Name

ACON Biotech

Legal name

ACON Biotech (Hangzhou) Co., Ltd.

Website

https://aconbio.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

11–50 employees

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), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industries

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Point-of-Care & Decentralized Trial Testing Services (HLAGAEAK)

Keywords

• In vitro diagnostics
• Rapid antigen tests
• Point-of-care testing
• Molecular diagnostics
• Lateral flow immunoassays

Headquarters

HQ city

Hangzhou

HQ country

China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Point-of-Care Testing Devices and Consumables: Sale of handheld diagnostic meters and test strips/consumables for point-of-care testing including hemoglobin, cholesterol, PT/INR, and liver function tests. Devices are sold as one-time purchases with recurring consumable revenue from test strips.
2. Rapid Test Products: Sale of lateral flow rapid test kits for infectious diseases (COVID-19, HIV, hepatitis, monkeypox), fertility (pregnancy, ovulation), and bio-markers (troponin, fecal occult blood). One-time use consumable tests sold in kits.
3. Molecular Diagnostics Products: Sale of real-time PCR systems, nucleic acid extraction instruments and kits, and PCR test kits for hepatitis, HIV, HPV, respiratory infections, and genetic testing. Includes both instrument hardware and reagent consumables.
4. Fluorescent Immunoassay (FIA) Products: Sale of FIAflex fluorescent immunoassay analyzer and associated test cassettes for various analytes including COVID-19 antigen, influenza, dengue, and allergen-specific IgE tests.

Go-to-market motion2 records

Distribution channels5 records

Marketing channels4 records

Core offering

ACON Biotech manufactures and sells in vitro diagnostic (IVD) products including rapid antigen/antibody test kits (Flowflex and ACON brands), point-of-care testing (POCT) devices such as hemoglobin and cholesterol analyzers, fluorescent immunoassay analyzers (FIAflex), real-time PCR systems and reagents (Promotor), and urinalysis analyzers and reagent strips (Mission). Its products serve both professional healthcare settings (hospitals, clinics, and laboratories) and the consumer self-testing market, distributed to more than 150 countries through subsidiaries, distributors, and direct sales channels.

Product overview

ACON Biotech offers a comprehensive portfolio of in vitro diagnostic products organized across five main categories: POCT (Point-of-Care Testing), Urinalysis, Immunoassay, Molecular Diagnostics, and COVID-19/Respiratory Disease testing. The POCT division includes hematology analyzers (Mission HA-360, Quik-Check HA-360), hemoglobin testing systems (Mission HemoPro, Mission Plus Hb, Mission Ultra Hb, Mission Hb), cholesterol monitoring systems (Mission Cholesterol Monitoring System, Mission Ultra), PT/INR monitoring, and dry chemistry analyzers (Mission C-100). The Urinalysis line features the U60, U500, and U120 Smart urine analyzers with corresponding reagent strips and controls. Immunoassay products include the FIAflex Fluorescent Immunoassay System with various FIA tests (SARS-CoV-2, Dengue, Allergen-specific IgE, Influenza A/B), rapid tests (SARS-CoV-2, HIV, hCG, LH, Troponin I, FOB, Monkeypox), and Foresight Allergen detection kits. Molecular Diagnostics offers the Promotor 960 Real-Time PCR System, NES-32 Nucleic Acid Extraction System, and PCR test kits for SARS-CoV-2, Hepatitis, HIV, HPV, TB, and Monkeypox. The COVID-19 and Respiratory Disease line includes Flowflex antigen rapid tests (including FDA EUA home test and CE self-test versions), FIAflex FIA tests, and Promotor sample collection and RT-PCR kits. The company was founded in 1995 and sells products in over 150 countries.

Differentiator

Problem solved

Functional benefit

Brands

• Flowflex: Rapid test products including SARS-CoV-2 Antigen Rapid Test, COVID-19 Home Test, and other rapid diagnostic tests
• Mission
• Promotor
• FIAflex
• Quik-Check
• Foresight
• Distinct
• CentriVet

