Diazyme Laboratories

What Diazyme Laboratories does

Diazyme Laboratories, Inc. is a privately held specialty diagnostics company founded in 2000 and headquartered in Poway, California, that develops, manufactures, and distributes in vitro diagnostic reagents built on proprietary enzyme and immunoassay technologies. Its core platforms include latex-enhanced immunoturbidimetric assays, enzyme cycling methods, and chemiluminescence-based kits, with a product catalog spanning more than 110 assays across cardiovascular (Lp(a) Molarity, PLAC, Apo B, Homocysteine), cancer (Kappa/Lambda Free Light Chain for multiple myeloma and MGUS), sepsis (Procalcitonin), diabetes (Direct HbA1c, Glycated Serum Protein), renal/pancreatic (Cystatin C, Creatinine, Lipase), liver (Total Bile Acids, ADA), gastrointestinal (Calprotectin, Lactoferrin), inflammatory (hsCRP, SAA), coagulation (D-Dimer), electrolyte (CO2), and therapeutic drug monitoring (Colorimetric Lithium) categories. The company also sells the DZ-Lite c270, a compact benchtop clinical chemistry analyzer capable of 270 tests/hour, as a captive platform for its reagent menu, with assays validated on third-party analyzers including Roche Cobas c701 and Beckman Coulter AU680.

Diazyme operates cGMP and ISO 13485–certified manufacturing and holds multiple FDA 510(k) clearances, with several recent approvals in 2025–2026 (Colorimetric Lithium, MGUS FLC, Lp(a) Molarity). It is building a research-use neurology pipeline (pTau-217/181, NfL, Aβ40/42, ApoE4) on its chemiluminescence platform. Revenue is generated primarily through recurring sales of diagnostic reagent kits (MSRPs typically $87–$1,014) and instruments, distributed via direct sales, the diazyme.com e-commerce storefront, and — following the June 2026 acquisition of Carolina Liquid Chemistries Corp. (founded 1994, Greensboro, NC) — an established value-added reseller network reaching clinical laboratories of all sizes.

Customer end-markets include clinical reference laboratories, hospital laboratories, physician office laboratories, and specialty oncology practices, supported by KOL-led content marketing, ADLM conference presence, webinars, and customer testimonials. The company remains founder-led under Managing Director Dr. Chong Yuan, with no disclosed funding rounds or institutional investors in the available data.

Name

Diazyme Laboratories

Legal name

Diazyme Laboratories, Inc.

Website

https://diazyme.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

101–250 employees

Short description

Diazyme Laboratories is a private specialty IVD manufacturer using proprietary enzyme and immunoassay technologies to produce 110+ clinical chemistry assays for reference labs, hospitals, and physician office labs, anchored by its DZ-Lite c270 benchtop analyzer and FDA 510(k)-cleared reagents.

Ownership category

akta.pro rank

Product category

Clinical Chemistry Diagnostic Reagents

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

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Toxicology & Therapeutic Drug Monitoring Laboratories (HLAFAMAF)

Keywords

• Clinical chemistry reagents
• Diagnostic immunoassays
• Latex-enhanced turbidimetric assays
• FDA 510(k) cleared diagnostics
• Benchtop chemistry analyzers

Headquarters

HQ city

Poway

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Reagent Sales: Diazyme generates revenue primarily through the sale of diagnostic reagent kits for clinical chemistry analyzers. Products include biomarker assays (cardiovascular, cancer, metabolic markers), calibrators, and controls sold in kit formats with various catalog numbers. Customers purchase reagents on a recurring basis as they consume testing supplies.
2. Instrument Sales: Sale of the DZ-Lite c270 clinical chemistry analyzer and related instruments. The company sells automated chemistry analyzers that run their proprietary reagent menu.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Diazyme Laboratories develops, manufactures, and distributes FDA 510(k)-cleared diagnostic reagent kits built on proprietary latex-enhanced immunoturbidimetric and enzyme cycling chemistries for use on automated clinical chemistry analyzers and chemiluminescence instruments. Its portfolio spans cardiovascular, cancer, sepsis, metabolic, renal, liver, gastrointestinal, inflammatory, coagulation, and vitamin biomarker assays, supported by the DZ-Lite c270 benchtop clinical chemistry analyzer. Customers are clinical reference laboratories, hospital labs, and physician office laboratories in the U.S. and global export markets.

