AB ANALITICA
AB ANALITICA is an Italian IVD company developing molecular diagnostic kits, NGS solutions, breath tests, fertility products, and biobanking systems for clinical laboratories and hospitals. Since January 2026, it operates as part of Gold Standard Diagnostics.
- Company typePrivate
- Founded1994
- HeadquartersPadova, Italy
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What AB ANALITICA does
AB ANALITICA S.r.l. is a Padova-based Italian in vitro diagnostics (IVD) company founded in the early 1990s, specializing in molecular diagnostics, breath testing, fertility, and biobanking solutions for professional clinical and hospital laboratories. The company develops, manufactures, and commercializes CE-IVD certified Real-Time PCR kits (REALQUALITY line for infectious diseases, antibiotic resistance screening, and mycology; AMPLIQUALITY for HPV and reverse line blot applications), Next Generation Sequencing kits (GENEQUALITY WES for whole exome sequencing and GENEQUALITY CFTR), the integrated GENEQUALITY 2050 sample-to-result platform, point-of-care molecular systems (EasyNAT, MultNAT), 13C and H2 breath test products (including the patented BREATHQUALITY UBT registered as a medicinal product), and biobanking hardware and software. It also operates the certified LACAB clinical analysis laboratory, providing outsourced breath test sample analysis with a 3-day turnaround. The company is ISO 9001:2015, ISO 13485:2021, and IVDR (EU 2017/746) certified through TÜV SÜD Notified Body 0123.
The business model combines direct sales of proprietary diagnostic products, instruments, and reagents through an Italian regional sales agent network and Product Specialists, with exclusive distribution agreements for third-party products (SNIBE immunoassays, ABL Diagnostics NGS, USTAR POCT) and partner-distributed quality control materials (ThermoFisher AcroMetrix, Microbix, Zeptometrix, Microbiologics, Qnostics) and EQA programs (QCMD, One World Accuracy, UK NEQAS). Revenue is generated through one-time product sales, instrument placements, clinical analysis services, and ISO-certified technical support and maintenance contracts. Customer segments include clinical and hospital diagnostic laboratories (primary), research institutions, fertility/PMA clinics, and biobanking facilities, with the primary market in Italy and selective international presence through trade events. In January 2026, AB ANALITICA became a subsidiary of Gold Standard Diagnostics, a multi-vertical diagnostic network, expanding its access to immunoassay and adjacent diagnostic modalities.
AB ANALITICA firmographics
Firmographics- Name
- AB ANALITICA
- Legal name
- AB ANALITICA S.r.l.
- Website
- https://abanalitica.com
- Company type
- Private
- Founded year
- 1994
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- AB ANALITICA is an Italian IVD company developing molecular diagnostic kits, NGS solutions, breath tests, fertility products, and biobanking systems for clinical laboratories and hospitals. Since January 2026, it operates as part of Gold Standard Diagnostics.
- Ownership category
- akta.pro rank
AB ANALITICA industry classification
Industry- Product category
- In Vitro Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Equipment and Supplies Manufacturing (3391)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)
- akta.pro secondary industries
- Laboratory Automation, Sample Prep & Liquid Handling (IVD Lab Diagnostics) (HLAHAAAN), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Sample Logistics, Biorepository & IVD Kit Management (Trial Support) (HLAGAEAI)
Keywords
Where AB ANALITICA is headquartered
LocationHeadquarters
- HQ city
- Padova
- HQ country
- Italy
- HQ region
- Europe
Offices3 records
Markets served
AB ANALITICA 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
- Diagnostic Products Sales: Design, development, production and commercialization of in vitro diagnostic medical devices including molecular diagnostic kits (Real-Time PCR, NGS), breath tests, fertility products, and biobanking solutions. Products are sold directly to clinical laboratories and through distributor partnerships.
- Clinical Analysis Services: Analysis of exhaled breath samples (Breath Test) at the certified LACAB laboratory with guaranteed report release within 3 working days. Also offers urine sample analysis for intestinal permeability evaluation.
- Instrument Sales and Distribution: Commercialization of instrumentation, reagents and accessories for molecular and cellular biology, including automated systems, Real-Time PCR systems, and end-point PCR systems.
- Quality Control Products Distribution: Distribution of quality control materials (AcroMetrix/ThermoFisher, Microbix, Zeptometrix, Microbiologics, Qnostics) and VEQ programs (QCMD, One world Accuracy, UK Neqas).
- Technical Support Services: ISO 9001 and ISO 13485 certified technical assistance service providing ordinary and extraordinary 'Full Risk' maintenance including spare parts, consumables, software updates, and hardware parts.
