What Biosynex does

Biosynex SA is a French in-vitro diagnostics company founded in 2005 in Illkirch-Graffenstaden and listed on Euronext Paris (EPA:ALBIO). It designs, manufactures, and distributes rapid diagnostic tests (TDR/TROD), point-of-care instruments, and molecular biology platforms (Ampliflash, Ampliquick, Vita PCR), alongside consumer-facing self-tests under the EXACTO brand (HIV, urinary and vaginal infections, pregnancy, ovulation, COVID-19, cannabis, gluten, tetanus). Professional products are sold directly to medical laboratories, hospitals, and clinics, while consumer self-tests, Parakito anti-mosquito products, and eye care items (INNOXA) are distributed through the French pharmacy network and mass retail. The company derives revenue primarily from one-time sales of tests and instruments, with a consumable subscription model for recurring professional orders and instrument-placed reagent flows for point-of-care systems; pricing includes a €1,000 minimum order for export, 30-day terms for private labs, and 50-day terms for French public hospitals. Internationally, Biosynex operates in 90+ countries through distributors and, following the May 2022 acquisition of BHR, through a direct sales force in the United Kingdom.

Name

Biosynex

Legal name

BIOSYNEX SA

Website

https://biosynex.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

101–250 employees

Short description

Biosynex is a French publicly-listed in-vitro diagnostics company that designs, manufactures, and distributes rapid diagnostic tests, point-of-care instruments, molecular biology platforms, and consumer self-tests to laboratories, hospitals, pharmacies, and mass retail across 90+ countries.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

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

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

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

Keywords

• Rapid diagnostic tests
• In vitro diagnostics
• Point of care testing
• Molecular biology diagnostics
• Self-diagnostic tests

Headquarters

HQ city

Illkirch-graffenstaden

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Rapid Diagnostic Tests (Professional): Sale of professional rapid diagnostic tests to laboratories, hospitals, pharmacies, and medical facilities for clinical use
2. Self-Diagnostic Tests (Consumer): Sale of self-tests directly to consumers through pharmacies and mass retail channels including pregnancy tests, HIV tests, infection tests, COVID tests
3. Point of Care Systems: Sale and installation of diagnostic systems including instruments, reagents, and consumables with 12-month warranty and maintenance contracts
4. Prevention Products: Parakito anti-mosquito products including bracelets, sprays, and after-bite treatments sold through pharmacy and retail channels
5. Molecular Biology Products: Distribution and sale of molecular biology solutions including Ampliflash, Ampliquick, and Vita PCR systems
6. Subscription/Bundled Orders: Subscription model with scheduled deliveries for consumables with minimum 12-month periods and defined delivery periodicity

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels5 records

Core offering

Biosynex designs, manufactures, and distributes rapid diagnostic tests (RDT/TROD) and self-tests on membrane support. Its professional portfolio includes point-of-care systems (Procise DX, Pathfast, BSX Reader, Skyla HB1) and molecular biology platforms (Ampliflash, Ampliquick, Vita PCR) for laboratories and clinicians, while its consumer line covers self-tests (HIV EXACTO, urinary, vaginal, pregnancy, ovulation, COVID-19, cannabis, gluten, tetanus) and Parakito anti-mosquito prevention products sold through pharmacies and mass retail.

Product overview

Biosynex is a French medtech company specializing in the design, manufacture, and distribution of in vitro diagnostic products. The company operates a multi-segment portfolio structured around rapid diagnostic tests (RDT) and self-tests for both professional healthcare settings and consumers. Professional products include point-of-care devices (Procise DX, Pathfast, BSX Reader, Skyla HB1) and molecular biology solutions (Ampliflash, Ampliquick, Vita PCR). Consumer self-tests cover HIV (EXACTO), urinary infections, vaginal infections, pregnancy, ovulation, COVID-19, cannabis, gluten, and tetanus. The company also offers Parakito anti-mosquito products and prevention/natural care items. Following acquisitions of ProciseDx, Chembio Diagnostics, Avalun, and Parakito, Biosynex has expanded into therapeutic drug monitoring and the US market.