Product overview

Diazyme Laboratories is a diagnostic reagent manufacturer offering a comprehensive portfolio of clinical chemistry assays and the DZ-Lite c270 benchtop analyzer. The company specializes in proprietary enzyme and immunoassay technologies including latex-enhanced immunoturbidimetric, enzymatic, and chemiluminescence methods. The product portfolio spans multiple biomarker categories: cancer markers (free light chain kappa/lambda assays for multiple myeloma), cardiovascular markers (Lp(a) Molarity Assay, PLAC Test, Apo B, Homocysteine), sepsis markers (Procalcitonin), diabetes markers (Direct HbA1c, Glycated Serum Protein), renal/pancreatic markers (Cystatin C, Creatinine, Lipase), liver markers (Total Bile Acids, ADA), gastrointestinal markers (Calprotectin, Lactoferrin), inflammatory markers (hsCRP, SAA), coagulation markers (D-Dimer), electrolyte markers (CO2), and vitamin markers (Vitamin D). The company also offers a pipeline of neurology CLIA kits for research use including pTau-217, pTau-181, NfL, Aβ40, Aβ42, and ApoE4. Products are designed for use on automated clinical chemistry analyzers with the DZ-Lite c270 as a compact dedicated platform.

Differentiator

Problem solved

Functional benefit

Brands

• DZ-Lite c270: Fully-automated clinical chemistry analyzer capable of performing up to 270 tests/hour
• DZ-Lite

