BioPorto Diagnostics

What BioPorto Diagnostics does

BioPorto Diagnostics A/S is a Danish in vitro diagnostics company focused on NGAL (Neutrophil Gelatinase-Associated Lipocalin) biomarker-based tests for acute kidney injury (AKI) risk assessment and diagnosis. Founded in 1995 and headquartered in Hellerup, Denmark with US operations in Boston, BioPorto develops and sells diagnostic assays that detect kidney damage within 1-2 hours — significantly earlier than the 24-72 hour window of conventional serum creatinine-based methods. The company is publicly listed on Nasdaq Copenhagen under the ticker BIOPOR (ISIN: DK011048619) and operates with a small headcount of 11-50 employees.

The product portfolio centers on the FDA-cleared ProNephro AKI (NGAL) test for pediatric use, the CE-marked The NGAL Test for EU and other international markets, research-grade NGAL ELISA kits across six species, the gRAD lateral flow assay development platform, and (until April 2026) NGAL antibodies. Core technology is particle-enhanced turbidimetric immunoassay (PETIA) compatible with standard automated clinical chemistry analyzers, including Roche's Cobas c 501.

BioPorto operates a dual-channel go-to-market model: exclusive global distribution through Roche Diagnostics for clinical chemistry analyzer placements combined with a direct US sales organization. Revenue streams are primarily one-time unit sales of test kits, ELISA kits, and (historically) antibodies, priced on a quote-based, volume-tied basis. FY2025 revenue reached DKK 40.3 million (+11% YoY), with NGAL-specific revenue at DKK 28.2 million (+22% YoY). Primary end customers are hospital clinical laboratories, ICU/ED departments, and nephrology specialists; secondary customers include academic research institutions and pharmaceutical companies. The company is pursuing FDA clearance for adult NGAL use, with a pre-submission filed in March 2026 and a validation study initiated June 2026, under a 'Forward' strategic plan targeting DKK 150-200 million revenue by 2028.

Name

BioPorto Diagnostics

Legal name

BioPorto Diagnostics A/S

Website

https://bioporto.com

Company type

Public

Founded year

1995

Operating status

Operating

Headcount range

11–50 employees

Short description

BioPorto Diagnostics is a Danish in vitro diagnostics company that develops NGAL biomarker tests for early acute kidney injury detection, serving hospital laboratories, ICU/ED departments, nephrology specialists, and research institutions globally via Roche Diagnostics distribution and direct US sales.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Renal Diagnostics & Monitoring (eGFR/Creatinine POC, Urine Analyzers, BP/Fluid Status) (HLAHAKAJ)

akta.pro secondary industry

Urinalysis & Routine Screening Diagnostics (HLAHAAAG)

Keywords

• Acute kidney injury diagnostics
• NGAL biomarker assays
• In vitro diagnostics
• Kidney injury risk assessment
• Biomarker test kits

Headquarters

HQ city

Copenhagen

HQ country

Denmark

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. NGAL Diagnostic Test Sales: Sale of ProNephro AKI (NGAL) tests for acute kidney injury detection, representing the primary revenue driver. Revenue from NGAL-specific products reached DKK 28.2 million, showing consistent commercial traction in hospital laboratories.
2. ELISA Kit Sales: Sale of research-grade and clinical-grade NGAL ELISA (Enzyme-Linked Immunosorbent Assay) kits to research institutions, pharmaceutical companies, and clinical laboratories for biomarker research and diagnostic development applications.
3. Antibody Product Sales: Following acquisition of antibody business from Janel Life Sciences, BioPorto generates revenue from sale of NGAL-specific antibodies to diagnostic manufacturers, research institutions, and pharmaceutical companies for use in assay development and clinical testing.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

BioPorto Diagnostics develops and sells NGAL biomarker-based in vitro diagnostic tests and research tools for the early detection and risk assessment of acute kidney injury (AKI). Its flagship product, ProNephro AKI (NGAL), is an FDA-cleared test for pediatric AKI risk assessment distributed globally through Roche Diagnostics for use on the Cobas c 501 clinical chemistry analyzer. The company also markets the CE-marked NGAL Test, ELISA kits for preclinical research, NGAL-specific antibodies, and the gRAD lateral flow assay development platform.

Product overview

BioPorto Diagnostics is an in vitro diagnostics company offering a focused portfolio of NGAL (neutrophil gelatinase-associated lipocalin) biomarker-based products for acute kidney injury (AKI) detection and risk assessment. The product line includes: ProNephro AKI (NGAL) as the FDA-cleared pediatric AKI risk assessment test distributed through Roche Diagnostics; The NGAL Test as the CE-marked in vitro diagnostic version for use in the EU and other registered countries; NGAL ELISA Kits for research use across six species supporting preclinical studies and Phase 1 clinical trials; gRAD as a lateral flow assay development platform for custom rapid tests; and NGAL Antibodies available via Antibodies Inc. for assay development. The company operates primarily in the clinical diagnostics space with products designed for automated clinical chemistry analyzers.

