Amplex Diagnostics
- Company typePrivate
- Founded2002
- HeadquartersGießen-wieseck, Germany
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Amplex Diagnostics does
AmplexDiagnostics GmbH is a privately held German specialty diagnostics company founded in 2002 and headquartered in Gars-Bahnhof, Germany, with sales and marketing operations in Buseck. The company develops, manufactures, and distributes CE IVD-certified molecular diagnostic kits under the eazyplex® brand, based on isothermal Loop-Mediated Isothermal Amplification (LAMP) combined with real-time fluorescence detection. Its core technical differentiator is the use of lyophilized, ready-to-use reagents that ship and store at room temperature and enable direct testing from patient samples (swabs, blood cultures, urine, CSF, stool, BAL) without DNA/RNA extraction, delivering results in 15–30 minutes. The portfolio spans over 20 CE IVD test kits covering Gram-negative resistance (SuperBug family), MRSA, sepsis (BloodScreen), meningitis (CSF direct), Candida auris, sexually transmitted infections, C. difficile, VRE, EHEC, Pneumocystis jirovecii, and hypervirulent K. pneumoniae, supported by a four-instrument device range (eazyMini, eazyOne, Genie HT, Genie II Mk2).
Amplex generates revenue primarily from sale of CE IVD diagnostic kits and instruments, supplemented by a contract lyophilization service for third-party LAMP assays and authorized resale of OptiGene's Genie instruments in Germany and Austria. The company operates exclusively through a global network of more than 30 regional distributors spanning over 40 countries across Europe, the Middle East, Asia, Africa, Oceania, and Latin America, with no direct end-customer sales channel. Customer segments include hospital microbiology laboratories, university institutes, outpatient health centers (MVZs), infection control departments, and research institutions; named end-user references include Teramo Hospital in Italy. Marketing is driven by peer-reviewed scientific publications (30+ studies), conference participation at events such as ESCMID Global, downloadable technical documentation, and a bilingual German/English website.
The company is founder/management-owned, led by managing directors Dr. Lars Wassill and Dr. Dirk Ganghofner, with no disclosed venture capital, private equity, or parent company ownership. Its quality management system is certified under DIN EN ISO 13485 and the EU IVDR, and all products carry CE IVD certification. Revenue, headcount, and financial performance are not publicly disclosed. The company's strategic positioning emphasizes workflow simplicity, room-temperature logistics, and time-to-result advantages over classical microbiology (24–48 hours) for clinical infectious disease diagnostics.
Amplex Diagnostics firmographics
Firmographics- Name
- Amplex Diagnostics
- Legal name
- AmplexDiagnostics GmbH
- Website
- https://eazyplex.com
- Company type
- Private
- Founded year
- 2002
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Ownership category
- akta.pro rank
Amplex Diagnostics industry classification
Industry- Product category
- In Vitro Molecular Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC)
- akta.pro secondary industries
- Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges) (HLAHAOAI), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC)
Keywords
Where Amplex Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Gießen-wieseck
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
Amplex Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Supply Chain, Marketing or Sales, Infrastructure
Revenue model
- CE IVD Diagnostic Kits and Reagents: Amplex Diagnostics generates revenue primarily through the sale of CE IVD-certified molecular diagnostic kits based on the eazyplex® LAMP technology platform. Kits are sold as lyophilized, ready-to-use formats for various pathogen targets including MRSA, carbapenem-resistant bacteria, sepsis pathogens, STDs, and more. Revenue is driven by reagent consumption per test across a global laboratory customer base.
- Diagnostic Instruments: Sale of diagnostic instruments (eazyMini, eazyOne, Genie II, Genie II MK2, Genie HT) that run the eazyplex® test system. The company sells hardware platforms as part of the product ecosystem.
- Lyophilization Service for LAMP Assays: Amplex offers lyophilization services for third-party LAMP assays, converting them into ready-to-use, room-temperature-stable formats compatible with the eazyplex® system. This is a service-based revenue stream.
- OptiGene Equipment Resale: Amplex is an official distributor of OptiGene products (Genie II, Genie III instruments) in Germany and Austria, reselling laboratory equipment as an authorized channel partner.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
Amplex Diagnostics product offering
Product offeringCore offering
Amplex Diagnostics develops, manufactures, and distributes CE IVD certified molecular diagnostic kits and instruments under the eazyplex® brand, using isothermal Loop-Mediated Isothermal Amplification (LAMP) combined with real-time fluorescence detection. The lyophilized, ready-to-use reagent kits enable direct testing from patient samples (blood cultures, swabs, CSF, urine, stool) without DNA/RNA extraction, delivering results in 15-30 minutes for pathogen and antibiotic resistance gene detection across gram-negative resistance, MRSA, sepsis, meningitis, STDs, and fungal infections.
