What Clonit does

Clonit srl is an Italian biotechnology company founded in 1987 and headquartered in Abbiategrasso, Milan, that designs, develops, manufactures, and distributes in vitro diagnostic (IVD) kits and instruments for molecular and genetic biology applications. The company operates a dual revenue model: it manufactures proprietary diagnostic assays (Real-Time PCR, NGS, immunochromatographic assays, ELISA, CLIA, LFA) covering genetic diseases (e.g., Gluten DQuick DResolution v4 for celiac disease HLA typing), infectious diseases (transplantation panel, respiratory, HPV, STDs, tropical, hepatitis, nosocomial), oncology (fastGEN NGS cancer panels via BioVendor), and fungal infections; concurrently, it acts as the exclusive Italian distributor for at least six international IVD manufacturers (ViennaLab Diagnostics, Certest-Viasure, BioVendor-fastGEN, Dynamiker, PathoNostics, Genes2me), generating distribution markup revenue alongside proprietary sales.

Clonit's product architecture spans consumable kits, hardware (automatic and manual DNA/RNA extraction systems branded as Clonext), and software (GENOVESA bioinformatics for NGS interpretation). Most products carry CE-IVD marking and certain distributed ViennaLab products have achieved IVDR (EU 2017/745) certification, supporting continued European institutional sales access as IVDR deadlines approach.

The company employs 11-50 staff and serves healthcare laboratories, hospitals, transplant centers, point-of-care testing facilities, and medical research institutions primarily in Italy, with go-to-market driven by direct B2B field sales supplemented by exclusive distribution partnerships. Pricing is not publicly disclosed; customers must request quotes. Recent commercial activity includes a December 2025 acquisition of Dia.Pro and active trade-fair participation at MEDICA 2025 (Hall 3 - C60) and SIGU 2025, indicating a strategy to deepen both product portfolio and international reach beyond its domestic Italian base.

Name

Clonit

Legal name

CLONIT srl

Website

https://clonit.it

Company type

Private

Founded year

1987

Operating status

Operating

Headcount range

11–50 employees

Short description

Clonit is an Italian biotechnology company (founded 1987, Abbiategrasso, Milan) that develops, manufactures, and distributes molecular in vitro diagnostic kits and instruments, and acts as exclusive Italian distributor for several international IVD brands, serving clinical laboratories, hospitals, transplant centers, and research institutions.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (Molecular Diagnostics)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047), Laboratory Analytical Instruments (3826)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)

Keywords

• Molecular diagnostics
• In vitro diagnostics
• Genetic disease testing
• Infectious disease diagnostics
• NGS cancer panels

Headquarters

HQ city

Milano

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Diagnostic Products: Manufacturing and sale of in vitro diagnostic products for genetic diseases, infectious diseases, oncology, and fungal infections. Revenue generated through direct sales to laboratories and healthcare institutions, supplemented by distribution partnerships.
2. Distributed/Resold Products: Clonit distributes diagnostic products from international manufacturers (Genes2me, Certest, ViennaLab, BioVendor, Dynamiker, PathoNostics) as exclusive Italian distributor, generating revenue through markup on distributed products.
3. Extraction Systems: Sale of automatic and manual DNA/RNA extraction systems and instruments for molecular diagnostics laboratories.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

Clonit researches, develops, and manufactures in vitro diagnostic (IVD) kits based on molecular biology techniques for genetic diseases, infectious diseases, oncology, and fungal infections. Its proprietary and distributed portfolio includes Real-Time PCR kits, NGS cancer panels (fastGEN), immunochromatographic rapid tests, ELISA, CLIA, and LFA assays, supplemented by DNA/RNA extraction instruments and the GENOVESA bioinformatics software. The company also acts as the exclusive Italian distributor for several international diagnostic brands, offering clinical laboratories and hospitals a single-source molecular diagnostics solution.

