Poly Diagnostics

What Poly Diagnostics does

Poly Diagnostics Sarl is a privately held, Luxembourg-based manufacturer of in vitro diagnostic (IVD) molecular diagnostic reagents, founded in 2020 and operating from the House of BioHealth in Esch-sur-Alzette. The company designs, develops, manufactures and distributes — entirely in-house within the European Union — a portfolio of more than 225 Real-Time PCR kits and companion extraction kits across 17 disease categories (respiratory, gastrointestinal, sepsis, meningitis, sexual health, antimicrobial resistance, TORCH, HPV, tropical/vector-borne, veterinary, etc.) covering more than 250 pathogen targets. Assay formats span Duplex (pathogen + RNase P control), Multiplex (three or more targets), and syndromic Panels (e.g., Respiratory Infection Panels I–VII, TORCH Panel, Sepsis Panels, Gastrointestinal Panels I–IV), with both CE IVDR-marked and RUO-labeled SKUs.

Product economics rest on direct B2B sales of reagent kits to professional clinical laboratories, with no public pricing, no third-party distributors, and ordering routed exclusively through a secure, approval-gated customer portal using quote-based pricing and pay-as-you-go billing. Sales, technical support, and business inquiries are handled through dedicated email channels (sales@, support@, [email protected]) supported by a single phone line. Marketing is lean and primarily website-driven (polydiagnostics.com), with no public social media presence and no app, API, SDK, or third-party integrations disclosed.

The company's regulatory positioning — ISO 13485:2016 certification (valid through 2028-12-11) and CE IVDR certification under EU Regulation 2017/746 for Class B and C devices (effective 2026-04-23, valid through 2031-04-22), both audited by TÜV SÜD Product Service GmbH — is its principal commercialization lever and the foundation for distributing products across the European Economic Area. Operations are supported by GMP-aligned laboratory infrastructure within House of BioHealth. No subsidiaries, no disclosed funding rounds, no acquisitions, no executive biographies, and no M&A or partnership history beyond the TÜV SÜD notified-body relationship are present in the source material, leaving the capital structure and ownership undisclosed.

Name

Poly Diagnostics

Legal name

Poly Diagnostics Sarl

Website

https://polydiagnostics.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Poly Diagnostics Sarl is a Luxembourg-based, in-house European manufacturer of CE IVDR-certified Real-Time PCR molecular diagnostic kits and extraction reagents, sold directly via a secure portal to professional clinical laboratories across more than 225 SKUs and 17 disease categories.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics / In Vitro Diagnostic Reagents

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industry

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)

Keywords

• Molecular diagnostic kits
• Real-time PCR reagents
• Infectious disease testing
• In vitro diagnostics
• Clinical laboratory reagents

Headquarters

HQ city

Luxembourg

HQ country

Luxembourg

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales, Others

Revenue model

1. PCR Diagnostic Kit Sales: Sale of molecular diagnostic reagent kits (Real-Time PCR, Duplex, Multiplex, and Panel formats) to professional clinical laboratories. All products listed as 'On request' pricing, indicating direct sales model with quotation-based ordering through customer portal.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Poly Diagnostics is a European manufacturer of in vitro diagnostic medical devices, designing and producing molecular diagnostic kits for professional clinical laboratories. The portfolio centres on Real-Time PCR kits offered in Duplex, Multiplex, and Panel formats, complemented by nucleic acid extraction kits for sample preparation, and covers more than 225 diagnostic kits across more than 250 pathogen targets in 17 infectious-disease categories. All products are CE IVDR-certified under EU Regulation 2017/746, ISO 13485:2016 compliant, and researched, developed, and manufactured entirely in Luxembourg (EU).

Product overview

Poly Diagnostics is a European manufacturer of in vitro diagnostic medical devices offering a portfolio of CE IVDR-certified molecular diagnostic kits. The product portfolio centers on Real-Time PCR Kits available in three formats: Duplex (two-target detection), Multiplex (three or more targets), and Panel (comprehensive syndromic panels combining multiple assays). These are complemented by Extraction Kits for nucleic acid preparation. All products are designed and manufactured in Luxembourg, certified to ISO 13485, and CE-marked under IVDR (EU Regulation 2017/746). The kits target professional clinical laboratories across 17 diagnostic categories spanning antimicrobial resistance, blood pathogens, dermatophytes, eye infections, fungi, gastrointestinal infections, genetics, HPV, meningitis, respiratory infections, sepsis, sexual health, TORCH, tropical/vector-borne diseases, and veterinary pathogens, with coverage of over 250 pathogen targets.