Product overview
Amplex Diagnostics offers the eazyplex® System, a comprehensive CE IVD certified molecular diagnostics platform centered on isothermal LAMP amplification with real-time fluorescence detection. The portfolio comprises four instrument models (eazyMini, eazyOne, Genie HT, Genie II Mk2) and over 20 distinct CE IVD test kit product lines covering major infectious disease categories: Gram-negative resistance (SuperBug CRE, complete, expert, Acineto, AmpC, basic kits), MRSA/MRSAplus, BloodScreen (sepsis panels), Candida auris, STDs, C. difficile, EHEC, Pneumocystis jirovecii, PneumoBug expert, VRE, CSF direct, and hv-K. pneumoniae. All reagents are lyophilized and ready-to-use, shipped and stored at room temperature, with no DNA/RNA extraction required. The company also distributes OptiGene's Genie® II and Genie® III instruments, provides LAMP Designer primer design software, and offers a contract lyophilization service for third-party LAMP assays.
Differentiator
Problem solved
Functional benefit
Brands
- eazyplex® SuperBug CRE: Molecular rapid test for detection of carbapenemase-producing bacteria including KPC, NDM, OXA-48, OXA-181, VIM, and ESBL genes
- eazyplex® SuperBug complete
- eazyplex® SuperBug expert
- eazyplex® SuperBug Acineto
- eazyplex® SuperBug AmpC
- eazyplex® SuperBug basic
- eazyplex® MRSA
- eazyplex® BloodScreen
- eazyplex® CSF direct
- eazyplex® C. difficile
- eazyplex® STD
- eazyplex® PneumoBug expert
- eazyplex® VRE
- eazyplex® EHEC
- eazyplex® hv-K. pneumoniae
- eazyplex® Candida auris
- eazyplex® Pneumocystis jirovecii
Products and services
- eazyplex® System A CE IVD certified molecular diagnostics platform combining isothermal LAMP amplification with real-time fluorescence detection. Features lyophilized, ready-to-use reagents shipped and stored at room temperature, with no DNA/RNA extraction required.
- eazyMini A CE IVD instrument with two independent heating blocks, integrated barcode scanner, intuitive software, and HL7 HIS/LIS connectivity, designed for rapid single tests 24/7 with the best price-performance ratio in the eazyplex® device lineup. Made in Germany.
- eazyOne
Quantifiable outcome
- Reduced sepsis diagnostic turnaround time from 24/48 hours (classical microbiology) to 1 hour (using eazyplex® BloodScreen algorithm)
- +4 more outcomes
Companies that use Amplex Diagnostics
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles3 records
Amplex Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration3 records
AI capability2 records
Feature7 records
Amplex Diagnostics partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- Arrow Diagnostics SRL (Italy)coreArrow Diagnostics SRL is Amplex Diagnostics' exclusive distributor for Italy. The partnership was highlighted through a published case study from Teramo Hospital, where the eazyplex® system was established in the clinical pathology lab using Arrow Diagnostics as the equipment provider.
- AxonLab (Switzerland/Austria/Poland/Czech Republic/Slovenia)coreAxonLab serves as a distributor for Amplex products across multiple European markets including Switzerland, Austria, Poland, Czech Republic, and Slovenia.
- bioactiva diagnostica GmbH (Germany/Egypt/Algeria)corebioactiva diagnostica GmbH distributes Amplex products in Germany, Egypt, and Algeria.
- OptiGene Ltd (UK)coreAmplex Diagnostics is an official distributor of OptiGene products (Genie II and Genie III instruments) for Germany and Austria. The Genie® family of instruments, originally developed by OptiGene, forms the hardware platform for Amplex's LAMP-based eazyplex® diagnostic system. The Genie II, Genie III, and associated consumables are distributed by Amplex under this partnership.
- Menarini Diagnósticos S.A. (Spain)coreMenarini Diagnósticos S.A. distributes Amplex products in Spain.
- Advanced Technology Company K.S.C. (Kuwait)minorATC distributes Amplex products in Kuwait.
- EMM Life Science AB (Sweden/Denmark)minorEMM Life Science AB distributes Amplex products in Sweden and Denmark.