Differentiator

Problem solved

Functional benefit

Brands

• Parakito: Anti-mosquito products including bracelets, sprays, and after-bite treatments with essential oil formulations
• Exacto
• Ampliflash
• Ampliquick
• Vita PCR
• Procise DX
• Skyla HB1
• Pathfast
• BSX Reader
• Bodyflash

Products and services

• Rapid Diagnostic Tests (TDR/TROD) Professional-grade rapid diagnostic tests on membrane support covering infectious diseases and other conditions, designed for use by clinicians, laboratories, and pharmacies.
• Self-Tests (Autotests) Consumer-facing diagnostic self-tests for home use including HIV (EXACTO), urinary infections, vaginal infections, pregnancy, ovulation, cannabis, gluten, tetanus, and COVID-19 antigen tests.
• Procise DX Point-of-care diagnostic system for rapid therapeutic drug monitoring (infliximab and adalimumab) with results in five minutes; FDA De Novo authorized.
• Pathfast Point-of-care diagnostic platform for rapid biomarker testing at the point of patient care, used in laboratories and clinical settings.
• BSX Reader Rapid diagnostic test reader for point-of-care testing applications, providing automated reading of Biosynex rapid tests.
• Skyla HB1 Point-of-care clinical chemistry analyzer for use in clinical laboratory and point-of-care testing settings.
• Ampliflash Molecular biology system for nucleic acid amplification testing used in laboratories and by biologists.
• Ampliquick Molecular biology diagnostic solution enabling rapid nucleic acid testing for laboratory and clinical use.
• Vita PCR Point-of-care molecular PCR system distributed by Biosynex (via Credo Diagnostics partnership) for rapid DNA/RNA detection, deployed in the UK and other territories.
• EXACTO HIV Self-Test Rapid HIV self-test for consumer use detecting HIV-1 and HIV-2 antibodies with 99.9% reliability after the 3-month seroconversion window.
• EXACTO Urinary Infection Self-Test Self-test strip detecting four urinary parameters (leukocytes, nitrites, blood, proteins) for urinary tract infection screening, delivering results in 1-2 minutes with 93.1%-97.3% reliability.
• Vaginal Infections Self-Test Self-test measuring vaginal pH to differentiate bacterial vaginosis, Trichomonas infection, and mycosis with 100% sensitivity and 96.8% specificity.
• Streptatest (Angine Test) Rapid strep A test for professional use in pharmacies and clinics, supported by Biosynex e-learning training for healthcare professionals.
• COVID-19 Antigen Self-Test (Ag) Rapid antigen self-test for COVID-19 detection sold via pharmacy network and mass retail.
• Pregnancy and Ovulation Self-Tests Home pregnancy tests (including 8-day early detection and Simply variants) and ovulation self-tests for family planning.
• Parakito Anti-Mosquito Products Anti-mosquito bracelets, sprays, and after-bite treatments using patented essential oil diffusion technology, sold via pharmacy and retail channels for mosquito-borne disease prevention.
• Prevention Equipment (Thermometers, Tensiometers, Oximeters) Home and professional prevention devices including thermometers, blood pressure monitors (tensiometers), and oximeters distributed through pharmacies.
• Natural Care Products (Thermotherapy, Inhalation Chambers) Natural care products including thermotherapy devices and inhalation chambers sold via the pharmacy division.

Quantifiable outcome

• 99.9% reliability for HIV self-test when used 3 months after risk exposure
• +2 more outcomes

Named customers4 records

Segments1 record

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

Seven partnerships are on record, tiered core and minor.