Differentiator

Problem solved

Functional benefit

Products and services

• Real-Time PCR Kits (Duplex) CE IVDR or RUO-labeled duplex real-time PCR assay kits detecting two targets (one pathogen plus RNase P internal control) across infectious disease categories including respiratory, gastrointestinal, sexual health, tropical diseases, and other areas; sold to professional clinical laboratories.
• Real-Time PCR Kits (Multiplex) CE IVDR or RUO-labeled multiplex real-time PCR assay kits detecting three or more targets simultaneously, including influenza panels, coronavirus panels, parainfluenza panels, Candida and Cryptosporidium panels, E. coli pathotyping, and antimicrobial resistance detection assays; sold to professional clinical laboratories.
• Real-Time PCR Kits (Panel) CE IVDR-certified comprehensive panel kits combining multiple assay types for syndromic diagnosis, including Respiratory Infection Panels (I-VII), Gastrointestinal Disease Panels (I-IV), TORCH Panel, Meningitis Panels (I-III), Sepsis Panels (I-II), Sexual Health Panels (I-II), Tropical Diseases Panels (I-II), HPV Genotyping Panel I, Antimicrobial Resistance Panel I, and Candidiasis Panel I; sold to professional clinical laboratories.
• Extraction Kits Nucleic acid extraction kits for sample preparation prior to PCR amplification, supporting the molecular diagnostic workflow from sample to result; sold to professional clinical laboratories.
• Veterinary Pathogen PCR Kits Veterinary-specific PCR diagnostic kits such as African Swine Fever Virus (ASFV) detection assay, designed for animal health diagnostics; sold as part of the veterinary pathogens product category.

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• TÜV SÜD Product Service GmbHcoreStrategic or Co-development PartnerTÜV SÜD serves as the Notified Body (0123) for Poly Diagnostics' CE IVDR certification and ISO 13485 quality management system certification. They perform independent audits and issue certifications for the company's in vitro diagnostic medical devices, ensuring compliance with EU regulations and international standards.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• QIAGEN: One of the largest molecular diagnostics and life science tools companies, with a deep PCR/sample-prep reagent portfolio and broad infectious-disease menu. Highly comparable to Poly Diagnostics in product category (PCR-based IVD reagents for infectious disease) but vastly larger and broader in scope.
• bioMérieux: Global in vitro diagnostics leader whose BioFire FilmArray syndromic panels dominate molecular infectious-disease testing. Comparable in disease-area focus (respiratory, GI, meningitis, sepsis) but operates at vastly larger scale with integrated instrument platforms.
• Roche Diagnostics: Operates the cobas and LightCycler molecular diagnostic systems, including large infectious-disease PCR menus. Comparable pathogen coverage but operates via proprietary instruments rather than open-reagent kits.
• Cepheid (Danaher): Maker of the GeneXpert sample-to-answer molecular system used widely across European clinical labs for infectious-disease PCR. Comparable in disease-area menu and lab channel but sells automated cartridges rather than standalone reagents.

Direct peers

• R-Biopharm: German diagnostics company with a sizable PCR-based clinical and food/clinical pathogen testing portfolio. Comparable on European mid-market IVD manufacturing footprint, broad infectious-disease menu, and B2B lab sales.
• Seegene: Korean molecular diagnostics specialist whose Allplex multiplex syndromic panels (respiratory, GI, STI, meningitis) closely mirror Poly Diagnostics' Multiplex and Panel SKUs. Direct overlap on multiplex PCR chemistries for infectious disease syndromic testing.
• GeneProof: Czech IVD manufacturer specializing in PCR kits for infectious diseases (respiratory, STI, hepatitis, transplant, sepsis) with CE/IVD marking. Closely matches Poly Diagnostics on size, EU base, single-plex + multiplex catalogue, and clinical-lab GTM.
• AB Analitica: Italian IVD manufacturer producing real-time PCR kits for infectious disease (sexually transmitted, respiratory, etc.) with CE marking. Closely comparable to Poly Diagnostics as another mid-size European PCR reagent specialist.
• TIB Molbiol: Berlin-based specialist in LightMix PCR kits for infectious disease, including emergency/rare-pathogen assays. Most directly comparable to Poly Diagnostics in terms of size, European focus, B2B-to-lab distribution model, and a large single-plex/duplex LightMix catalogue.

Regional players

• Diagenode (Hologic): Belgium-based molecular biology and diagnostics company (now part of Hologic) producing real-time PCR kits and reagents for clinical and research use in Europe. Comparable on European molecular diagnostics footprint and B2B clinical lab focus.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/poly-diagnostics

Compliance2 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 Poly Diagnostics