Differentiator

Problem solved

Functional benefit

Brands

• ProNephro AKI: FDA-cleared biomarker test for pediatric acute kidney injury risk assessment. Available through Roche Diagnostics for the Cobas c 501 clinical chemistry analyzer.
• The NGAL Test
• gRAD Lateral Flow

Products and services

• ProNephro AKI (NGAL) FDA-cleared biomarker test for pediatric acute kidney injury risk assessment, available globally through Roche Diagnostics for the Roche Cobas c 501 clinical chemistry analyzer; designed for hospital clinical laboratories treating critically ill and pediatric patients at risk of AKI.
• The NGAL Test CE-marked in vitro diagnostic particle-enhanced turbidimetric immunoassay for quantitative determination of NGAL in human urine, EDTA plasma, and heparin plasma, designed to run on standard automated clinical chemistry analyzers and registered for diagnostic use across EU, Canada, Korea, and Israel.
• NGAL ELISA Kits Ready-to-use enzyme-linked immunosorbent assay kits for quantifying NGAL in urine, plasma, and serum across six species, supporting preclinical animal research, nephrotoxicity investigations during drug development, and Phase 1 human clinical trials.
• gRAD Lateral Flow Patented generic Rapid Assay Device - a lateral flow strip platform for custom test development that delivers results in approximately 15 minutes across different sample types with single or multiplex detection capability.
• NGAL Antibodies Monoclonal and polyclonal antibodies targeting NGAL for multiple species used by diagnostic manufacturers and researchers to develop immunoassays for kidney disease; the antibody business was divested to Janel Life Sciences in April 2026.

Quantifiable outcome

• NGAL biomarker rises within 1-2 hours of kidney injury, compared to 24-72 hours for serum creatinine elevation
• +1 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature4 records

Partnerships

Four partnerships are on record, tiered core.

• ProPharmacoreImplementation/ SI/ Consulting Partner · 1 April 2023ProPharma serves as the CRO (Contract Research Organization) for BioPorto's US adult clinical study of the NGAL test. ProPharma provides clinical operations, site management, monitoring, and regulatory support services for the FDA submission process targeting expanded adult indication for the NGAL biomarker test.
• Roche DiagnosticscoreChannel Partner/ Reseller/ Distributor · 1 December 2019Roche Diagnostics serves as the exclusive global distributor for BioPorto's ProNephro AKI (NGAL) test for use on the Cobas c 501 clinical chemistry analyzer. This partnership leverages Roche's extensive hospital laboratory network to enable global commercialization of the NGAL acute kidney injury diagnostic test, with Roche handling distribution, sales support, and customer service for laboratory customers worldwide.
• Janel Life Sciences, LLCcoreStrategic or Co-development PartnerBioPorto acquired the antibody business from Janel Life Sciences, LLC, expanding its portfolio of NGAL-specific antibodies for diagnostic and research applications. This acquisition provides BioPorto with proprietary antibody reagents to support its diagnostic test manufacturing and positions the company to serve the research antibody market.
• Massachusetts General HospitalcoreStrategic or Co-development PartnerMassachusetts General Hospital is a key clinical investigation site for BioPorto's US adult clinical study of the NGAL test for acute kidney injury detection. Dr. Andrew Allegretti serves as principal investigator for the study, which is evaluating the performance of NGAL for detecting AKI in adult patients in critical care and perioperative settings.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• bioMérieux: bioMérieux acquired Astute Medical, whose NephroCheck test is the most direct commercial competitor to BioPorto's NGAL-based AKI biomarker in both adult and pediatric hospital settings. Both companies sell immunoassay-based kidney injury diagnostics to clinical laboratories and pursue the same hospital nephrology and critical-care buyers.
• Randox Laboratories: Randox is a specialty IVD manufacturer offering renal and kidney-injury biomarkers on its Evidence and Discovery platforms, with a comparable business model of selling focused biomarker assays to hospital and reference laboratories globally.
• Bio-Techne: Bio-Techne (formerly Techne) sells research-grade kidney biomarker ELISA kits and antibodies, directly overlapping with BioPorto's pre-divestiture research tools business and continuing to compete in the preclinical and translational nephrology research market.
• DiaSorin: DiaSorin is a specialty IVD company offering immunoassays on LIAISON platforms, including renal and kidney-related biomarkers. Its specialty-IVD focus, clinical chemistry distribution model, and hospital laboratory customer base closely mirror BioPorto's go-to-market approach.

Broad incumbents

• Abbott Diagnostics: Abbott is a global IVD incumbent whose ARCHITECT and Alinity ci platforms host kidney-function and renal-injury assays (including creatinine-based tests). It competes with BioPorto for hospital laboratory wallet share on routine chemistry panels and represents the broad incumbent alternative to a focused NGAL franchise.
• Siemens Healthineers: Siemens Healthineers offers Atellica and ADVIA Centaur clinical chemistry platforms with renal diagnostic assays and is a major IVD incumbent serving the same hospital laboratories that BioPorto targets. Its scale and installed base represent the primary indirect competitive threat to BioPorto's automated-platform strategy.

Emerging players

• SphingoTec GmbH: SphingoTec is an emerging diagnostics company developing novel kidney-function biomarkers (e.g., penKid/proenkephalin) for AKI and sepsis, directly overlapping with BioPorto's clinical positioning around early kidney-injury detection in critical care.
• Saladax Biomedical: Saladax is a smaller specialty diagnostics company developing immunoassays for clinical decision support, including assays used in critical care settings. It shares BioPorto's niche-IVD commercial model and serves an overlapping hospital laboratory customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks4 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds4 records

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 BioPorto Diagnostics