Reagen
REAGEN, Inc. is a San Diego-based IVD diagnostics manufacturer founded in 2012, selling immunochromatographic rapid test kits, real-time PCR kits, and ELISA kits for human infectious disease, food safety, and veterinary applications directly to healthcare providers, public health agencies, and laboratories across 140+ countries at roughly $999 per kit.
- Company typePrivate
- Founded2012
- HeadquartersSan Diego, United States
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Reagen does
REAGEN, Inc. is a San Diego, California-based biotechnology company founded in 2012 that manufactures and distributes in vitro diagnostic (IVD) rapid test kits, molecular diagnostic PCR kits, ELISA kits, colloidal gold lateral flow strips, and supporting raw materials for antigen and antibody production. Its core technology platform rests on immunochromatographic assays (colloidal gold conjugates and latex microsphere-based detection) and Taqman-based real-time fluorescence PCR. The portfolio spans human infectious disease diagnostics (respiratory pathogens, hepatitis, HIV, syphilis, dengue, typhoid, tuberculosis, chlamydia, gonorrhea, monkeypox, hantavirus, measles, meningitis), pregnancy testing (HCG), food safety (algal toxins, veterinary drugs), and animal diagnostics, with multiplex panels detecting up to 10 respiratory pathogens in a single strip and result times of 8–15 minutes.
The company sells primarily through a direct-to-buyer B2B e-commerce channel (reagen.us), handling global fulfillment to 140+ countries with a stated ≤2-week payment-to-receipt delivery SLA, and offers one-on-one expert guidance plus on-site services. Pricing is standardized at approximately $999 per kit, with bulk/enterprise volume purchasing visible in the e-commerce cart flow. CE-certified products are stocked, and the catalog is positioned to healthcare providers and clinical laboratories as the primary segment, with secondary reach into government and public health agencies (field outbreak screening) and food-safety and veterinary industries.
Revenue is generated through one-time unit sales of diagnostic kits and PCR kits (e.g., 50–100 tests/kit) plus consumable raw materials and ancillary reagents such as the extraction-free DNA/RNA releaser. Customer evidence includes a US clinic citing doubled throughput using the 4-in-1 respiratory combo, a Southeast Asia regional hospital chain procurement officer citing batch-to-batch consistency, a public-health field screening deployment, and a third-year contract renewal from a laboratory drug-abuse panel customer. Walgreens co-branding on the website suggests a parallel US retail/home-testing channel via the 'QuadSure' branded Combo product.
Reagen firmographics
Firmographics- Name
- Reagen
- Legal name
- REAGEN, Inc.
- Website
- https://reagen.us
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- REAGEN, Inc. is a San Diego-based IVD diagnostics manufacturer founded in 2012, selling immunochromatographic rapid test kits, real-time PCR kits, and ELISA kits for human infectious disease, food safety, and veterinary applications directly to healthcare providers, public health agencies, and laboratories across 140+ countries at roughly $999 per kit.
- Ownership category
- akta.pro rank
Reagen industry classification
Industry- Product category
- In Vitro Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)
- akta.pro secondary industries
- Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Food Safety Certification Bodies (ISO 22000, FSSC 22000, BRCGS, SQF) (AFALAAAC), Reference Laboratory Testing (Clinical Pathology & Chemistry) (HLAMADAA)
Keywords
Where Reagen is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Reagen business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- IVD Rapid Test Kit Sales: One-time sale of rapid diagnostic test kits including lateral flow chromatographic immunoassays, colloidal gold strips, and immunochromatographic tests for human diseases, infectious diseases, and pregnancy detection. Revenue generated through direct e-commerce sales to healthcare providers and clinical laboratories.
- Molecular Diagnostic PCR Kit Sales: Real-time fluorescence PCR detection kits for nucleic acid detection. Includes kits for HBV, Chlamydia trachomatis, Dengue virus, Monkeypox virus, Shigella, Mycobacterium tuberculosis, and Neisseria gonorrhoeae. Sold as one-time purchases with specifications like 50 tests/kit or 100 tests/kit.
- Raw Materials and Consumables: Raw materials for antigen and antibody production, swabs, sample collection devices, and ancillary reagents like the Nucleic Acid DNA/RNA Releaser. Sold as consumable products alongside main diagnostic kits.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Standard Diagnostic Kit Pricing |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels3 records
Reagen product offering
Product offeringCore offering
REAGEN is a biotechnology company that manufactures and sells in vitro diagnostic (IVD) test kits for human disease detection, food safety, and veterinary applications. Core offerings include colloidal gold lateral flow rapid antigen test kits, real-time fluorescence PCR molecular diagnostic kits, ELISA kits, and raw materials for antigen/antibody production. Products span respiratory pathogen panels (multi-pathogen combo tests), infectious disease screening (HIV, hepatitis, syphilis, dengue, typhoid, monkeypox, hantavirus), pregnancy testing (HCG), food safety, and animal diagnostics, distributed globally with CE certification.
