Chembio Diagnostic Systems Inc.

What Chembio Diagnostic Systems Inc. does

Chembio Diagnostic Systems, Inc. is a US-based diagnostics company that develops, manufactures, and commercializes proprietary rapid point-of-care tests for infectious diseases. The company is headquartered in Medford, New York, and operates as a wholly owned subsidiary of France-based Biosynex Group (Euronext Growth Paris: ALBIO), following Biosynex's approximately $17.2 million acquisition in April 2023. Chembio's product portfolio is built on its patented Dual Path Platform (DPP) technology, a proprietary chromatographic immunoassay architecture that allows multiplex detection of up to 8 biomarkers, delivers results in approximately 15 minutes, and is not affected by the Hook Effect that limits conventional lateral flow assays. The portfolio spans HIV (DPP HIV 1/2 Assay, HIV 1/2 STAT-PAK, SURE CHECK HIV 1/2, STAT-VIEW HIV, HIV Self-Tests), syphilis (DPP HIV-Syphilis dual test, DPP Syphilis Screen & Confirm, DPP Syphilis TnT Assay in FDA review), tropical diseases (Chagas, Zika, Ebola, multiplex ZCD), COVID-19 (Advin, DPP SARS-CoV-2), and veterinary TB (Elephants, Cervids), supported by DPP Micro Reader and Micro Reader II handheld analyzers.

The company monetizes primarily through one-time sales of test kits and handheld analyzers distributed via major medical wholesalers (McKesson, Henry Schein, Fisher Scientific, Medline) and group purchasing organizations (Afaxys GPO), with end customers including US healthcare providers, public health clinics, maternal and women's health settings, consumer/OTC channels, and global health programs in low- and middle-income countries. Revenue is supplemented by non-dilutive grant funding from the US CDC ($3.2M, 2024), Bill & Melinda Gates Foundation ($1.5M in 2024 and $0.5M in 2025), and CARB-X ($1.8M, 2026), which fund the development pipeline for congenital syphilis, preeclampsia, and typhoid fever diagnostics. The FASTPACK IP quantitative immunoassay analyzer is commercialized through the Qualigen Diagnostics subsidiary, extending the franchise into women's health and hormone testing. The company holds 11 issued US patents, 14 pending US applications, and 11 international patents, and has secured FDA approvals, CLIA Waivers, FDA Breakthrough Device designations, WHO Prequalification, CE Marks, and USDA licensing across the portfolio.

Name

Chembio Diagnostic Systems Inc.

Legal name

Chembio Diagnostic Systems, Inc.

Website

https://chembio.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

101–250 employees

Short description

Chembio Diagnostic Systems Inc. is a US-based developer and manufacturer of rapid point-of-care infectious disease diagnostic tests built on its proprietary Dual Path Platform (DPP) technology, serving healthcare providers, public health clinics, and global health programs under Biosynex Group ownership.

Ownership category

akta.pro rank

Product category

Point-of-Care Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL)

akta.pro secondary industries

Clinical Chemistry & Immunoassay Systems (HLAHAAAA), Pregnancy, Fertility & Women’s Health Rapid Tests (hCG, ovulation, vaginal infection) (HLAHAOAF)

Keywords

• Point-of-care diagnostics
• Rapid immunoassay tests
• Infectious disease testing
• HIV screening products
• In-vitro diagnostics manufacturing

Headquarters

HQ city

Medford

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Operations

Revenue model

1. Rapid Diagnostic Test Products: Chembio generates revenue through the sale of rapid point-of-care diagnostic test kits and handheld analyzers. Products include HIV tests, syphilis tests, tropical disease tests, respiratory disease tests, and veterinary diagnostic tests. Revenue is primarily one-time product sales with no recurring subscription component.
2. FASTPACK IP System (Qualigen): Compact automated quantitative immunoassay analyzer generating revenue from sale of single-use test pouches containing integrated reagents. Delivers laboratory-quality quantitative results in approximately 12 minutes from serum or plasma samples for women's health, hormone monitoring, and wellness testing.