Products and services

• Flowflex SARS-CoV-2 Antigen Rapid Test Lateral flow rapid antigen test for the qualitative detection of SARS-CoV-2 nucleocapsid protein from nasal or saliva specimens, intended for professional point-of-care use.
• Flowflex COVID-19 Antigen Home Test Over-the-counter rapid antigen test for at-home self-testing of SARS-CoV-2, FDA EUA authorized for consumer use without a prescription.
• ACON SARS-CoV-2 IgG/IgM Rapid Test Lateral flow immunoassay for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human whole blood, serum, or plasma.
• ACON HIV Rapid Test Lateral flow rapid test for the qualitative detection of antibodies to HIV-1 and HIV-2 in human whole blood, serum, or plasma, intended for professional point-of-care screening.
• ACON hCG Pregnancy Rapid Test Lateral flow rapid test for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum, intended for early pregnancy detection.
• ACON LH Ovulation Rapid Test Lateral flow rapid test for the qualitative detection of luteinizing hormone (LH) in urine to predict ovulation timing.
• ACON Troponin I Rapid Test Lateral flow rapid test for the qualitative detection of cardiac Troponin I in whole blood, serum, or plasma as an aid in the diagnosis of myocardial infarction.
• ACON Fecal Occult Blood Rapid Test Lateral flow rapid test for the qualitative detection of human hemoglobin in fecal specimens as a screening aid for gastrointestinal bleeding.
• Flowflex Monkeypox Virus Rapid Test Lateral flow rapid tests for the qualitative detection of Monkeypox virus antigen and IgG/IgM antibodies, available in multiple variants for point-of-care use.
• FIAflex Fluorescent Immunoassay Analyzer Benchtop fluorescent immunoassay analyzer that quantitatively reads FIA test cartridges for infectious disease, allergy, and other analyte panels.
• FIAflex SARS-CoV-2 Antigen FIA FIA cartridge for the quantitative detection of SARS-CoV-2 nucleocapsid antigen on the FIAflex analyzer, intended for professional use.
• FIAflex SARS-CoV-2 Neutralizing Antibody FIA FIA cartridge for the quantitative detection of SARS-CoV-2 neutralizing antibodies on the FIAflex analyzer.
• FIAflex Influenza A/B FIA FIA cartridge for the qualitative detection and differentiation of Influenza A and Influenza B antigens on the FIAflex analyzer.
• FIAflex Dengue FIA Tests FIA cartridges (NS1 Ag and IgG/IgM) for the detection of dengue virus infection markers on the FIAflex analyzer.
• FIAflex Allergen Specific IgE FIA Tests FIA cartridges for quantitative detection of allergen-specific IgE antibodies, including food nuts, indoor allergen, animal dander, and weed pollens panels.
• Foresight Allergen Specific IgE Antibody Detection Kit Detection kit for allergen-specific IgE antibodies intended for use with the Foresight platform.
• Promotor 960 Real-Time PCR System Benchtop 96-well real-time PCR system for nucleic acid amplification and detection in clinical molecular diagnostic workflows.
• Promotor NES-32 Nucleic Acid Extraction System Automated nucleic acid extraction instrument for sample preparation upstream of PCR testing.
• Promotor SARS-CoV-2 RT-PCR Test Kit Real-time RT-PCR test kit for the qualitative detection of SARS-CoV-2 nucleic acid, available in original and 2G (second-generation) formulations.
• Promotor Hepatitis Virus Quantitative PCR Test Kits Real-time PCR kits for the quantitative detection of hepatitis virus (HBV/HCV) nucleic acid.
• Promotor HIV 1/2 Quantitative PCR Test Kit Real-time PCR kit for the quantitative detection of HIV-1 and HIV-2 viral RNA.
• Promotor HPV Series PCR Test Kits Real-time PCR kits for the detection and genotyping of human papillomavirus (HPV) nucleic acid.
• Promotor TB PCR Test Kit Real-time PCR kit for the detection of Mycobacterium tuberculosis complex nucleic acid.
• Promotor Monkeypox Virus Real-Time PCR Test Kit Real-time PCR kit for the qualitative detection of Monkeypox virus nucleic acid.
• Promotor HLA-B27 PCR Test Kit Real-time PCR kit for the detection of HLA-B27 alleles associated with ankylosing spondylitis and related conditions.
• Promotor Viral Nucleic Acid Isolation Kits Reagent kits for the extraction and purification of viral nucleic acid from clinical specimens.
• Promotor Sample Collection Kit Specimen collection and transport kit intended for use with Promotor PCR workflows.
• Mission HemoPro Hemoglobin Testing System Point-of-care hemoglobin meter for quantitative measurement of hemoglobin in capillary or venous whole blood.
• Mission Plus Hb Hemoglobin Testing System Point-of-care hemoglobin meter with enhanced features for quantitative hemoglobin measurement.
• Mission Ultra Hb Hemoglobin Testing System Point-of-care hemoglobin meter variant designed for low-resource and field settings.
• Mission Cholesterol Monitoring System Point-of-care meter for quantitative measurement of total cholesterol in capillary blood.
• Mission Ultra Cholesterol Monitoring System Enhanced point-of-care meter variant for cholesterol monitoring.
• Mission PT/INR Monitoring System Point-of-care meter for prothrombin time (PT) and international normalized ratio (INR) measurement for oral anticoagulant monitoring.
• Mission C-100 Dry Chemistry Analyzer Dry chemistry analyzer for quantitative measurement of clinical chemistry analytes at the point of care.
• Mission HA-360 3-Diff Automatic Hematology Analyzer Automated 3-part differential hematology analyzer for CBC testing in clinical settings.
• Quik-Check HA-360 3-Diff Automatic Hematology Analyzer 3-part differential hematology analyzer offered under the Quik-Check brand for clinical CBC testing.
• Mission U60 Urine Analyzer Semi-automated urine chemistry analyzer for routine urinalysis in clinical settings.
• Mission U500 Urine Analyzer Automated urine chemistry analyzer for high-volume urinalysis workflows.
• Mission U120 Smart Urine Analyzer Smart urine chemistry analyzer with connectivity features for clinical urinalysis.
• Mission Urinalysis Reagent Strips Reagent strips for urine chemistry analysis, available in standard and Mission Expert formulation variants, used with Mission urine analyzers.
• Mission Urine Control Quality control materials for routine verification of Mission urinalysis reagent strip performance.

