Sun Diagnostics

What Sun Diagnostics does

Sun Diagnostics, LLC is a privately held, FDA-registered in vitro diagnostic (IVD) company founded in 2012 by John Contois, PhD and headquartered in New Gloucester, Maine. The company develops and manufactures quality control materials and interference testing products used by IVD manufacturers, clinical laboratories, and researchers to validate assays, verify manufacturer interference claims, and comply with CLSI and ISO standards. Its flagship offering is the ASSURANCE™ line of interference test kits (INT-01 through INT-09), which provide human-sourced, concentrated interferent materials — including triglyceride-rich lipoproteins, hemolysate, protein, bilirubin, HAMA-positive serum, rheumatoid factor-positive plasma, drug panels, and endogenous metabolites — at up to 20x CLSI-recommended concentrations for spiking into serum or urine pools per CLSI EP7 guidelines.

The company complements its catalog products with specialized reagents including LipoSep IP™ (an immunoprecipitation reagent for HDL isolation), Dextran Sulfate sodium salt, murine monoclonal antibodies to apo(a) and apo B, and research-use-only assays such as the Lp(a)-P ELISA (which measures lipoprotein(a) particle number via apo B detection to bypass the isoform size bias of conventional Lp(a) mass assays) and a Rapid Biotin microtiter plate assay. A custom QC materials service manufactures unassayed, human-serum-based quality controls to customer specifications for analyte levels and batch sizes. Upcoming products include a Serum Indices (LIH) QC for hemolysis/icterus/lipemia verification and an insulated specimen courier lockbox insert.

Sun Diagnostics sells direct from its Maine headquarters in the United States and uses two exclusive regional distributors — Bio-Connect Diagnostics B.V. (Netherlands) for Europe and Shigematsu & Co., Ltd. for Japan. Revenue is generated primarily through one-time, pay-as-you-go purchases of catalog kits ($455–$1,895) and individual reagents ($97.50–$545 per vial), supplemented by custom QC development agreements. The company maintains a scientific content marketing presence through its website, blog, conference posters (AACC, National Lipid Association), and downloadable Excel-based analysis tools aligned with CLSI EP7, EP17, and EP37 guidance. No external venture or growth capital has been disclosed; cumulative known funding consists of three small Maine Technology Institute grants totaling approximately $74,000 between 2014 and 2017.

Name

Sun Diagnostics

Legal name

Sun Diagnostics, LLC

Website

https://sundiagnostics.us

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

Sun Diagnostics is a privately held, FDA-registered Maine-based company that develops human-sourced in vitro diagnostic quality control materials and ASSURANCE™ interference test kits for IVD manufacturers, clinical laboratories, and researchers conducting assay validation.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostic Quality Control Products

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

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Release Testing & Batch Certification (QC) (HLAGADAC)

Keywords

• In vitro diagnostics
• Interference test kits
• Quality control materials
• Clinical laboratory reagents
• Assay validation products

Headquarters

HQ city

New Gloucester

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations

Revenue model

1. IVD Interference Test Kit Sales: Sun Diagnostics generates revenue primarily through the direct sale of its ASSURANCE™ interference test kit product line. Products are sold as complete kits (INT-01, INT-04, INT-06) or as individual interferent vials. Revenue is one-time purchase based, with repeat purchases driven by customer testing needs and new product releases.
2. Custom QC Material Development & Sales: Sun Diagnostics creates customized, unassayed QC materials to customer specifications for manufacturers, laboratories, and researchers. Revenue generated through bespoke development agreements and subsequent material supply. Customers can request small, medium, or large batch sizes, packaged at Sun Diagnostics' facility or shipped in bulk.
3. Specialized Reagent Sales (LipoSep IP, Dextran Sulfate, Antibodies): Sale of specialized laboratory reagents including LipoSep IP™ immunoprecipitation reagent, Dextran Sulfate sodium salt, and monoclonal antibodies (Anti-apo(a), Anti-apo B). Products are sold in standard sizes with per-unit pricing (e.g., LipoSep IP at $440 per 125 tests; Dextran Sulfate at $97.50 per 5-gram bottle).

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Sun Diagnostics develops, manufactures, and sells in vitro diagnostic (IVD) quality control products, primarily its ASSURANCE™ Interference Test Kits that contain human-sourced concentrated interferent materials (hemolysate, lipemia, icterus, proteins, HAMA, RF, drugs, and endogenous metabolites) for clinical laboratory assay validation. The company also produces the Lp(a)-P ELISA for lipoprotein particle measurement, LipoSep IP immunoprecipitation reagent for HDL isolation, the Rapid Biotin Assay, dextran sulfate and monoclonal antibodies, and offers custom QC material manufacturing services tailored to customer specifications.