Go-to-market motion1 record
Distribution channels6 records
Marketing channels8 records
AB ANALITICA product offering
Product offeringCore offering
AB ANALITICA designs, develops, manufactures, and commercializes in vitro diagnostic (IVD) medical devices for professional use, including molecular diagnostic kits (Real-Time PCR, Next Generation Sequencing), point-of-care testing systems, automated instrumentation, breath test products for H. pylori diagnosis, fertility and assisted reproduction testing solutions, and biobanking products. The company also operates a certified clinical analysis laboratory (LACAB) providing breath test analysis services, and distributes third-party quality control materials and external quality assessment programs.
Product overview
AB ANALITICA develops and commercializes a comprehensive portfolio of in vitro diagnostic solutions for professional use, organized into distinct product lines: Molecular Diagnostics (Real-Time PCR kits, POCT systems including EasyNAT® and MultNAT®, Next Generation Sequencing products such as GENEQUALITY® WES and CFTR, Reverse Line Blot, and automated instruments including the GENEQUALITY® 2050 sample-to-result platform); Breath Testing (AB 13C and H2 breath test products with dedicated instrumentation); Fertility and PMA (testing solutions and media); Biobanking (sample management hardware, software, and consumables); Quality Control (internal and external programs); and Rapid Tests. The portfolio is complemented by the BREATHQUALITY Webservice for outsourced clinical analysis. The company entered Gold Standard Diagnostics group in January 2026, expanding its immunoassay offerings.
Differentiator
Problem solved
Functional benefit
Brands
- GENEQUALITY: Product line for molecular diagnostics including Real Time PCR, NGS kits (WES, CFTR), and automated instruments for sample-to-result testing.
- REALQUALITY
- AMPLIQUALITY
- BREATHQUALITY
- LACAB
Products and services
- GENEQUALITY 2050 Sample-to-Result Platform Fully integrated automated sample-to-result Real-Time PCR system with onboard DNA/RNA extraction, PCR preparation, and result analysis, processing up to 32 samples simultaneously with bidirectional LIS interfacing. Used by clinical diagnostic laboratories.
- GENEQUALITY Whole Exome Sequencing Kit CE-IVD NGS kit for enriched whole exome and mitochondrial genome library preparation, sequencing approximately 42Mb (19,441 genes) and detecting CNVs, InDels, SNPs, and SNVs. Used by clinical and research laboratories.
- GENEQUALITY CFTR Kit CE-IVD amplification-based library preparation kit for comprehensive CFTR gene analysis via NGS, detecting mutations, indels, and CNVs in exonic, intron-exon boundaries, promoter regions, and clinically relevant intronic variants. For clinical diagnostic laboratories.
- Real Time PCR Diagnostic Kits Comprehensive line of Real-Time PCR diagnostic kits covering infectious diseases (respiratory, gastrointestinal, fungal infections), transplant monitoring, antibiotic resistance, HPV/STI, antiviral therapy monitoring, coagulation, hemochromatosis, and onco-hematology. Used by clinical diagnostic laboratories.
- POCT (Point-of-Care Testing) Products - EasyNAT and MultNAT Point-of-Care molecular diagnostic products for rapid nucleic acid testing at decentralized settings, distributed through a strategic partnership with USTAR Biotechnology.
- Reverse Line Blot Products Products including GENEQUALITY AB-THROMBO TYPE PLUS, AZF Y-TYPE, CD-TYPE v2.0, AMPLIQUALITY HCV TYPE PLUS v2.0, and HPV-TYPE EXPRESS v3.0 for multiplex genetic analysis. Used by clinical and research laboratories.
- REALQUALITY Candida Plus
- REALQUALITY Carba-Screen
- REALQUALITY Aspergillus
- AB 13C Breath Test Products (BREATHQUALITY UBT) 13C urea breath test products including BREATHQUALITY UBT, a patented liquid formulation registered as a medicinal product (AIC n° 034510014) for H. pylori diagnosis. Used by clinical laboratories and gastroenterology clinics.
- AB H2 Breath Test Products Hydrogen breath test products for lactose intolerance and small intestinal bacterial overgrowth (SIBO) diagnosis. Used by clinical laboratories and gastroenterology clinics.
- Breath Test Instrumentation Breath analysis instruments including ABCA2 ANALYSER, HeliFAN/HeliFANplus, FANhp, and LactoFAN2 for 13C and H2 breath testing. Used by clinical laboratories performing breath diagnostics.
- Fertility and PMA Products Complete fertility testing solutions including classic tests, biochemical tests, immunological tests, automated instruments, semen DNA analysis devices, culture media, and vitrification media for assisted reproduction. Used by fertility centers and PMA clinics.
