Dia.Pro Diagnostic Bioprobes

What Dia.Pro Diagnostic Bioprobes does

Dia.Pro Diagnostic Bioprobes Srl is an Italian in-vitro diagnostics manufacturer founded in 1996 in Milan (Sesto San Giovanni) that develops, produces, and markets CE-marked immunoassay and molecular diagnostic kits for infectious disease detection. The company operates an internally controlled production cycle spanning cell lines through finished IVD assays, and holds ISO 13485 certification by AEMPS (since 2004) along with qualified supplier status in the GCC, Brazil (ANVISA GMP), and ECOWAS regions, plus country-level Ministry of Health approvals in Argentina, Algeria, Ecuador, Iran, Saudi Arabia, and Venezuela.

The product portfolio spans three technology platforms: ELISA (enzyme immunoassays), CLIA (chemiluminescence immunoassays, branded DIA.CHEMILUX), and RT-PCR (real-time PCR, including lyophilized multiplex kits such as COVID-19 RNA Vs 2). Assay menus cover hepatitis A-E, HIV, blood screening markers, TORCH prenatal screening, tropical diseases (Dengue, Zika, Chikungunya, West Nile, Malaria, T. cruzi), autoimmunity (ENA, ANA panels), and transplantation viral load monitoring (CMV, EBV, BKV, JCV, HHV6/8). The proprietary S.A.R.A. fully automated random access instrument is designed exclusively to run Dia.Pro CLIA reagents, creating a captive reagent pull-through model. ELISA and PCR products are validated on standard third-party thermal cyclers (Bio-Rad CFX96, Applied Biosystems 7500/7300).

The company monetizes through three streams: (1) direct and distributor-based sales of branded IVD products across 100+ countries, (2) OEM production contracts that license access to Dia.Pro's CE Design Dossiers and certification, and (3) technology transfer and R&D services for other IVD companies seeking to extend product ranges or manufacture in emerging markets. Go-to-market is enterprise field sales supported by distributor partnerships and participation in major trade events (MEDICA, ISBT, WHX Labs Dubai). Primary customer segments are blood screening centers and clinical laboratories, with secondary segments in transplantation centers and OEM IVD companies. Dia.Pro is privately held, family/founder-owned with no disclosed institutional investors, no parent company, and no M&A history.

Name

Dia.Pro Diagnostic Bioprobes

Legal name

Dia.Pro Diagnostic Bioprobes s.r.l

Website

https://diapro.it

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

11–50 employees

Short description

Dia.Pro Diagnostic Bioprobes is a privately held Italian IVD manufacturer founded in 1996 that produces CE-marked ELISA, CLIA, and RT-PCR infectious disease assays, plus the proprietary S.A.R.A. CLIA platform, distributed across 100+ countries through direct sales and a global distributor network.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics (IVD)

NAICS

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

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

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

akta.pro secondary industries

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC), Blood Bank, Transfusion Medicine & Immunohematology (HLAHAAAH)

Keywords

• In-vitro diagnostics
• Immunoassay kits
• ELISA assays
• CLIA assays
• RT-PCR kits

Headquarters

HQ city

Sesto San Giovanni

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Product Sales: Sale of CE marked in-vitro diagnostic products including ELISA, CLIA and RT-PCR assays for infectious disease detection
2. OEM Production: OEM production of CE marked DiaPro products through individual contracts of supply, providing customers access to CE Design Dossiers and certification
3. Development and R&D Contracts: Development Projects for Diagnostic systems through skilled professional partnership and R&D contracts in assay development, performance evaluation trials and CE-marking of assays
4. Technology Transfer: Technology Transfer dedicated to companies interested in extending their product range on new devices or manufacturing in emerging countries

Go-to-market motion1 record

Distribution channels3 records

Marketing channels2 records

Core offering

Dia.Pro Diagnostic Bioprobes designs, manufactures, and sells in-vitro diagnostic (IVD) kits and instruments, with a portfolio spanning ELISA, CLIA, and RT-PCR assays. The product range covers disease-specific panels for infectious diseases (including COVID-19, hepatitis, TORCH, tropical diseases, and blood screening), autoimmunity, serology, and transplantation, supported by the proprietary S.A.R.A. Random Access CLIA platform and OEM production services for other IVD companies.