Pricing tiers

Go-to-market motion3 records

Distribution channels7 records

Marketing channels6 records

Core offering

Chembio Diagnostic Systems, Inc. develops, manufactures, licenses, and markets proprietary rapid point-of-care diagnostic tests built on its patented Dual Path Platform (DPP) chromatographic immunoassay technology. The portfolio spans FDA-approved, CLIA-waived, CE-marked, and WHO-prequalified HIV, syphilis, tropical disease (Chagas, Zika, Ebola, ZCD multiplex), and respiratory (COVID-19) tests, complemented by DPP Micro Reader handheld analyzers, veterinary TB tests, and the FASTPACK IP quantitative immunoassay system sold through the Qualigen Diagnostics subsidiary.

Product overview

Chembio Diagnostic Systems Inc. operates as a portfolio of rapid point-of-care diagnostic products built on its proprietary Dual Path Platform (DPP) technology. The core product line includes HIV tests (DPP HIV 1/2 Assay, HIV 1/2 STAT PAK, SURE CHECK HIV 1/2 Assay, SURE CHECK HIV Self-Test, STAT-VIEW HIV 1/2 Assay, STAT-VIEW HIV/VIH Self-Test), syphilis tests (DPP HIV-Syphilis dual test, DPP Syphilis Screen & Confirm, DPP Syphilis TnT Assay in development), tropical disease tests (Chagas STAT PAK, DPP Zika IgM/IgG, DPP Zika IgM, DPP ZCD IgM/IgG multiplex), and respiratory tests (Advin COVID-19 Antigen, DPP SARS-CoV-2 Antigen, DPP SARS-CoV-2 IgM/IgG). Supporting hardware includes DPP Micro Reader and DPP Micro Reader II handheld analyzers. Veterinary products include DPP VetTB Assays for Elephants and Cervids. The company also commercializes the FASTPACK IP System through its Qualigen Diagnostics subsidiary. The company was acquired by Biosynex SA in April 2023.

Differentiator

Problem solved

Functional benefit

Brands

• DPP (Dual Path Platform): Proprietary chromatographic immunoassay technology platform for rapid, point-of-care diagnostic testing
• STAT-PAK
• SURE CHECK
• STAT-VIEW
• DPP Micro Reader
• DPP Micro Reader II