Products and services

• DZ-Lite c270 Clinical Chemistry Analyzer Fully-automated benchtop clinical chemistry analyzer that performs up to 270 tests per hour, supports 1-, 2-, 3-, and 4-reagent assays, and runs over 110 specialty, general chemistry, and drug of abuse Diazyme assays (more than 80 CLIA-categorized tests); designed for reference labs, hospitals, and physician offices.
• Lipoprotein(a) Molarity Assay FDA 510(k)-cleared assay for quantitative determination of lipoprotein(a) levels in human serum and plasma reported in molar units (nmol/L). Provides isoform-independent measurement that addresses apo(a) isoform heterogeneity for consistent cardiovascular risk assessment across patient populations and laboratories.
• Colorimetric Lithium Assay FDA 510(k)-cleared single-reagent colorimetric assay for quantitative in vitro determination of lithium in human serum or EDTA plasma, based on lithium-porphyrin complex formation under alkaline pH with an innovative pH stabilizer for improved on-board reagent stability; MSRP $174.00 - $430.00.
• Procalcitonin (PCT) Assay FDA 510(k)-cleared homogeneous immunoturbidimetric assay for quantitative determination of procalcitonin in serum, EDTA, or lithium heparin plasma for sepsis diagnosis; rising PCT concentrations can be detected within 2-6 hours after infectious challenges.
• Calprotectin Assay Particle-enhanced immunoturbidimetric assay for quantitative determination of calprotectin in stool samples; calprotectin in the sample binds to specific anti-calprotectin antibodies coated on latex particles.
• Human Lambda Free Light Chain Assay Immunoturbidimetric assay for quantitative determination of Lambda Free Light Chain concentration in serum (standard AMI 3.5-200 mg/L; extended mode 3.5-4000 mg/L); used in conjunction with Kappa FLC for diagnosis and monitoring of multiple myeloma and MGUS.
• Human Kappa Free Light Chain Assay Immunoturbidimetric assay for quantitative determination of Kappa Free Light Chain concentration in serum (standard AMI 3.5-200 mg/L; extended mode 3.5-4000 mg/L); used in conjunction with Lambda FLC for diagnosis and monitoring of multiple myeloma and MGUS.
• Lactoferrin Assay Particle-enhanced immunoturbidimetric assay for quantitative determination of fecal lactoferrin; lactoferrin in the sample binds to specific anti-lactoferrin antibodies coated on latex particles.
• Cystatin C Assay Dual liquid stable latex-enhanced immunoturbidimetric method for early detection of kidney disease; cost-effective alternative for renal function assessment; MSRP $174.00 - $944.00.
• Glycated Serum Protein Assay Enzymatic assay for glycated serum protein providing improved specificity and reliability compared to conventional NBT-based methods, with total CV ≤ 1.3%; MSRP $87.00 - $1,014.00.
• Creatinine Assay Liquid stable enzymatic creatinine assay offering advantages over conventional Jaffe method; uses non-caustic formulation without picric acid that can stain analyzer tubing; MSRP $87.00 - $373.00.
• Total Bile Acids Assay (Enzyme Cycling Method) Liquid-stable ready-to-use total bile acids assay using enzyme cycling for liver function assessment; suitable for both manual and automated chemistry analyzers; MSRP $102.00 - $539.00.
• EZ Vitamin D Assay First and only 2-reagent latex-enhanced immunoturbidimetric assay for 25-OH Vitamin D runnable on general clinical chemistry analyzers.
• PLAC Test for Lp-PLA2 Activity FDA-cleared blood test used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease.
• Lipase Assay Dual vial liquid stable lipase assay using methyl-resorufin with extended linear range up to 250 U/L and minimal interferences from triglyceride (300 mg/dL), hemoglobin (150 mg/dL), and bilirubin (up to 20 mg/dL); FDA 510(k) cleared and CE marked.
• Carbon Dioxide Enzymatic (CO2) Assay Single-vial liquid-stable reagent system with neutral pH minimizing CO2 absorption from air; uses enzyme cycling method at 405 nm with linear range 1.12-50 mmol/L; FDA 510(k) cleared and CE marked.
• Direct HbA1c (On-Board Lysis) Assay Patented single-channel enzymatic HbA1c assay with on-board lysis eliminating offline pretreatment steps and the need for a dedicated total hemoglobin channel; wide analytical measurement range 4.0%-12.0% HbA1c; FDA 510(k) cleared, CE marked, and Health Canada Registered.
• Apolipoprotein B (Apo B) Assay Immunoturbidimetric Apo B assay with linear range 3.6-240 mg/dL; used as an aid for assessing risk of coronary artery disease; FDA 510(k) cleared, CE marked, and Health Canada Registered.
• Adenosine Deaminase (ADA) Assay Kinetic enzymatic assay for determination of adenosine deaminase activity in serum and plasma with linear range 0-200 U/L, intra-assay %CV < 4.5% and inter-assay %CV < 5.0%; for tuberculosis and other ADA-related testing, CE marked (Research Use Only in USA).
• Homocysteine Enzymatic Assay Liquid-stable enzymatic homocysteine assay with linear range 3-50 µmol/L, intra/inter %CV < 5.9%, not interfered by endogenous cystathionine for use in renal disease patients; alternative to immunochemical methods; CE marked; MSRP $174.00 - $1,011.00.
• D-Dimer Assay Highly sensitive latex-enhanced immunoturbidimetric D-Dimer assay with linearity of 0.15-8.0 µg/mL FEU; used as an aid in detecting intravascular coagulation and fibrinolysis; MSRP $156.00 - $472.00.
• hsCRP (High Sensitivity C-Reactive Protein) Assay Latex-enhanced turbidimetric immunoassay for high-sensitivity C-reactive protein with linear range 0.20-20 mg/L extending below conventional CRP assays for evaluation of inflammation in otherwise healthy individuals; MSRP $156.00 - $340.00.

Quantifiable outcome

• Improved turnaround time from 3-5 days to same-day results with in-house free light chain testing
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 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.