- Biobanking Products Biobanking management products including laser-barcoded 2D tubes, barcode scanning systems (AB SCAN), BIOBANKER software, sample storage tubes, tissue containers, and label printers. Used by biobanking facilities and research institutions.
- Quality Control Products (CQI & VEQ) Internal quality controls and external quality assessment programs including AcroMetrix, Microbix, Zeptometrix, Microbiologics, Qnostics products, and QCMD/One World Accuracy/UK NEQAS programs. Used by clinical and research laboratories.
- Technical Support and Maintenance Services ISO 9001 and ISO 13485 certified technical assistance service providing ordinary and extraordinary 'Full Risk' maintenance including spare parts, consumables, software updates, and hardware parts. Provided to clinical and hospital diagnostic laboratories.
- BREATHQUALITY Webservice (Clinical Analysis Service) Clinical analysis service for breath test samples with complete logistics, laboratory analysis at the LACAB certified lab, and result reporting within 3 working days. Includes BREATHQUALITY Webservice for tracking sample analysis status. Provided to healthcare providers.
- Immunoassays (ELISA, CLIA, Automation) Immunoassay products including ELISA, CLIA, and automation solutions distributed through the Gold Standard Diagnostics partnership and SNIBE distribution agreement. Used by clinical diagnostic laboratories.
Companies that use AB ANALITICA
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles4 records
AB ANALITICA technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature8 records
AB ANALITICA partnerships and signals
Strategic signalPartnerships
17 partnerships are on record, tiered core and minor.
- Gold Standard Diagnostics (GSD)coreIn January 2026, AB ANALITICA joined Gold Standard Diagnostics, a leading network of companies providing diagnostic solutions for clinical, industrial, and animal health sectors. GSD has extensive experience in the clinical market including production and commercialization of automated platforms and a broad test menu in virology, bacteriology, parasitology, mycology, hormones, autoimmune diseases, and oncology. AB ANALITICA's scientific expertise and innovation track record align perfectly with GSD's long-term vision.
- USTAR BiotechnologycoreStrategic partnership announced in June 2025 for the distribution of molecular point-of-care diagnostics in Italy. AB ANALITICA serves as the strategic partner for USTAR's point-of-care molecular diagnostic products in the Italian market.
- EnaleesminorPartnership announced in September 2024 for animal wellness diagnostics, with the launch of GENEQUALITY Whole Exome Sequencing Kit. Collaboration focused on genetic diagnostics solutions for veterinary applications.
- SNIBEcoreDistribution partnership announced in July 2024 for SNIBE immunoassay products in Italy. AB ANALITICA serves as the exclusive distributor for SNIBE's diagnostic products in the Italian market, expanding the company's portfolio to include CLIA and other immunoassay technologies.
- ABL DiagnosticsminorExclusive distribution agreement announced in February 2024 for ABL Diagnostics' microbiological genotyping solutions in NGS in Italy. ABL Diagnostics SA and AB ANALITICA combined forces to offer advanced NGS-based microbiological genotyping solutions to the Italian market.
- ThermoFisher Scientific (AcroMetrix)minorQuality control materials distribution partner. AB ANALITICA distributes ThermoFisher Scientific's AcroMetrix quality control products for molecular biology and serology testing.
- MicrobixminorQuality control materials distribution partner for molecular biology quality control products.
- ZeptometrixminorQuality control materials distribution partner for molecular biology quality control products.
- MicrobiologicsminorQuality control materials distribution partner for molecular biology quality control products.
- QnosticsminorQuality control materials distribution partner and VEQ program provider for molecular diagnostics quality control.
- QCMDminorExternal Quality Assessment (EQA) / VEQ program provider for molecular diagnostics laboratories.
- One World AccuracyminorVEQ program provider for quality assessment in molecular diagnostics.
- UK NEQASminorVEQ program provider for external quality assessment in molecular diagnostics.
- All TestsminorRapid test products partner providing point-of-care testing solutions.
- Mascia BrunelliminorRapid test products partner providing diagnostic solutions.
- LTAminorRapid test products partner providing diagnostic solutions.
- European Commission (Horizon Programs)minorCollaborative research partner in multiple EU-funded Horizon projects including HERCULES (H2020), DECIDER (H2020-SC1), DNA-FAIRYLIGHTS (H2020-FETOPEN), and PROSEQO (H2020-FETOPEN). Projects focus on ovarian cancer diagnostics, single-cell analysis, and protein sequencing technologies.
