IVY Diagnostics

What IVY Diagnostics does

IVY Diagnostics Srl is an Italian medical device company headquartered in Siena, Italy, specializing in Point of Care Testing (POCT) instruments, high-end rapid diagnostic tests, OTC self-tests, and laboratory instruments. Founded over 20 years ago and operating as a private Srl, the company maintains a catalog spanning proprietary IVY-branded POCT analyzers (DP-H10 hematology analyzer, easyFIA immunofluorescence analyzer, easyTOX drug-of-abuse cup reader, Altispeed urine analyzer, POINTCARE M4 clinical chemistry analyzer, Flurolit TRF-based FIA system) alongside distributed partner products (iSED/miniiSED ESR analyzers from ALCOR Scientific, ACRO LF Reader) and a range of CE-IVD/FDA 510(k) cleared rapid tests covering infectious disease, drug of abuse, tumor markers, cardiac markers, women's health, and tropical diseases. The company is ISO 13485 and IEC 62304 compliant and CMDCAS-accredited for the Canadian market.

Name

IVY Diagnostics

Legal name

IVY Diagnostics Srl

Website

https://ivydiagnostics.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

IVY Diagnostics Srl is an Italian POCT device and rapid test manufacturer/distributor serving occupational medicine, clinical laboratories, pharmacies, hospitals, pediatric, forensic, military, and OTC self-testing customers across Europe and the Middle East.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Equipment and Supplies Manufacturing (3391)

SIC

Laboratory Analytical Instruments (3826), Surgical & Medical Instruments & Apparatus (3841), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Drug-of-Abuse & Toxicology Rapid Tests (Urine/saliva panels) (HLAHAOAG)

akta.pro secondary industries

Clinical Chemistry, Hematology & Coagulation Testing (Trial Support) (HLAGAEAE), Pregnancy, Fertility & Women’s Health Rapid Tests (hCG, ovulation, vaginal infection) (HLAHAOAF), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Point of care testing
• Rapid diagnostic tests
• In vitro diagnostics
• Immunofluorescence analyzers
• Hematology analyzers

Headquarters

HQ city

Siena

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. POCT Device Sales: Sale of Point of Care Testing instruments (hematology analyzers, immunofluorescence analyzers, DOA cup readers, urine analyzers, lipid profile analyzers). Devices are sold directly to healthcare facilities, pharmacies, occupational medicine practices, laboratories, and clinics.
2. Rapid Test Kits and Reagents: Sale of rapid diagnostic test kits (CE-IVD certified, FDA 510(k) approved) across categories: infectious diseases, drug of abuse, cardiac markers, tumor markers, women's health, tropical diseases, veterinary diagnostics. Includes single-use reagent packs for POCT devices.
3. Self-Testing / OTC Products: Over-the-counter self-diagnostic tests sold through pharmacies and the company's e-commerce platform (ivymedicalshop.com), including self-testing kits for celiac disease, H. pylori, vitamin D, and combo respiratory tests.
4. Food Supplements: Sale of dietary supplements (immune defense, anti-inflammatory/pain relief, sleep/relaxation, dry/wet cough) launched in 2023. Distributed through pharmacies and the ivymedicalshop.com e-commerce platform.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

IVY Diagnostics manufactures, brands and distributes Point of Care Testing (POCT) analyzers, high-end rapid diagnostic test kits, and laboratory instruments used in occupational medicine, clinical and analytical laboratories, hospitals, clinics, pharmacies, and military/forensic settings. The proprietary IVY-branded portfolio includes hematology, immunofluorescence, clinical chemistry, drug-of-abuse, urine, and lipid profile analyzers, complemented by CE-IVD certified and FDA 510(k) cleared rapid tests for infectious disease, cardiac, tumor, drug-of-abuse, women's health, and veterinary applications, plus OTC self-tests and food supplements sold via pharmacies and e-commerce.

Product overview

IVY Diagnostics is a diagnostic products company offering a comprehensive portfolio of Point of Care Testing (POCT) devices, high-end rapid tests, and laboratory instruments. The product portfolio includes: (1) POCT devices including the DP-H10 hematology analyzer, easyFIA immunofluorescence analyzer, easyTOX drug of abuse reader, Altispeed urine analyzer, POINTCARE M4 clinical chemistry analyzer, ACRO LF Reader, Flurolit fluorescence immunoassay system, and Bioscan/Compass lipid profile analyzers; (2) Rapid tests for drug of abuse, infectious diseases, tumor markers, cardiac markers, and tropical diseases; (3) Laboratory instruments including iSED and miniiSED erythrocyte sedimentation rate analyzers from ALCOR Scientific; (4) OTC self-tests including BIOCARD celiac and helicobacter tests; and (5) Food supplements. Products are CE-IVD certified and FDA 510(k) approved, used in occupational medicine, laboratories, hospitals, clinics, forensic medicine, toxicology, and military forces.

