand name for LGC Clinical Diagnostics, Inc. The company operates as part of the LGC Group, a global life sciences tools company. Maine Standards manufactures VALIDATE calibration verification products under the LGC Clinical Diagnostics umbrella.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Bio-Rad Laboratories: Bio-Rad's Quality Controls division (Liquichek, InteliQ) manufactures third-party clinical laboratory QC and calibration verification materials covering hundreds of analytes. Directly comparable to Maine Standards' VALIDATE product line in customer base, regulatory positioning and product format.
• Randox Laboratories: Randox produces the Acusera range of third-party quality controls and calibration verification sera for clinical chemistry, immunoassay and other disciplines. Targets the same clinical laboratory accreditation requirements as Maine Standards with multi-level, ready-to-use kits.
• Streck: Streck manufactures control materials and calibrators for clinical and research laboratories, including hematology and molecular diagnostics. Comparable in serving IVD quality control and calibration needs for hospital and reference laboratories.

Emerging players

• Sun Diagnostics: Sun Diagnostics produces Liquichek-style linearity and calibration verification sets for clinical chemistry, specialty diagnostics and immunoassays. A smaller, niche-focused peer with overlapping analyte coverage and customer base.

Broad incumbents

• Roche Diagnostics: Roche's cobas platform bundles proprietary PreciControl and other QC/calibration materials with its installed base of clinical chemistry and immunoassay analyzers. Represents the OEM-vertical-integration threat to Maine Standards as labs may default to vendor-supplied verification materials.
• Siemens Healthineers: Siemens offers proprietary QC and calibration verification consumables (e.g., ADVIA Centaur, Atellica) tightly integrated with its immunoassay and chemistry analyzers. Comparable in serving clinical lab accreditation needs but bundled with instrument sales rather than sold as independent third-party kits.
• Abbott Diagnostics: Abbott provides QC and calibration verification materials (e.g., Alinity, ARCHITECT) bundled with its clinical chemistry and immunoassay analyzer installed base. Represents both a competitor for calibration verification spend and a partner relationship for instrument-specific VALIDATE kit development.
• Thermo Fisher Scientific (Thermo Scientific): Through its Specialty Diagnostics and clinical controls portfolio, Thermo Fisher supplies QC materials, calibrators and verification products to clinical labs globally. Operates as a broad incumbent with overlapping products but a much wider portfolio than Maine Standards' focused offering.
• Beckman Coulter: Beckman Coulter sells proprietary QC and calibration verification materials aligned with its DxH, Access and DxC instrument families for hematology, chemistry and immunoassay. Comparable as a vendor-bundled alternative to Maine Standards' third-party kits across similar lab disciplines.

Others

• SeraCare (LGC Clinical Diagnostics): SeraCare is a sister brand of Maine Standards within LGC Clinical Diagnostics, providing reference materials, plasma/serum controls and molecular QC for IVD and clinical trials. Comparable in regulatory positioning and customer base but focused on molecular and reference materials rather than chemistry linearity.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/LGCStandards
• YouTubeyoutube.com/user/lgcgroupvideo
• Facebookfacebook.com/LGCgroup/?ref=page_internal
• LinkedInlinkedin.com/company/lgc-maine-standards

Revenue estimate

Valuation estimate

Number of profiles

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 Maine Standards Company