Scale indicators4 records
Recent moves6 records
Expansion highlights6 records
AB ANALITICA competitors and assessment
Company assessmentBroad incumbents
- Hologic: US-based diagnostics and women's health company with Panther molecular testing systems and HPV/ STI assays. Comparable broad incumbent whose molecular menu (HPV, sexually transmitted infections, infectious disease) overlaps with REALQUALITY/AMPLIQUALITY product lines.
- Cepheid: Subsidiary of Danaher operating the GeneXpert integrated cartridge-based PCR platform. Comparable broad incumbent competing in sample-to-result molecular testing — the same category targeted by AB ANALITICA's GENEQUALITY 2050 platform.
- bioMérieux: Global IVD and microbiology specialist spanning clinical, industrial, and animal health diagnostics. Comparable as a broad incumbent covering infectious-disease PCR, antibiotic-resistance screening (Carba-Screen overlap), and automated microbiology in the same end-markets.
- QIAGEN: Global leader in sample-preparation technologies, PCR kits, NGS, and IVD automation. Comparable as a broad incumbent whose Real-Time PCR, NGS library prep, and automation platforms directly overlap with AB ANALITICA's GENEQUALITY and REALQUALITY menus.
- QuidelOrtho: Global IVD player with molecular, immunoassay, and rapid-test franchises post-Quidel/Ortho merger. Comparable broad incumbent offering a multi-technology menu that intersects with AB ANALITICA's molecular, immunoassay (via SNIBE), and rapid-test lines.
Direct peers
- ELITechGroup: European mid-sized IVD manufacturer offering molecular biology kits, clinical chemistry, and microbiology products through regional distributors. Comparable in size, mid-market positioning, and direct sales model in Italy and southern Europe.
- Seegene: Korean molecular diagnostics company specializing in multiplex Real-Time PCR and Syndromic testing kits. Comparable specialized molecular diagnostics peer selling through OEM/distributor channels in Europe, with overlapping menu in respiratory, STI, and gastroenterology panels.
- DiaSorin: Italy-headquartered IVD company with parallel molecular diagnostics, immunoassay, and specialty-testing franchises. Directly comparable as another Italian-rooted diagnostics firm combining proprietary kits, instruments, and distribution across clinical and hospital labs.
Emerging players
- SpeeDx: Australia-based molecular diagnostics company developing PCR-based infectious disease and antimicrobial resistance assays. Comparable emerging player with a menu (respiratory, STI, antibiotic resistance) directly mirroring REALQUALITY and POCT positioning.
- Genetic Signatures: Australian molecular diagnostics developer of 3base multiplex PCR kits targeting infectious disease and hospital labs. Comparable emerging player with a similar menu focus and distributor-led European go-to-market for molecular kit customers.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
AB ANALITICA social profiles
Digital presenceAB ANALITICA compliance and trust
Trust signalCompliance3 records
AB ANALITICA financial estimates
Financial estimateRevenue estimate
Valuation estimate
AB ANALITICA leadership team
Management profileNumber of profiles
Profiles1 record
AB ANALITICA funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
AB ANALITICA 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 AB ANALITICA
What does AB ANALITICA do?
AB ANALITICA designs, develops, manufactures, and commercializes in vitro diagnostic (IVD) medical devices for professional use, including molecular diagnostic kits (Real-Time PCR, Next Generation Sequencing), point-of-care testing systems, automated instrumentation, breath test products for H. pylori diagnosis, fertility and assisted reproduction testing solutions, and biobanking products. The company also operates a certified clinical analysis laboratory (LACAB) providing breath test analysis services, and distributes third-party quality control materials and external quality assessment programs.
Is AB ANALITICA a public or private company?
AB ANALITICA is a private company. It is classified as corporate owned and is currently operating.
When was AB ANALITICA founded?
AB ANALITICA was founded in 1994. It employs 51 to 100 people.
Where is AB ANALITICA based?
AB ANALITICA is headquartered in Padova, Italy, in the Europe region.
How does AB ANALITICA make money?
Five revenue lines are on record. Diagnostic Products Sales are the primary driver. The others are clinical Analysis Services, instrument Sales and Distribution, quality Control Products Distribution and technical Support Services.
Who are AB ANALITICA's main competitors?
Broad incumbents on record are Hologic, Cepheid, bioMérieux, QIAGEN and QuidelOrtho. Direct peers are ELITechGroup, Seegene and DiaSorin. Emerging players are SpeeDx and Genetic Signatures.
Does AB ANALITICA have an API?
No public API is recorded for AB ANALITICA.
What industry is AB ANALITICA in?
AB ANALITICA's product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument), with a secondary code of HLAHAAAN, Laboratory Automation, Sample Prep & Liquid Handling (IVD Lab Diagnostics). Its NAICS code is 325413 and its SIC code is 2835.