Differentiator

Problem solved

Functional benefit

Brands

• easyFIA: Immunofluorescence analyzer POCT device capable of semi-quantitative/quantitative tests in under 15 minutes
• easyTOX
• DP-H10
• Altispeed
• POINTCARE M4
• Flurolit
• BIOCARD

Quantifiable outcome

• Results in under 5 minutes for DP-H10 hematology analysis
• +5 more outcomes

Named customers7 records

Segments6 records

Ideal customer profiles6 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature11 records

Partnerships

Five partnerships are on record, tiered core, moderate and minor.

• TCS Tecnochimica ServicecoreChannel Partner/ Reseller/ DistributorTCS Tecnochimica Service is an affiliated company (azienda consociata) of IVY Diagnostics, sharing exhibition space at pediatric and occupational medicine congresses. TCS serves as a commercial partner for promoting IVY Diagnostics products to laboratories and pediatricians in Italy.
• ACRO Biotech InccoreTechnology or IntegrationACRO Biotech Inc supplies the ACRO LF Reader (Lateral Flow Reader) distributed by IVY Diagnostics. ACRO is committed to bringing innovative solutions combining ease of rapid tests with modern electronics. IVY distributes this product as part of its POCT portfolio.
• ALCOR Scientific Inc.coreTechnology or IntegrationALCOR Scientific Inc. manufactures the iSED and miniiSED erythrocyte sedimentation rate (VES) analyzers distributed by IVY Diagnostics in Italy. iSED is a 20-position fully automated ESR analyzer; miniiSED is the single-position version, both offering rapid 15-20 second response times.
• PharmaideamoderateChannel Partner/ Reseller/ DistributorPharmaidea, a leading company in the pharmacy sector, shares exhibition space with IVY Diagnostics at Cosmofarma Exhibition. Together they present the DP-H10 hematology analyzer, demonstrating a collaborative GTM approach for the pharmacy market segment.
• WellpharmacyminorChannel Partner/ Reseller/ DistributorWellpharmacy (Dr. Centofante, Via Francesco Grimaldi 40, Rome) partnered with IVY Diagnostics for promotional in-store events including the 'Vitamin D Month' campaign. IVY provided POP materials, posters, and flyers to promote self-testing products at the pharmacy location.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Cortez Diagnostics: U.S.-based distributor and manufacturer of rapid diagnostic tests covering infectious disease, drugs of abuse, pregnancy, cardiac markers, and tumor markers. Closely comparable as a mid-sized rapid-test catalog operator serving clinical, occupational, and OTC channels.
• Trinity Biotech: Irish-headquartered clinical diagnostics company with a portfolio spanning point-of-care hemoglobin A1c tests, infectious disease rapid tests, and autoimmune diagnostics. Directly comparable as a small-to-mid cap IVD/POCT specialist selling into laboratories and clinical channels.
• Meridian Bioscience: U.S.-based diagnostics company focused on molecular and immunoassay rapid tests for infectious diseases, gastrointestinal conditions, and respiratory pathogens. Comparable as a specialty rapid-test manufacturer whose catalog structure (test kits, readers, OEM partnerships) closely mirrors IVY's.
• Response Biomedical: Canadian diagnostics company focused on rapid immunochromatographic and POCT immunoassay tests (RAMP platform) for cardiovascular, infectious disease, and biodefense markers. Closely comparable in scale, product architecture (lateral-flow reader plus consumables), and target customer segments.
• EKF Diagnostics Holdings: UK-listed point-of-care diagnostics company focused on hemoglobin/hematology (HemoControl, QuikRead), rapid tests, and central lab analyzers. Closely comparable business model — proprietary POCT devices paired with consumable reagent kits, distributed across multiple clinical and occupational end-markets.
• Diagnostic Automation / Cortez Diagnostics: Mid-sized rapid-test catalog operator with comparable breadth across infectious disease, DOA, cardiac markers, tumor markers, and women's health rapid tests. Closely comparable go-to-market model — broad multi-category catalog sold through distribution into laboratories, occupational medicine, and clinical channels.
• Alfa Wassermann: Italian in-vitro diagnostics and clinical chemistry company headquartered near Bologna. Directly comparable as a mid-sized Italian IVD manufacturer/distributor with a similar mix of OEM-sourced and proprietary diagnostic instruments, reagent kits, and rapid tests sold into clinical laboratories and occupational medicine channels.

Broad incumbents

• bioMérieux: French in-vitro diagnostics multinational with a portfolio spanning microbiology, immunoassays, and molecular diagnostics. Overlaps with IVY across rapid immunoassays and clinical lab instruments, though operating at substantially greater scale and breadth.
• HORIBA Medical: Subsidiary of Japanese analytical instrumentation group HORIBA, manufacturing hematology, clinical chemistry, and POCT analyzers (including compact hematology systems). Directly comparable in POCT device technology and in offering compact analyzers to clinical labs and physician offices.
• QuidelOrtho: U.S.-based diagnostics major formed by the merger of Quidel and Ortho Clinical Diagnostics, with a broad portfolio of rapid immunoassays (Sofia, Triage), molecular diagnostics, and clinical chemistry systems. Overlaps with IVY across rapid infectious disease, cardiac markers, and women's health rapid tests at meaningfully larger scale.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/ivy-diagnostics-srl

Compliance5 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 IVY Diagnostics