Products and services

• DPP HIV-Syphilis First and only FDA-approved, CLIA-waived rapid point-of-care dual test detecting antibodies to HIV 1/2 and Treponema pallidum in fingerstick whole blood, venous whole blood, or plasma; uses patented DPP technology with >99% sensitivity for HIV and >94% for T. pallidum and 15-minute results.
• DPP HIV 1/2 Assay FDA-approved, CLIA-waived rapid point-of-care test detecting antibodies to HIV-1 and HIV-2 in oral fluid, fingerstick blood, venous whole blood, serum, and plasma using patented DPP technology; WHO prequalified for international use.
• HIV 1/2 STAT-PAK Assay FDA-approved, CLIA-waived rapid point-of-care assay for HIV-1 and HIV-2 antibodies in fingerstick whole blood, venous whole blood, serum, or plasma using 5 microliter sample volume; 99.7% sensitivity and 99.9% specificity; also WHO prequalified and the only HIV test that exceeds WHO performance thresholds with 100% sensitivity and 100% specificity.
• SURE CHECK HIV 1/2 Assay FDA-approved, CLIA-waived rapid point-of-care test detecting HIV-1 and HIV-2 antibodies in fingerstick whole blood, venous whole blood, serum, and plasma; uses 2.5 microliter sample volume in an all-in-one barrel design; 99.7% sensitivity and 99.9% specificity; WHO prequalified internationally.
• SURE CHECK HIV Self-Test CE-marked single-use in-vitro diagnostic self-test for detection of HIV-1 and HIV-2 antibodies in fingerstick whole blood; uses only 2.5 microliters of blood with results in minutes; over 13 million tests used professionally; 100% sensitivity and 99.8% specificity; received FDA Breakthrough Device designation in June 2025 for over-the-counter use.
• DPP Syphilis Screen & Confirm CE-marked rapid point-of-care test that simultaneously and separately detects treponemal and nontreponemal antibodies for syphilis screening and confirmation; provides 15-minute results enabling immediate treatment decisions with 96.5% treponemal sensitivity and 99.7% nontreponemal sensitivity; developed under a $3.2 million CDC contract.
• STAT-VIEW HIV 1/2 Assay CE-marked rapid point-of-care test for detection of HIV-1 and HIV-2 antibodies in fingerstick whole blood, venous whole blood, serum, and plasma; delivers results in 15 minutes with 100% sensitivity and 99.8% specificity.
• STAT-VIEW HIV/VIH Self-Test CE-marked rapid, single-use in-vitro diagnostic self-test for detection of HIV-1 and HIV-2 antibodies in fingerstick whole blood; provides results in minutes; positive results must be confirmed by a healthcare professional.
• Chagas STAT-PAK Assay Single-use immunochromatographic rapid test for detection of antibodies to Trypanosoma cruzi (Chagas disease) in fingerstick whole blood, venous whole blood, serum, or plasma; delivers results in 15 minutes with minimal training required and 99.8% sensitivity / 100% specificity.
• DPP Zika IgM/IgG System Rapid point-of-care test for detection of IgM and IgG antibodies to Zika virus in fingerstick blood, whole blood, serum, and plasma; delivers results in 15 minutes using the DPP Micro Reader for objective result interpretation with excellent agreement to laboratory EIAs.
• DPP Zika IgM System FDA-cleared 15-minute rapid test for detection of Zika virus IgM antibodies in fingerstick whole blood, EDTA venous whole blood, EDTA plasma, and serum; detects IgM antibodies from 4 days up to 12 weeks post-onset of symptoms.
• DPP Ebola Antigen System 15-minute rapid test for detection of Ebola Virus-specific antigen in fingerstick whole blood, EDTA venous whole blood, and EDTA plasma; granted Emergency Use Authorization (EUA) by FDA.
• DPP ZCD IgM/IgG System World's first CE-marked multiplex point-of-care rapid test for differential diagnosis of Zika, Chikungunya, and Dengue (ZCD); differentiates active and past infections through IgM and IgG antibody detection from a 10 microliter sample with results in 15 minutes.
• Advin COVID-19 Antigen Test @Home FDA EUA-authorized lateral flow immunoassay device for qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 using a non-invasive anterior nasal swab with results in 10 minutes; available in kits of 1, 2, and 25 tests.
• DPP SARS-CoV-2 Antigen System Rapid test for detection of nucleocapsid protein antigen to SARS-CoV-2 in nasal swab specimens; delivers results in 20 minutes with room temperature storage and visual or DPP Micro Reader/Micro Reader II interpretation; ANVISA approved for Brazilian distribution.
• DPP SARS-CoV-2 IgM/IgG System CE-marked rapid serology test for detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, and plasma; delivers results in 15 minutes from a 15 microliter sample.
• DPP Micro Reader Handheld point-of-care device enabling objective test result reading for SARS-CoV-2 and other DPP tests; fits in the palm of the hand, minimizes human errors from visual interpretation, is maintenance-free, single-button operation with minimal training required.
• DPP Micro Reader II CE-marked handheld analyzer delivering automated DPP test results in 15-20 seconds; two-step operation (insert test device, press button) with Micro USB connection; runs on AA batteries or via power outlet.
• DPP VetTB Assay for Elephants Single-use immuno-chromatographic rapid test for detection of antibodies to Mycobacterium tuberculosis and M. bovis in African and Asian elephants; 15-minute test using 5 microliter serum/plasma or 10 microliter whole blood; USDA licensed with 100% sensitivity and 100% specificity for both elephant species.
• DPP VetTB Assay for Cervids Single-use immuno-chromatographic rapid test for detection of antibodies to Mycobacterium bovis in elk/red deer, fallow deer, and white-tailed deer; requires a 5 microliter serum sample; USDA licensed.
• FASTPACK IP System Compact, fully automated quantitative immunoassay analyzer designed for decentralized clinical settings; delivers laboratory-quality quantitative results in approximately 12 minutes from serum or plasma samples for women's health, hormone monitoring, and pregnancy confirmation; commercialized through the Qualigen Diagnostics subsidiary under Biosynex Group and available via the Afaxys GPO.

