Reagen

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.

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

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

• In vitro diagnostics
• Molecular diagnostic kits
• Lateral flow assays
• Rapid antigen testing
• Food safety diagnostics

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. 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.
2. 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.
3. 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

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core 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

Named customers4 records

Segments3 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

Two partnerships are on record, tiered minor.

• WalgreensminorChannel Partner/ Reseller/ DistributorWalgreens 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.
• DNXminorOthersDNX 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

Broad 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

• Xx.com/FeedReagen
• LinkedInlinkedin.com/company/reagen-inc

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 Reagen