• THERADIAGcoreOthers · 1 September 2023Proposed merger by absorption of THERADIAG by BIOSYNEX. THERADIAG specializes in the design, distribution, and commercialization of in vitro diagnostic devices, complementing Biosynex's diagnostic portfolio.
• ProciseDx Inc.coreOthers · 1 June 2023Acquisition of ProciseDx to commercialize FDA-approved rapid point-of-care drug monitoring tests for infliximab and adalimumab in the US market. ProciseDx technology offers results within five minutes, addressing current delays and expenses in therapeutic drug monitoring.
• INNOXA LaboratoriesminorOthers · 1 June 2023Acquisition of INNOXA Laboratories' eye care activity, adding a range of eye care and prevention products to strengthen the Biosynex Pharmacy Division (Biosynex Pharma).
• Chembio Diagnostics Inc.coreOthers · 1 May 2023Successful tender offer (OPA) for Chembio Diagnostics Inc., marking a major milestone in Biosynex's history. The acquisition provides direct access to the US market, the largest IVD market by revenue. Chembio already holds numerous FDA approvals including 510(k), PMA, and CLIA-waived products.
• Credo Diagnostics Biomedical Pte LtdcoreChannel Partner/ Reseller/ Distributor · 1 May 2022Extended distribution agreement with Credo Diagnostics for VitaPCRTM molecular diagnostics systems. The agreement includes exclusive distribution rights for an expanded territory including the United Kingdom. Biosynex leverages its direct sales force established through BHR acquisition to deploy VitaPCRTM systems in the UK market.
• Evergreen LandminorOthers · 1 April 2022Biosynex acquired all assets, patents, and trademarks of Parakito anti-mosquito products from Evergreen Land for exploitation in Europe, Africa, and South America as part of diversification strategy following COVID-19 related growth.
• AvaluncoreOthers · 1 May 2021Acquisition of Avalun to strengthen Biosynex's position as a European leader in rapid diagnostic testing, expanding product portfolio and market presence.

Scale indicators4 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• Hologic: US women's health and molecular diagnostics leader with the Panther molecular platform and ThinPrep cytology franchise. Comparable to Biosynex's molecular biology systems (Ampliflash, Ampliquick, Vita PCR) and represents the type of scale player Biosynex competes with in lab-based and POC molecular.
• Roche Diagnostics: World's largest IVD franchise, with cobas central lab, cobas Liat POC PCR, and rapid test offerings. Direct overlap with Biosynex's molecular and POC strategies and a primary competitive reference for European hospital and laboratory channels.
• Abbott Diagnostics: Global IVD leader spanning immunoassays, point-of-care (i-STAT), rapid tests (Binax), and molecular diagnostics. Competes with Biosynex across nearly every product category and represents the type of large incumbent that constrains pricing and shelf access for mid-cap rapid-test players.

Direct peers

• SD Biosensor: South Korean rapid diagnostics company with strong global COVID test franchise and a growing POC and clinical chemistry portfolio. Direct competitor in professional RDTs and POC, particularly in emerging markets where Biosynex distributes internationally.
• Meridian Bioscience: US-headquartered diagnostics company offering rapid tests for infectious disease and gastrointestinal applications plus molecular Life Science reagents. Direct peer in rapid infectious disease testing and a comparable size and channel mix in clinical lab and hospital settings.
• bioMérieux: French-headquartered IVD company with a strong portfolio in microbiology, clinical diagnostics, and industrial applications. Most directly comparable European rapid/molecular diagnostics peer to Biosynex, with similar geographic mix and overlapping customer base of clinical laboratories and hospitals.
• Trinity Biotech: Ireland-based specialty diagnostics company focused on clinical chemistry, infectious disease, and hemoglobin testing. Closely comparable in size, European orientation, and rapid infectious-disease test portfolio overlap with Biosynex's professional RDT range.
• OraSure Technologies: US diagnostics company best known for the OraQuick HIV self-test and rapid infectious disease diagnostics. Highly comparable to Biosynex's EXACTO HIV self-test and self-test consumer strategy, and a direct peer in OTC and professional rapid diagnostics.
• QuidelOrtho: US-based specialty diagnostics company focused on rapid immunoassays, including Sofia and QuickVue branded rapid tests, plus a broader clinical chemistry and immunoassay portfolio. Direct competitor in the rapid diagnostic test and POC testing categories where Biosynex competes.

Emerging players

• Bühlmann Laboratories: Swiss specialty IVD company with strength in inflammatory bowel disease and calprotectin testing. Comparable as a European specialty diagnostics player pursuing menu expansion in clinical laboratory channels that overlap with Biosynex's laboratory customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/c/LaboratoireBiosynex
• Facebookfacebook.com/LaboratoireBiosynex
• LinkedInlinkedin.com/company/biosynex-group

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries7 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A7 records

Investments

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

Frequently asked questions about Biosynex