Quantifiable outcome

• Flowflex SARS-CoV-2 Antigen Rapid Test achieves 97.1% sensitivity for nasal swabs and 97.6% for nasopharyngeal specimens with 99.5% specificity
• +2 more outcomes

Named customers2 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

Feature6 records

Partnerships

Five partnerships are on record, tiered minor and core.

• Statens Serum Institut (SSI) DenmarkminorStrategic or Co-development Partner · 29 July 2022SSI published clinical study results showing Flowflex SARS-CoV-2 Antigen Rapid Test performed well in detecting Omicron BA.4 and BA.5 variants comparable to wild-type.
• World Health Organization (WHO)coreStrategic or Co-development Partner · 7 April 2022WHO approved and listed ACON Flowflex SARS-CoV-2 Antigen Rapid Test for detecting COVID-19 under WHO's Emergency Use Listing (EUL) procedure. ACON became the first and only manufacturer in China and fifth globally to be on WHO's EUL list for rapid antigen detection tests.
• FIND (Foundation for Innovative New Diagnostics)coreStrategic or Co-development Partner · 24 February 2022ACON participates in FIND's RFP project launched in response to WHO's appeal to accelerate availability of affordable SARS-CoV-2 self-tests in low- and middle-income countries (LMICs).
• TÜV SÜDcoreImplementation/ SI/ Consulting Partner · 14 May 2021TÜV SÜD (CE0123) issued CE certificate for Flowflex SARS-CoV-2 Antigen Rapid Test for self-testing, validated from May 14, 2021 until May 26, 2024.
• NHS UK (National Health Service)coreChannel Partner/ Reseller/ DistributorFlowflex COVID-19 Antigen Rapid Tests widely distributed through NHS for national testing programs in the UK.

Scale indicators4 records

Direct peers

• QuidelOrtho: QuidelOrtho (formed from the Quidel-Ortho merger) markets the Sofia rapid antigen platform and a broad immunoassay and donor-screening portfolio. Its Sofia SARS Antigen FIA is a near-direct substitute for ACON's Flowflex, with overlapping FDA EUA, hospital, and retail channels.
• Becton, Dickinson and Company (BD): BD offers the BD Veritor rapid antigen and immunoassay systems, plus microbiology and molecular diagnostics. BD Veritor competes head-to-head with ACON's Mission POCT and rapid test products in US hospitals and physician offices.
• Access Bio: Access Bio manufactures CareStart rapid diagnostic tests for infectious diseases including COVID-19, malaria, and HIV. It is comparable to ACON as a lateral-flow-focused manufacturer selling into global public-health and OTC channels.
• Guangzhou Wondfo Biotech: Wondfo is a leading Chinese IVD manufacturer producing rapid antigen, fertility, infectious disease, and POCT products. It competes directly with ACON in domestic Chinese supply and in OEM/export channels for rapid diagnostics.
• Hangzhou AllTest Biotech: AllTest is a Hangzhou-based Chinese peer that produces lateral flow rapid tests for infectious disease, fertility, and drugs of abuse, directly overlapping with ACON's immunoassay and rapid test portfolio.
• SD Biosensor: SD Biosensor is a Korean IVD manufacturer with Standard Q COVID Ag, Standard F FIA, and molecular diagnostics lines. It is one of the closest direct competitors to ACON in rapid antigen, FIA, and global public-health tenders.
• OraSure Technologies: OraSure develops rapid diagnostic tests including OraQuick HIV, HCV, and COVID-19 antigen tests for professional and consumer use. It is a US-based peer with overlapping lateral flow, infectious disease, and self-testing positioning to ACON's Flowflex and Mission lines.

Broad incumbents

• Siemens Healthineers: Siemens Healthineers offers the CLINITEST rapid COVID-19 antigen test, the epoc POCT blood gas system, and a broad immunoassay and molecular diagnostics portfolio. It competes with ACON's POCT and FIA lines inside European and emerging-market hospital accounts.
• Roche Diagnostics: Roche operates a global diagnostics franchise across immunoassay, molecular PCR, point-of-care, and self-testing. It competes with ACON across multiple platforms but at significantly greater scale and brand strength, particularly in European hospital tenders.
• Abbott Diagnostics: Abbott's diagnostics division offers the BinaxNOW COVID-19 Antigen Self Test and Panbio rapid antigen tests, alongside a broad POCT, immunoassay, and molecular diagnostics portfolio. It is the most direct large-scale comparator to ACON's Flowflex and POCT lines.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/acon-biotech

Compliance15 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries2 records

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 ACON Biotech