Scale indicators4 records
Recent moves9 records
Expansion highlights5 records
Amplex Diagnostics competitors and assessment
Company assessmentBroad incumbents
- QIAGEN: Germany-based sample-prep and molecular diagnostics provider with the QIAstat-Dx syndromic platform and broad infectious disease PCR kits covering many of the same resistance and pathogen targets as eazyplex®.
- Cepheid (Danaher): US-based molecular diagnostics leader behind the GeneXpert system, serving the same hospital microbiology customers with rapid PCR panels for MRSA, sepsis, CT/NG, C. difficile and carbapenem resistance that Amplex targets, but with much broader menu and global installed base.
- Hologic: US diagnostics and molecular company operating the Panther system for CT/NG, Mycoplasma, HSV and other infectious disease targets overlapping with Amplex's STD and meningitis panels.
- bioMérieux: French in vitro diagnostics leader offering the BioFire FilmArray syndromic panels plus classical microbiology ID/AST solutions to the same hospital lab customers as Amplex, with deeper commercialization resources.
- Roche Diagnostics: Global IVD giant with the cobas molecular platform and extensive sepsis, MRSA, and CT/NG menus, addressing many of the same indications Amplex serves through its eazyplex® kits but at much larger scale.
- Abbott Diagnostics: Major molecular diagnostics player with the Alinity m and m2000 platforms, offering infectious disease and resistance panels that compete with Amplex's eazyplex® portfolio in hospital microbiology labs.
Emerging players
- Accelerate Diagnostics: Emerging player in rapid identification and antimicrobial susceptibility testing directly from positive blood cultures, addressing the same sepsis diagnostic use case as Amplex's eazyplex® BloodScreen panels.
Direct peers
- OptiGene: UK-based developer of the Genie® isothermal instruments that form Amplex's core hardware platform; also a strategic technology partner. Both share isothermal amplification roots, and Amplex is OptiGene's official distributor in Germany and Austria.
- Eiken Chemical: Japanese inventor of Loop-Mediated Isothermal Amplification (LAMP), the underlying chemistry Amplex uses. Eiken licenses its GspSSD polymerase to Amplex and competes directly in LAMP-based IVD reagents for infectious disease and resistance gene detection.
- Meridian Bioscience: US-listed specialty molecular diagnostics company focused on infectious disease testing (C. difficile, CT/NG, group B Strep, HSV, RSV) — a comparable mid-sized specialist serving the same hospital lab customer base as Amplex.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Amplex Diagnostics social profiles
Digital presenceAmplex Diagnostics compliance and trust
Trust signalCompliance3 records
Amplex Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Amplex Diagnostics leadership team
Management profileNumber of profiles
Profiles2 records
Amplex Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Amplex Diagnostics 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 Amplex Diagnostics
What does Amplex Diagnostics do?
Amplex Diagnostics develops, manufactures, and distributes CE IVD certified molecular diagnostic kits and instruments under the eazyplex® brand, using isothermal Loop-Mediated Isothermal Amplification (LAMP) combined with real-time fluorescence detection. The lyophilized, ready-to-use reagent kits enable direct testing from patient samples (blood cultures, swabs, CSF, urine, stool) without DNA/RNA extraction, delivering results in 15-30 minutes for pathogen and antibiotic resistance gene detection across gram-negative resistance, MRSA, sepsis, meningitis, STDs, and fungal infections.
Is Amplex Diagnostics a public or private company?
Amplex Diagnostics is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Amplex Diagnostics founded?
Amplex Diagnostics was founded in 2002. It employs 11 to 50 people.
Where is Amplex Diagnostics based?
Amplex Diagnostics is headquartered in Gießen-wieseck, Germany, in the Europe region.
How does Amplex Diagnostics make money?
Four revenue lines are on record. CE IVD Diagnostic Kits and Reagents are the primary driver. The others are diagnostic Instruments, lyophilization Service for LAMP Assays and optiGene Equipment Resale.
Who are Amplex Diagnostics's main competitors?
Broad incumbents on record are QIAGEN, Cepheid (Danaher), Hologic, bioMérieux, Roche Diagnostics and Abbott Diagnostics. Accelerate Diagnostics is listed as an emerging player. Direct peers are OptiGene, Eiken Chemical and Meridian Bioscience.
Does Amplex Diagnostics have an API?
No public API is recorded for Amplex Diagnostics.
What industry is Amplex Diagnostics in?
Amplex Diagnostics's product category is In Vitro Molecular Diagnostics. Its primary akta.pro industry code is HLAAALAC, Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels), with a secondary code of HLAHAOAI, Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges). Its NAICS code is 325413 and its SIC code is 2835.