• Carolina Liquid Chemistries Corp. (CLC)coreStrategic or Co-development Partner · 1 June 2026Diazyme acquired the business of Carolina Liquid Chemistries Corporation in June 2026. CLC is an FDA registered manufacturer and value-added reseller of chemistry systems and reagents, founded in 1994 and headquartered in Greensboro, North Carolina. The acquisition positions Diazyme to enhance diagnostic capabilities and deliver more comprehensive solutions to reference and clinical laboratories. Prior to acquisition, CLC was a partnership partner expanding the test menu on Diazyme's DZ-Lite c270 analyzer since January 2023.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• The Binding Site (Thermo Fisher Scientific): The Binding Site, now part of Thermo Fisher, is a long-established specialist in free light chain (kappa/lambda) and specialty protein diagnostics for multiple myeloma and other gammopathies — directly competing with Diazyme's flagship FLC assays. Highly comparable in product category, target customer (hospital/clinical labs), and clinical use case.
• Sekisui Diagnostics: Sekisui Diagnostics develops and manufactures a broad portfolio of clinical chemistry and specialty immunoassay reagents run on automated chemistry analyzers, including cardiac, sepsis, and inflammatory markers that overlap directly with Diazyme's menu. Closely comparable in business model, customer base (clinical/reference labs), and reagent-on-third-party-analyzer approach.
• EKF Diagnostics: EKF Diagnostics manufactures specialty IVD reagents and point-of-care analyzers for clinical chemistry and specialty markers, with a similar 'specialty-on-benchtop-analyzer' positioning to Diazyme. Comparable as a specialty IVD reagent maker serving clinical laboratories of various sizes.
• ALPCO Diagnostics: ALPCO Diagnostics is a smaller specialty immunoassay manufacturer focused on clinical and research assays including metabolic, inflammation, and gut-health markers — overlapping with Diazyme's calprotectin, lactoferrin, and inflammatory menu. Comparable as a niche specialty reagent company targeting clinical and research laboratories.
• FUJIFILM Wako Diagnostics: FUJIFILM Wako Diagnostics develops specialty clinical chemistry reagents including Lp(a), HbA1c, and other specialty assays that compete head-to-head with Diazyme's product portfolio. Comparable as a specialty IVD reagent manufacturer serving clinical chemistry analyzer installed bases.
• Randox Laboratories: Randox manufactures a wide portfolio of clinical chemistry, immunoassay, and specialty diagnostic reagents as well as its own benchtop analyzers — directly comparable to Diazyme's DZ-Lite c270 plus reagent menu strategy. Targets similar clinical laboratory and hospital customers with recurring consumable revenue.

Broad incumbents

• Roche Diagnostics: Roche Diagnostics is the global market leader in clinical chemistry and immunoassay analyzers/reagents with broad menus including cardiac, sepsis, metabolic, and specialty markers that overlap Diazyme's portfolio. Represents the dominant incumbent benchmark for clinical chemistry reagent share and bundled instrument placement.
• Beckman Coulter Diagnostics (Danaher): Beckman Coulter manufactures the AU series of clinical chemistry analyzers — the platform against which several Diazyme assays (e.g., Colorimetric Lithium) are validated — and offers an extensive general/specialty chemistry reagent menu. Comparable as a broad IVD incumbent and channel for Diazyme's third-party-analyzer reagent business.
• Abbott Diagnostics: Abbott Diagnostics operates the Architect/Alinity clinical chemistry and immunoassay platforms with broad specialty reagent menus overlapping Diazyme's cardiac, metabolic, and inflammatory markers. Comparable as a broad IVD incumbent whose installed analyzers compete with Diazyme's specialty reagent placement.

Emerging players

• Quanterix: Quanterix is an emerging neurology biomarker company developing ultra-sensitive pTau, NfL, and Aβ assays for Alzheimer's and neurodegeneration diagnostics — directly comparable to Diazyme's emerging neurology CLIA pipeline. Shares the same target market opportunity (blood-based Alzheimer's diagnostics) using proprietary high-sensitivity assay technology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/diazyme-laboratories

Compliance18 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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

M&A2 records

Investments

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

Frequently asked questions about Diazyme Laboratories