Product overview

Sun Diagnostics provides a comprehensive portfolio of In Vitro Diagnostic products focused on assay validation and quality assurance. The flagship ASSURANCE™ Interference Test Kit product line includes six kit types (INT-01 through INT-09) for testing interference from routine interferents, HAMA, rheumatoid factor, drugs, and endogenous metabolites. Supporting products include the LIPOSEP IP™ immunoprecipitation reagent for HDL isolation, Lp(a)-P ELISA for lipoprotein particle measurement, Rapid Biotin Assay, Dextran Sulfate, and custom quality control materials. The company operates as an FDA-registered facility offering both catalog products and custom manufacturing services for IVD manufacturers, clinical laboratories, and researchers.

Differentiator

Problem solved

Functional benefit

Brands

• Assurance™: Interference Test Kits product line including INT-01 (Routine Interferents), INT-02 (HAMA), INT-03 (RF), INT-04 (Drug Interferents), INT-06 (Endogenous Interferents), and INT-09 (Biotin) for laboratories and manufacturers to evaluate assay interference.

Products and services

• ASSURANCE INT-01 Routine Interferents Test Kit Comprehensive interference testing kit containing triglyceride-rich lipoproteins (>15,000 mg/dL), human hemolysate (>10,000 mg/dL), protein mixture (>20 g/dL), conjugated bilirubin (>400 mg/dL), and unconjugated bilirubin (>400 mg/dL) for evaluating common interferents in clinical assays. Priced at $1,375 per kit.
• ASSURANCE INT-02 HAMA Interference Test Kit Test kit containing HAMA-positive human serum for assessing human anti-mouse antibody interference in immunoassays that use murine monoclonal antibodies. Available in 1 mL vials at $545/vial.
• ASSURANCE INT-03 RF Interference Test Kit Test kit containing RF-positive human plasma for evaluating rheumatoid factor interference in clinical immunoassays. Typical concentrations 1,000–9,700 IU/mL depending on testing method. Priced at $455/vial.
• ASSURANCE INT-04 Drug Interference Test Kit Comprehensive drug interference testing kit containing 15 drug interferents (acetaminophen, N-acetylcysteine, acetylsalicylic acid, ampicillin sodium, cefoxitin sodium, cyclosporine, doxycycline HCl, heparin, ibuprofen, levodopa, methyldopa, metronidazole, phenylbutazone, rifampicin, and theophylline) at 20x recommended test concentrations. Priced at $1,895 per kit.
• ASSURANCE INT-06 Endogenous Interferents Test Kit Test kit containing seven endogenous interferents: creatinine (300 mg/dL), glucose (20,000 mg/dL), glycerol (340 mg/dL), lactate (1,800 mg/dL), pyruvate (100 mg/dL), urea/BUN (2,400 mg/dL), and uric acid (470 mg/dL). Priced at $815 per kit.
• SunDx Lp(a)-P ELISA (Lipoprotein(a) Particle Number) Research-use-only ELISA for quantitative measurement of Lipoprotein(a) particle number in nmol/L. Uses apo B detection to overcome apo(a) size isoform bias that affects conventional Lp(a) mass assays. Linear range: 13–400 nmol/L; correlation to reference method r=0.971.
• SunDx Rapid Biotin Assay (INT-09) Research-use-only microtiter plate assay for measuring potentially interfering biotin concentrations in patient samples. 75-minute assay with LoB of 13 ng/mL, LoD of 32 ng/mL, and linear range up to 200 ng/mL.
• LipoSep IP Immunoprecipitation Reagent Highly specific immunoprecipitation reagent using monospecific antibodies directed toward lipoproteins for isolation of HDL particles in human serum. Available in 25 mL units (125 tests) at $440 per unit.
• Custom QC Materials Customized, unassayed quality control materials manufactured to customer specifications. Human serum-based matrix similar to patient samples, available in liquid ready-to-use format at customized analyte levels and batch sizes (small, medium, or large) for IVD manufacturers, clinical laboratories, and researchers.
• Sun Diagnostics Serum Indices (LIH) QC Upcoming quality control material for hemolysis, icterus, and lipemia detection verification. Liquid ready-to-use format with room-temperature stability designed to support compliance with CLSI C56-A and ISO 15189:2022.