Product overview

Dia.Pro Diagnostic Bioprobes is an Italian IVD manufacturer offering a comprehensive portfolio of immunodiagnostic products across three main technology platforms: ELISA (Enzyme-Linked Immunosorbent Assay), CLIA (Chemi-Luminescence ImmunoAssay), and RT-PCR (Real-Time Polymerase Chain Reaction). The product portfolio covers infectious disease diagnostics including COVID-19, Hepatitis (A-E), HIV, blood screening markers, TORCH infections (for prenatal screening), tropical diseases (Dengue, Zika, Chikungunya, West Nile, Malaria), autoimmune disease markers (ENA and ANA panels), and transplantation monitoring (CMV, EBV, BKV, JCV PCR assays). The company manufactures its own cell lines and reagents, providing OEM production of CE-marked products. CLIA assays require the proprietary S.A.R.A. automated random access instrument, while ELISA and PCR products are validated for use on standard thermal cyclers (Bio-Rad CFX96, Applied Biosystems ABI 7500/7300).

Differentiator

Problem solved

Functional benefit

Brands

• DIA.CHEMILUX: Brand name for CLIA (Chemiluminescence Immunoassay) products including SARS-CoV-2 tests, autoimmune tests, serology tests, TORCH tests, tropical disease tests, and blood screening tests.
• S.A.R.A.

Products and services

• COVID-19 RNA Vs 2 PCR Kit

Quantifiable outcome

• 30+ years of experience in Immuno Diagnostics for infectious diseases

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• bioMérieux: Global IVD incumbent with deep infectious disease, microbiology, and immunoassay portfolios serving hospitals and blood banks worldwide. Competes with Dia.Pro on blood-screening and infectious-disease menus, but at much greater scale and with broader instrument platforms.
• Bio-Rad Laboratories: Major life-science instrumentation and clinical diagnostics company; Dia.Pro's PCR assays are validated for use on Bio-Rad's CFX96 thermal cycler. Direct overlap on ELISA kits, quality controls, and infectious disease testing reagents.
• Roche Diagnostics: World-leading IVD provider with extensive immunoassay (Cobas/CLIA) and PCR menus covering infectious disease, hepatitis, HIV, and transplantation. Competes head-to-head with Dia.Pro for hospital and blood-bank tenders globally.
• Abbott Diagnostics: Global IVD giant offering immunoassays, blood-screening assays, and PCR tests across infectious diseases, hepatitis, and HIV. Represents the largest competitive threat to mid-sized IVD specialists serving blood banks and clinical labs.

Direct peers

• Fortress Diagnostics: UK-based IVD manufacturer producing ELISA and rapid tests for infectious disease, blood screening, and clinical chemistry. Comparable mid-sized IVD business with similar geographic distribution model and product focus.
• Calbiotech: US-based ELISA and CLIA kit manufacturer serving clinical and research laboratories with infectious disease, autoimmune, and hormone panels. Comparable as a niche immunoassay manufacturer targeting clinical labs and OEM partners.
• DiaSorin: Italian-headquartered IVD company focused on immunodiagnostics and molecular diagnostics, with overlapping infectious disease, hepatitis, and TORCH menus. Closely comparable in origin (Italy) and core technology platform (CLIA/ELISA), though substantially larger.
• Wantai BioPharm: Chinese IVD manufacturer with broad infectious disease menus including hepatitis, HIV, and blood-screening assays; large OEM/export footprint. Comparable in scale, product mix, and emerging-market focus.
• CTK Biotech: Rapid test and ELISA-focused IVD manufacturer specializing in infectious diseases (HIV, hepatitis, tropical diseases) for emerging markets. Closely comparable in product mix and target customer segments, particularly in Africa and Latin America.
• HOB Biotech: Chinese IVD manufacturer focused on allergy, autoimmune, and infectious disease immunoassays with an automated CLIA platform. Comparable as a mid-sized IVD player combining proprietary instruments with a reagent menu in infectious and autoimmune disease.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/dia-pro-diagnostic-bioprobes-srl

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

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 Dia.Pro Diagnostic Bioprobes