Quantifiable outcome

• DPP HIV-Syphilis achieved >99% sensitivity for HIV and >94% for T. pallidum
• +6 more outcomes

Named customers5 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Afaxys GPOcoreChannel Partner/ Reseller/ Distributor · 20 March 2026Qualigen Diagnostics (part of Biosynex Group) announced agreement with Afaxys GPO to expand access to FASTPACK IP quantitative hCG testing in women's health settings across the United States. Afaxys is a specialized purchasing organization serving public health providers.
• Reszon Diagnostics InternationalminorChannel Partner/ Reseller/ Distributor · 1 January 2024Agreement for Reszon Diagnostics International to manufacture Chembio's HIV 1/2 STAT-PAK Assay at Chembio Diagnostics Malaysia Facility, expanding manufacturing capacity in the Asia-Pacific region.
• Biosynex SAcoreStrategic or Co-development Partner · 1 April 2023In April 2023, Biosynex SA acquired Chembio Diagnostics, Inc. for approximately $17.2 million to expand its North American presence and point-of-care diagnostics portfolio. Chembio operates as a wholly owned subsidiary of Biosynex, contributing to the group's global diagnostics strategy with operations in the US, Europe, and Asia.

Scale indicators10 records

Expansion highlights6 records

Direct peers

• OraSure Technologies: OraSure Technologies is the most direct competitor to Chembio, particularly in HIV rapid and at-home self-testing with its OraQuick ADVANCE HIV and OraQuick In-Home HIV Test. Both companies compete for CLIA-waived point-of-care HIV and infectious disease customers and pursue the OTC HIV self-test opportunity in the US.
• Trinity Biotech: Trinity Biotech develops and manufactures rapid diagnostic tests for infectious diseases including HIV, syphilis, and tropical diseases, with overlapping customer segments in public health laboratories and emerging markets. It is one of the closest mid-cap direct peers to Chembio in HIV/syphilis rapid testing.
• bioLytical Laboratories: bioLytical Laboratories (INSTI) is a direct competitor in rapid HIV testing, including the INSTI HIV-1/HIV-2 Antibody Test and INSTI HIV Self-Test. Both companies target CLIA-waived POC and self-test channels and pursue WHO Prequalification for LMIC markets.

Broad incumbents

• Abbott Rapid Diagnostics (Alere): Abbott (through its Alere acquisition) sells the Determine HIV, Syphilis, and HBsAg rapid test lines, making it Chembio's largest broad incumbent peer. Abbott competes across Chembio's core HIV, syphilis, and emerging infectious disease POC categories with deeper R&D and global sales reach.
• QuidelOrtho: QuidelOrtho is a major diagnostics incumbent with broad rapid test portfolios (Sofia SARS, QuickVue, Triage) sold through the same McKesson, Henry Schein, and Fisher Scientific channels as Chembio. It competes with Chembio in rapid infectious disease POC testing at hospitals, urgent care, and physician offices.
• Mylan / Viatris (rapid diagnostics exposure): Viatris (which absorbed Mylan and parts of the Upjohn business) competes in HIV self-testing in international markets through donated and commercial channels via partners, overlapping with Chembio's WHO Prequalified HIV self-test portfolio.
• Hologic: Hologic's diagnostics division (Aptima, Panther) competes in women's health and infectious disease testing, overlapping with Chembio's maternal health and syphilis screening portfolio. It is a larger incumbent pursuing similar POC expansion strategies.

Emerging players

• SD Biosensor: SD Biosensor is a Korean rapid diagnostics manufacturer with extensive HIV, syphilis, and tropical disease POC products that compete directly with Chembio in international tenders and emerging markets. It has rapidly scaled global share via WHO Prequalified product lines.
• InBios International: InBios International is a Seattle-based rapid diagnostics developer focused on emerging infectious diseases (Zika, Chikungunya, dengue, Ebola, Leptospira) that overlap with Chembio's tropical disease portfolio. Both compete for CDC, NIH, and BARDA grant-funded development programs.
• Cepheid (Danaher): Cepheid (a Danaher operating company) sells the GeneXpert molecular diagnostic platform that competes for hospital and clinic infectious disease testing budgets alongside Chembio's rapid immunoassays. While molecular vs immunoassay-based, both target rapid infectious disease diagnosis at POC and central labs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/chembio
• Facebookfacebook.com/Chembio
• LinkedInlinkedin.com/company/chembio-diagnostic-systems-inc.

Compliance17 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries5 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A1 record

Investments

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

Frequently asked questions about Chembio Diagnostic Systems Inc.