IVD Research
- Company typePrivate
- Founded1996
- HeadquartersCarlsbad, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What IVD Research does
IVD Research, Inc. is a privately held Contract Development and Manufacturing Organization (CDMO) founded in 1996 and headquartered in Carlsbad, California, specializing in in vitro diagnostics for human and veterinary applications. The company develops and manufactures diagnostic test kits across three core technology platforms — Microwell ELISA, Lateral Flow Immunoassays, and Direct Fluorescent Antigen (DFA) detection — targeting global pathogens including parasites (Cryptosporidium, Giardia, E. histolytica, Strongyloides, Toxocara, Schistosoma, Fasciola) and bacteria (Legionella, Campylobacter, E. coli). Its product portfolio includes FDA 510(k)-cleared DFA kits and a range of stool, urine, and serum antigen and antibody detection assays, complemented by an exclusive license to a novel Scripps Research onchocerciasis biomarker for river blindness monitoring.
The company generates revenue through two principal streams: contract manufacturing services, in which it provides turnkey R&D-through-commercialization support to biotech and diagnostics clients on a custom-tailored, multi-year contract basis; and OEM product sales, in which it distributes its own branded diagnostic kits through direct sales and global distribution partners. Manufacturing is conducted at an ISO 13485:2016 certified, FDA-registered facility operating under cGMP, with sister company SafePath Laboratories providing complementary USDA-licensed biologics manufacturing for veterinary diagnostics. Advanced production equipment, notably the BioDot XYZ3210 dispensing platform, supports higher-volume throughput.
In December 2025, IVD Research was acquired by KVP International, with SafePath-IVD continuing as KVP's research, development, and manufacturing partner. The company sells primarily through enterprise field sales, industry trade show presence (AACC, Medica), and direct B2B channels targeting biotech and diagnostics manufacturers in need of regulated, specialized contract manufacturing capacity.
IVD Research firmographics
Firmographics- Name
- IVD Research
- Legal name
- IVD Research, Inc.
- Website
- https://ivdresearch.com
- Company type
- Private
- Founded year
- 1996
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Ownership category
- akta.pro rank
IVD Research industry classification
Industry- Product category
- In Vitro Diagnostics Contract Manufacturing
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Scientific Research and Development Services (5417)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)
- akta.pro secondary industries
- Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Anatomic Pathology & Histology/Cytology IVD (Tissue Diagnostics) (HLAHAAAE)
Keywords
Where IVD Research is headquartered
LocationHeadquarters
- HQ city
- Carlsbad
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
IVD Research business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales
Revenue model
- Contract Manufacturing Services: Custom-tailored contract manufacturing services providing complete turnkey solutions for product commercialization needs. Services span from R&D through commercialization, handling everything from small batches for clinical trials to large medical device orders. Customers can use both IVD-supplied and customer-supplied materials.
- OEM Product Sales: Sale of IVD's own line of high-quality diagnostic tests under OEM services, allowing customers to expand their product lines quickly with products including ELISA kits, lateral flow tests, and DFA products.
- Licensing Royalties: Revenue from licensing novel biomarkers and diagnostic technologies, such as the onchocerciasis biomarker licensed from Scripps Research, potentially generating royalty income from approved products.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom contract manufacturing packages tailored to customer needs |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels3 records
IVD Research product offering
Product offeringCore offering
IVD Research is a Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and markets in vitro diagnostic (IVD) test kits and provides turnkey contract manufacturing services for human and veterinary diagnostics. The company produces ELISA microwell kits, lateral flow immunoassays, and Direct Fluorescent Antigen (DFA) detection kits for global pathogens, while offering full R&D-through-commercialization manufacturing services from an ISO 13485-certified, FDA-registered cGMP facility in Carlsbad, California.
Product overview
IVD Research is a Contract Development and Manufacturing Organization (CDMO) specializing in in vitro diagnostics for human and veterinary applications. The company's product portfolio consists of three diagnostic technology platforms: (1) Lateral Flow Test Kits providing rapid point-of-care results in 10-15 minutes for field and clinical settings; (2) Microwell ELISA Test Kits providing accurate laboratory-based detection from stool, urine, and serum samples; and (3) Direct Fluorescent Antigen (DFA) Test Kits for microscopy-based simultaneous detection and differentiation of parasites. Key products include pathogen-specific test kits for Cryptosporidium, Giardia, E. histolytica/dispar, Legionella, Fasciola, Strongyloides, Toxocara, Schistosoma, and Adenovirus. The company also offers turnkey contract manufacturing services supporting customers from R&D through product commercialization, leveraging an ISO 13485 certified facility with FDA registration and cGMP compliance.