Product overview
REAGEN is a global biotechnology company offering a comprehensive portfolio of in vitro diagnostic (IVD) products and molecular diagnostics. The core product lines include: (1) Lateral flow rapid test kits using colloidal gold immunochromatography for point-of-care detection of human diseases including respiratory pathogens (COVID-19, influenza, RSV, adenovirus), infectious diseases (HIV, hepatitis, syphilis, dengue, typhoid), pregnancy (HCG), and emerging pathogens (monkeypox, hantavirus); (2) Real-time fluorescence PCR detection kits using Taqman technology for molecular diagnostics of pathogens including HBV, tuberculosis, chlamydia, shigella, dengue, and monkeypox; (3) Combo respiratory tests including the 4-in-1, 6-in-1, 9-in-1, and 10-in-1 multiplex antigen rapid tests for simultaneous detection of multiple respiratory pathogens; (4) Supporting products including nucleic acid release agents and sample collection swabs. The company also provides ELISA test kits, colloidal gold strips, raw materials for antigen and antibody production, food safety test kits, and animal diagnostics. Products are distributed across 140+ countries with CE certifications and 24-month shelf life for most rapid test products.
Differentiator
Problem solved
Functional benefit
Products and services
- Human Chorionic Gonadotropin (HCG) Rapid Test Kit Rapid lateral flow immunoassay for qualitative detection of HCG in women's urine for early pregnancy diagnosis, with results in 10 minutes.
- Ten Respiratory Pathogens Antigen Rapid Test Kit Immunochromatographic test using latex microspheres for qualitative detection of 10 respiratory pathogens (COVID-19, Flu A/B, RSV, ADV, MP, CP, HMPV, PIV1/3, PIV2) from nasal swab samples.
- Nine Respiratory Pathogens Antigen Rapid Test Kit Immunochromatographic test using latex microspheres for qualitative detection of 9 respiratory pathogens from nasal swab samples.
- SARS-CoV-2/RSV/ADV/Flu A/B Antigen Rapid Test Kit Immunochromatographic double-antibody sandwich assay for qualitative detection and differentiation of SARS-CoV-2, RSV, ADV, Influenza A and B, and M.Pneumoniae from nasopharyngeal swabs.
- COVID-19 & Influenza A/B Antigen Combo Double antibody sandwich rapid test for simultaneous qualitative detection of COVID-19 and Influenza A/B antigens in oropharyngeal and nasopharyngeal swab samples. 24-month shelf life.
- Measles IgG/IgM Rapid Test Kit Rapid lateral flow chromatographic immunoassay for simultaneous detection and differentiation of IgM and IgG antibodies to measles in whole blood, serum, or plasma.
- Neisseria Meningitidis IgM Antibody Rapid Test Kit Qualitative immunochromatographic assay for detection of Neisseria Meningitidis IgM antibody in serum, plasma, or whole blood for early aid in meningitis diagnosis.
- HBsAg Rapid Test Kit Rapid chromatographic immunoassay for qualitative detection of HBsAg (Hepatitis B Surface Antigen) in serum or plasma.
- Syphilis Ab Rapid Test Kit Lateral flow chromatographic immunoassay for qualitative detection of antibodies (IgG, IgM, IgA) to Treponema pallidum in serum, plasma, or whole blood.
- SARS-CoV-2 Antigen IVD Kit (Swab) In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal, oropharyngeal, and nasal swab samples using immunochromatographic method.
- SARS-CoV-2 Antigen IVD Kit (Nasal) In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2 antigen in nasal swab samples.
- Typhoid IgG/IgM Rapid Test Kit
Quantifiable outcome
- Clinic throughput doubled using 4-in-1 respiratory combo test
- +3 more outcomes
Companies that use Reagen
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
Reagen technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Reagen partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered minor.
- WalgreensminorWalgreens logo appears in customer/client section of REAGEN website, suggesting a distribution or supply relationship for diagnostic products through Walgreens retail/pharmacy channels in the US market.
- DNXminorDNX logo displayed in REAGEN client/partnership section. Nature of relationship not explicitly defined in source material.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
Reagen competitors and assessment
Company assessmentBroad incumbents
- Bio-Rad Laboratories: Bio-Rad offers a broad diagnostic and life science research portfolio including PCR reagents and immunoassay kits relevant to REAGEN's molecular diagnostics line. Competes in lab-based research and clinical PCR reagent channels at substantially larger scale.