Quantifiable outcome

• Sun Diagnostics' Lp(a)-P ELISA correlates strongly with the reference method (r=0.971), with no statistically significant association between bias and kringle 4 type 2 repeats
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered minor and core.

• California InnovationsminorStrategic or Co-development Partner · 1 January 2022Sun Diagnostics collaborated with California Innovations to develop a prototype insulated courier lockbox insert. The insert uses high-density expanded polyethylene (EPE) foam with radiant barrier film laminate to protect clinical specimens from temperature extremes during courier transport. Sun Diagnostics developed the product concept and tested the insert; California Innovations provided the manufacturing capability. A poster was presented at the 2022 AACC Annual Meeting documenting the product's performance.
• Bio-Connect Diagnostics B.V.coreChannel Partner/ Reseller/ Distributor · 1 September 2014Bio-Connect Diagnostics B.V. serves as Sun Diagnostics' exclusive European distribution partner, handling all European sales and customer support. Located in Huissen, The Netherlands, the partner manages distribution across the Netherlands, Belgium, Luxembourg, and broader European markets. Contact: Tel +31 26 326 4460, Fax +31 26 326 4461, Email [email protected]. The partnership was announced in September 2014.
• Shigematsu & Co., Ltd.coreChannel Partner/ Reseller/ DistributorShigematsu & Co., Ltd. is Sun Diagnostics' exclusive distribution partner for Japan. The partnership enables Japanese customers to access Sun Diagnostics' ASSURANCE interference test kits, Lp(a)-P ELISA, LipoSep IP, and other products. Contact: Phone +81-(0)6-6231-6146, Email [email protected].

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Bio-Rad Laboratories: Industry-leading IVD quality control franchise (Unity Real Time, Liquichek, InteliQ) and the dominant third-party QC provider. Direct overlap with Sun Diagnostics' human-serum-based QC and interference testing product lines, but at vastly greater scale and with instrument-platform integrations.
• LGC Group: Large reference-materials and measurement-science company (formerly LGC Standards/Maine Standards) producing clinical QC materials, calibrators, and proficiency testing. Overlaps with Sun Diagnostics' Custom QC business and serum-based QC portfolio serving IVD manufacturers and clinical labs.
• Roche Diagnostics: Largest IVD manufacturer and offers proprietary QC, calibration verification, and interference testing solutions tied to its cobas/Roche instrument platforms. Competes with Sun Diagnostics for IVD manufacturer QC budgets and biotin-interference testing demand via the Elecsys platform.
• Thermo Fisher Scientific (Clinical Diagnostics QC): Diversified life-sciences giant with a clinical diagnostics QC, calibrator, and reagent business serving clinical labs and IVD manufacturers. Competes with Sun Diagnostics' catalog and custom QC offerings through its wider portfolio and global reach.

Direct peers

• Randox Laboratories: Direct competitor in third-party clinical QC materials and EQA programs (Acusera, RIQAS). Both companies sell human-serum-based QC and serve IVD manufacturers and clinical labs with multi-analyte controls — making Randox the closest head-to-head peer in the catalog QC business.
• Streck, Inc. Independent manufacturer of hematology and clinical chemistry QC materials, including stabile cellular controls and inter-laboratory QC programs. Comparable niche-specialist positioning focused on lab-quality and preanalytical reliability, with a similar focus on human-sourced materials.

Emerging players

• Maine Molecular Quality Controls: Independent molecular and serology QC manufacturer based in Maine, focused on third-party QC for infectious disease and molecular assays. Most comparable in size and founder-led operational model to Sun Diagnostics, and a direct competitor for IVD manufacturer and reference-lab QC contracts.
• SERO (SERO AS): Specialty manufacturer of liquid, human-serum-based clinical chemistry QC materials with a comparable niche focus on commutable, third-party controls. Overlaps directly with Sun Diagnostics' Custom QC Materials business on the manufacturer and reference-lab side.
• ZeptoMetrix: Specialty manufacturer of QC materials, proficiency testing, and disease-state samples for infectious disease and molecular diagnostics. Adjacent to Sun Diagnostics' IVD-manufacturer QC business with a similar specialty / niche-specialist model.

Others

• Quotient Sciences: Adjacent CDMO/laboratory services company supporting diagnostic and therapeutic development with custom reagent, QC, and analytical services. Relevant as a custom-manufacturing peer for IVD manufacturers, although broader in scope than Sun Diagnostics' QC-only focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/Sun-Diagnostics-109125964785717
• LinkedInlinkedin.com/company/sun-diagnostics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds3 records

Investors1 record

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 Sun Diagnostics