Differentiator
Problem solved
Functional benefit
Products and services
- Contract Manufacturing Services (CDMO) Full-service CDMO offering custom-tailored contract manufacturing for diagnostic products from R&D through commercialization, including small clinical-trial batches and large medical-device orders under cGMP, using customer-supplied or IVD-supplied materials.
- Cryptosporidium Stool Antigen Detection Microwell ELISA 96-well microwell ELISA kit for accurate detection of Cryptosporidium antigens in human stool samples using antigen-capture immunoassay, with up to 12-month shelf life.
- Giardia/Cryptosporidium Combo Stool Antigen Detection Microwell ELISA 96-well microwell ELISA kit for simultaneous detection of Giardia and Cryptosporidium antigens in human stool samples using an antibody sandwich immunoassay format.
- Giardia Stool Antigen Detection Microwell ELISA 96-well microwell ELISA kit providing accurate detection of Giardia antigens in human stool samples with up to 12-month shelf life.
- E. histolytica/dispar Stool Antigen Detection Microwell ELISA Microwell ELISA kit detecting Entamoeba histolytica/dispar antigens in human stool samples and distinguishing between pathogenic and non-pathogenic strains.
- Entamoeba histolytica Serum Antibody Detection Microwell ELISA Serum antibody detection microwell ELISA kit identifying Entamoeba histolytica antibodies in human serum samples.
- Fasciola Serum Antibody Detection Microwell ELISA Serum antibody detection microwell ELISA kit for diagnosing fascioliasis in early-stage infections via Fasciola parasite antibodies.
- Strongyloides Serum Antibody Detection Microwell ELISA Serum antibody detection microwell ELISA kit for accurate detection of Strongyloides antibodies in human serum samples in a 96-well format.
- Toxocara Serum Antibody Detection Microwell ELISA Serum antibody detection microwell ELISA kit detecting Toxocara roundworm antibodies in human serum samples.
- Schistosoma Serum Antibody Detection Microwell ELISA Serum antibody detection microwell ELISA kit for Schistosoma parasite antibodies, most accurate 6-8 weeks post-infection.
- Legionella Urinary Antigen Microwell ELISA ELISA kit for detection of Legionella antigens in urine samples to support diagnosis of Legionnaire's disease.
- Legionella Urinary Antigen Detection Lateral Flow Rapid lateral flow immunoassay kit detecting Legionella antigens in human urine samples, delivering results in 15 minutes in a 20-test kit format.
- Cryptosporidium Stool Antigen Detection Lateral Flow Rapid lateral flow immunoassay detecting Cryptosporidium antigens in human stool samples with results in 10 minutes.
- Giardia Stool Antigen Detection Lateral Flow Rapid lateral flow immunoassay kit detecting Giardia antigens in human stool samples in a 20-test kit format with 12-month shelf life.
- Cryptosporidium/Giardia Fecal Direct Fluorescent Antigen (DFA) Detection Kit Direct immunofluorescence assay kit for simultaneous detection and differentiation of Cryptosporidium and Giardia parasites in stool samples based on morphology; 510(k)-cleared for sale in the United States.
Quantifiable outcome
- Faster production and delivery times through BioDot XYZ3210 platform capable of dispensing on up to 8 surfaces simultaneously instead of 1
- +2 more outcomes
Companies that use IVD Research
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles3 records
IVD Research technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
IVD Research partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and minor.
- Scripps ResearchcoreIVD Research licensed a novel biomarker for onchocerciasis (river blindness) from Scripps Research in La Jolla, California. The reagent, developed by Kim Janda, PhD's laboratory, enables clinicians to monitor active infections and track elimination progress in patients. River blindness afflicts an estimated 18 million people with 120 million at risk globally.
- SafePath LaboratoriescoreSafePath Laboratories is IVD Research's sister company and serves as their R&D, development, and manufacturing partner. SafePath holds a USDA Licensed Biologics Manufacturing License and USDA Permittee status, complementing IVD's FDA and ISO certifications.
- StarFish MedicalminorStarFish Medical is a customer that utilized IVD Research's assay development services for an out-of-the-ordinary assay format. They provided a testimonial praising IVD's knowledge, professionalism, and responsiveness to demanding timelines.