- Abbott (Rapid Diagnostics): Abbott's Diagnostics division includes BinaxNOW, Panbio, and ID NOW rapid platforms for respiratory and infectious diseases at massive global scale with FDA approvals. Competes in the same end markets but with broader portfolio (instruments, immunoassays, molecular) and far deeper regulatory footprint.
- Becton Dickinson (BD Veritor): BD's Veritor Plus system offers rapid antigen testing for respiratory pathogens with FDA clearance and major US hospital IDN contracts. Adjacent offering with instrument-based readout; competes for the same hospital lab budget allocation as REAGEN.
- QuidelOrtho: QuidelOrtho manufactures Sofia rapid antigen tests and Triage meter-based assays with FDA clearances and broad US hospital distribution. Comparable multiplex respiratory kits but with instrumented readout platforms and much larger commercial organization.
Direct peers
- Hangzhou AllTest Biotech: AllTest is a Chinese IVD kit maker focused on colloidal gold lateral flow rapid tests for infectious disease, drug of abuse, and pregnancy with extensive OEM/ODM and direct distribution globally. Directly comparable product portfolio and competitive positioning.
- SD Biosensor: SD Biosensor (formerly Standard Diagnostics) is a Korean IVD manufacturer with nearly identical product mix — lateral flow rapid tests, multiplex respiratory panels, and export-driven distribution to 140+ countries. Closest scale and GTM comparison to REAGEN.
- ACON Laboratories: ACON is a direct competitor manufacturing rapid lateral flow IVD tests including COVID/Flu combo panels, HCG pregnancy tests, and infectious disease cassettes at similar price points with global distribution. Highly comparable on product format, channel (B2B healthcare + retail), and target buyer profile.
- Guangzhou Wondfo Biotech: Wondfo is one of the largest Chinese rapid diagnostic kit manufacturers with a comparable product line spanning infectious disease, fertility, drug of abuse, and food safety lateral flow tests. Competes head-to-head with REAGEN in emerging market tenders.
- GenBody: GenBody is a Korean IVD company specializing in rapid antigen and antibody test kits (COVID, influenza, RSV, dengue, STI) with strong export distribution to Asia, Latin America, and the Middle East. Direct overlap on multiplex respiratory and infectious disease kits.
Emerging players
- InBios International: InBios develops and manufactures rapid immunochromatographic tests for emerging and tropical infectious diseases (dengue, Zika, scrub typhus, Chagas) with CDC and BARDA partnerships. Comparable lateral flow focus on infectious disease, smaller scale and narrower geography than REAGEN.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Reagen social profiles
Digital presenceReagen financial estimates
Financial estimateRevenue estimate
Valuation estimate
Reagen leadership team
Management profileNumber of profiles
Reagen funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Reagen 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 Reagen
What does Reagen do?
REAGEN is a biotechnology company that manufactures and sells in vitro diagnostic (IVD) test kits for human disease detection, food safety, and veterinary applications. Core offerings include colloidal gold lateral flow rapid antigen test kits, real-time fluorescence PCR molecular diagnostic kits, ELISA kits, and raw materials for antigen/antibody production. Products span respiratory pathogen panels (multi-pathogen combo tests), infectious disease screening (HIV, hepatitis, syphilis, dengue, typhoid, monkeypox, hantavirus), pregnancy testing (HCG), food safety, and animal diagnostics, distributed globally with CE certification.
Is Reagen a public or private company?
Reagen is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Reagen founded?
Reagen was founded in 2012. It employs 101 to 250 people.
Where is Reagen based?
Reagen is headquartered in San Diego, United States, in the North America region.
How does Reagen make money?
Three revenue lines are on record. IVD Rapid Test Kit Sales are the primary driver. The others are molecular Diagnostic PCR Kit Sales and raw Materials and Consumables.
Who are Reagen's main competitors?
Broad incumbents on record are Bio-Rad Laboratories, Abbott (Rapid Diagnostics), Becton Dickinson (BD Veritor) and QuidelOrtho. Direct peers are Hangzhou AllTest Biotech, SD Biosensor, ACON Laboratories, Guangzhou Wondfo Biotech and GenBody. InBios International is listed as an emerging player.
Does Reagen have an API?
No public API is recorded for Reagen.
What industry is Reagen in?
Reagen's product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument), with a secondary code of HLAGAIAI, Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes). Its NAICS code is 325413 and its SIC code is 2835.