Product overview

Clonit is an Italian biotech company (founded 1987) specializing in molecular biology in vitro diagnostics. The company offers a diversified portfolio of diagnostic products organized into several categories: Genetic Diseases tests (including HLA typing for celiac disease, cardiovascular, pharmacogenetics, and neurological disorders), Infectious Diseases tests (covering transplantation, respiratory infections, tropical diseases, STDs, and nosocomial infections), Oncology products (including fastGEN NGS kits from Biovendor for solid, lung, brain, and hematological cancers, plus BCR::ABL1 fusion gene detection), and Fungal Infections diagnostics (from Dynamiker and PathoNostics including PCR assays, ELISA, CLIA, and POCT solutions). Clonit also distributes products from partner companies including ViennaLab Diagnostics, Certest-Viasure, and Genes2me, and offers extraction systems. The company serves the global in-vitro diagnostics market with CE/IVD marked products, with some products under IVDR certification.

Differentiator

Problem solved

Functional benefit

Products and services

• Gluten DQuick DResolution v4 Advanced HLA typing test for celiac disease risk assessment using molecular biology techniques, targeted at clinical laboratories performing genetic disease diagnostics.
• Genetic Diseases Test Portfolio Molecular diagnostic tests for genetic disorders including cardiovascular diseases, hemochromatosis, male infertility, celiac disease, pharmacogenetics, neurogenetic disorders, Fragile X syndrome, chromosome aneuploidies, and recurrent spontaneous abortion, targeted at clinical laboratories and genetic testing centers.
• Transplantation Panel In vitro diagnostic tests for identifying pathogens relevant to transplantation patient monitoring, for use by transplant centers and hospital diagnostic laboratories.
• Respiratory Infections Test Portfolio Molecular diagnostic tests for respiratory infection pathogens, serving clinical laboratories and hospital diagnostics departments.
• fastGEN NGS Cancer Mutation Kits Next-generation sequencing kits from BioVendor for ultra-deep amplicon sequencing of cancer-related genes (KRAS, NRAS, BRAF, EGFR, IDH 1/2, CFTR, POLE/CTNNB1, PIK3CA, TP53, BCR::ABL1), distributed by Clonit for clinical and research laboratories performing solid tumor and hematological cancer mutation analysis.
• GENOVESA Bioinformatics Software All-in-one bioinformatics solution for raw NGS data analysis (FASTQ files), with advanced quality control, automatic low-coverage region notification, monthly database updates, and one-click reporting, distributed alongside fastGEN kits for clinical and research laboratories.
• Fungal Infections Diagnostic Portfolio Diagnostic tests for fungal infections including Aspergillus, Candida, Candida auris, Mucor, Pneumocystis jiroveci, and Talaromyces marneffei, combining PCR assays, ELISA, CLIA, POCT systems, and the AsperGenius resistance multiplex real-time PCR kit for azole resistance detection.
• DNA/RNA Extraction Systems Automatic and manual DNA/RNA extraction systems and instruments used by molecular diagnostics laboratories to prepare samples for downstream PCR and NGS workflows.
• Immunochromatographic Rapid Tests Rapid point-of-care immunochromatographic diagnostic tests for healthcare settings requiring quick turnaround, including Dynamiker carbapenem-resistant Enterobacteriaceae and fungal antigen assays.
• ViennaLab Diagnostics Distributed Products In vitro diagnostic tests for genetic disorders, predispositions, pharmacogenetics, cancer, and human microbiome testing, distributed by Clonit as the exclusive Italian partner of ViennaLab Diagnostics.
• Certest Viasure Real-Time PCR Kits Real-Time PCR kits distributed by Clonit as part of the Certest Viasure complete solution for streamlined molecular diagnostics workflow, complementing infectious disease diagnostics.
• Genes2me OnePCR Detection System All-in-one molecular detection system from Genes2me, distributed by Clonit, providing a complete PCR-based detection workflow for molecular diagnostic laboratories.

Quantifiable outcome

• Acquisition of Dia.Pro announced December 2025, strengthening position in global in-vitro diagnostics landscape

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core.