Scale indicators4 records
Recent moves7 records
Expansion highlights5 records
IVD Research competitors and assessment
Company assessmentBroad incumbents
- Meridian Bioscience (now part of Revvity): Established IVD manufacturer and CDMO with a broad diagnostics portfolio including immunoassays for infectious disease. Comparable to IVD Research in offering diagnostic reagents and contract manufacturing services, though at significantly larger scale and broader scope.
- QuidelOrtho: Large diversified IVD manufacturer with broad infectious disease, immunoassay, and lateral flow product portfolios. Overlaps with IVD Research's technology platforms (ELISA, lateral flow) and contract manufacturing capabilities at materially larger scale.
- Bio-Techne: Major life sciences tools and diagnostics company with IVD-grade reagents, ELISA kits, and contract manufacturing services. Comparable to IVD Research's reagent manufacturing and OEM capabilities, though operating at much larger scale across multiple scientific verticals.
- Eurofins Scientific: Global CDMO and testing services conglomerate with significant IVD contract manufacturing capabilities. Comparable to IVD Research in CDMO service model and IVD product development, though operating at vastly larger scale and geographic footprint.
- Charles River Laboratories: Large CDMO offering contract development and manufacturing for biologics, diagnostics, and cell/gene therapy. Comparable to IVD Research in the CDMO business model and regulated manufacturing (cGMP) capabilities, though focused more broadly across life sciences.
Direct peers
- Trinity Biotech: Specialty IVD manufacturer focused on immunoassays, ELISA kits, and diagnostic tests for infectious and parasitic diseases. Closely comparable to IVD Research in technology platform (ELISA), pathogen focus (parasites), and CDMO-style contract development services.
- InBios International: Specialty IVD company developing FDA-cleared diagnostic kits for infectious diseases including parasitic, fungal, and tropical pathogens. Direct comparable to IVD Research's niche focus on parasitic disease diagnostics and ELISA/lateral flow product formats.
- Savyon Diagnostics: Israel-based IVD manufacturer specializing in immunoassay kits for infectious and parasitic diseases with both OEM and proprietary product lines. Comparable to IVD Research in CDMO/OEM model and ELISA-based diagnostic focus.
- ZeptoMetrix (Antylia Scientific): Specialty infectious disease diagnostics and quality control materials manufacturer. Comparable to IVD Research in IVD reagents, infectious disease focus, and contract manufacturing services for diagnostic developers.
Emerging players
- Coris BioConcept: Belgian specialty IVD developer focused on rapid lateral flow tests for respiratory, gastrointestinal, and infectious disease pathogens. Comparable to IVD Research in lateral flow technology platform and infectious disease diagnostic focus, though at a smaller scale and different geographic base.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
IVD Research social profiles
Digital presenceIVD Research compliance and trust
Trust signalCompliance3 records
IVD Research financial estimates
Financial estimateRevenue estimate
Valuation estimate
IVD Research leadership team
Management profileNumber of profiles
Profiles6 records
IVD Research funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
IVD Research M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about IVD Research
What does IVD Research do?
IVD Research is a Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and markets in vitro diagnostic (IVD) test kits and provides turnkey contract manufacturing services for human and veterinary diagnostics. The company produces ELISA microwell kits, lateral flow immunoassays, and Direct Fluorescent Antigen (DFA) detection kits for global pathogens, while offering full R&D-through-commercialization manufacturing services from an ISO 13485-certified, FDA-registered cGMP facility in Carlsbad, California.
Is IVD Research a public or private company?
IVD Research is a private company. It is classified as corporate owned and is currently operating.
When was IVD Research founded?
IVD Research was founded in 1996. It employs 11 to 50 people.
Where is IVD Research based?
IVD Research is headquartered in Carlsbad, United States, in the North America region.
How does IVD Research make money?
Three revenue lines are on record. Contract Manufacturing Services are the primary driver. The others are OEM Product Sales and licensing Royalties.
Who are IVD Research's main competitors?
Broad incumbents on record are Meridian Bioscience (now part of Revvity), QuidelOrtho, Bio-Techne, Eurofins Scientific and Charles River Laboratories. Direct peers are Trinity Biotech, InBios International, Savyon Diagnostics and ZeptoMetrix (Antylia Scientific). Coris BioConcept is listed as an emerging player.
Does IVD Research have an API?
No public API is recorded for IVD Research.
What industry is IVD Research in?
IVD Research's product category is In Vitro Diagnostics Contract Manufacturing. Its primary akta.pro industry code is HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument), with a secondary code of HLAGABAK, Clinical Trial Material (CTM) Manufacturing & Supply CDMO. Its NAICS code is 325413 and its SIC code is 2835.