• Dia.ProcoreStrategic or Co-development Partner · 1 December 2025Clonit announced the acquisition of Dia.Pro in December 2025, described as a strategic milestone that strengthens Clonit's position in the global in-vitro diagnostics landscape.
• ViennaLab DiagnosticscoreChannel Partner/ Reseller/ DistributorClonit is the exclusive Italian distributor for ViennaLab Diagnostics, a Vienna-based company specializing in in vitro diagnostic tests. ViennaLab develops customized solutions for genetic testing, from simple single marker detection to complex genetic analysis, covering genetic disorders, predispositions, pharmacogenetics, cancer, and human microbiome testing. ViennaLab kits are CE/IVD marked with some products already achieving IVDR certification.
• Certest - ViasurecoreChannel Partner/ Reseller/ DistributorClonit distributes Certest Viasure Real-Time PCR kits, providing a complete solution for streamlined molecular diagnostics workflow. Viasure products complement Clonit's infectious disease diagnostic portfolio.
• Genes2mecoreChannel Partner/ Reseller/ DistributorClonit distributes Genes2me products including OnePCR, an all-in-one detection system. Genes2me provides molecular diagnostic solutions that expand Clonit's product offerings.
• BioVendor - fastGENcoreChannel Partner/ Reseller/ DistributorClonit distributes BioVendor's fastGEN product line featuring NGS-based cancer mutation analysis kits for KRAS, NRAS, BRAF, EGFR, IDH 1/2, CFTR, POLE/CTNNB1, PIK3CA, and TP53 genes. Includes GENOVESA bioinformatic analysis software for data interpretation.
• DynamikercoreChannel Partner/ Reseller/ DistributorClonit distributes Dynamiker fungal infection diagnostic products including (1-3)-β-D-Glucan assays, ELISA tests, CLIA tests, POCT systems, and MycoMDx PCR Real-time assays for Aspergillus, Candida, Candida auris, Mucor, Pneumocystis jiroveci, and Talaromyces marneffei detection.
• PathoNosticscoreChannel Partner/ Reseller/ DistributorClonit distributes PathoNostics fungal infection products including AsperGenius Resistance Multiplex real-time PCR kit for detecting Aspergillus species and resistance markers (L98H/TR34 and TR46/Y121F/T289A mutations conferring azole resistance).

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• QIAGEN: Global molecular diagnostics and sample technologies company with deep PCR and genetic-testing kits including IVDR-compliant assays; broad incumbent competing for the same Italian clinical laboratory customers Clonit serves.
• DiaSorin: Italian-headquartered global IVD company with a broad immunodiagnostics and molecular diagnostics portfolio; directly overlaps with Clonit's clinical diagnostics focus and shares the Italian manufacturing heritage, though at vastly greater scale.
• ELITechGroup: European-headquartered IVD group with molecular biology, clinical chemistry and bioreagent product lines serving hospital and reference labs; comparable to Clonit's PCR-based portfolio and Italian market presence at meaningfully larger scale.

Direct peers

• Certest Biotec: Spanish manufacturer of real-time PCR kits (Viasure line) for infectious disease; one of Clonit's principal distribution partners and a direct comparable in the molecular infectious-diagnostics product category.
• Dynamiker: Chinese IVD manufacturer of fungal-infection, antimicrobial-resistance and POCT kits distributed by Clonit in Italy; comparable in molecular and immunoassay IVD manufacturing and export-oriented distribution model.
• ViennaLab Diagnostics: Vienna-based IVD developer of CE/IVD and IVDR genetic testing kits; Clonit is its exclusive Italian distributor, and the two sit in the same molecular-genetics product category serving similar clinical lab customers.
• BioVendor: Czech-headquartered diagnostics and research reagent company whose fastGEN NGS oncology kits are distributed by Clonit in Italy; comparable in offering molecular diagnostic and life-science reagent kits to clinical and research customers.
• PathoNostics: Dutch molecular diagnostics company focused on fungal infection PCR kits (e.g., AsperGenius); a Clonit distribution partner and a direct comparable in the niche molecular mycology IVD space.
• Genes2me: Indian molecular diagnostics company whose OnePCR all-in-one detection system is distributed by Clonit; comparable as a molecular IVD manufacturer targeting international distribution partners and clinical labs.
• Dia.Pro Diagnostic Bioprobes: Italian IVD manufacturer recently acquired by Clonit (Dec 2025); historically a direct peer and now a wholly-owned subsidiary, providing overlapping ELISA and infectious-disease diagnostics to Italian labs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xlinkedin.com/company/clonit-srl
• LinkedInlinkedin.com/company/clonit-srl

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

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 Clonit