BioPorto Diagnostics Inc. (US)
BioPorto Diagnostics Inc. (US) is the US commercial subsidiary of Denmark-listed BioPorto A/S, commercializing the first FDA-cleared NGAL biomarker test for pediatric acute kidney injury risk assessment, distributed exclusively through Roche Diagnostics and targeting US pediatric intensive care units.
- Company typePublic
- Founded2000
- HeadquartersNeedham, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What BioPorto Diagnostics Inc. (US) does
BioPorto Diagnostics Inc. (US) is the American commercial subsidiary of Denmark-based BioPorto A/S (Nasdaq Copenhagen: BIOPORTO), operating from Needham, Massachusetts. The company develops and commercializes in-vitro diagnostic tests built on the NGAL (Neutrophil Gelatinase-Associated Lipocalin) biomarker, with its core product being ProNephro AKI (NGAL), a particle-enhanced turbidimetric immunoassay (PETIA) for the quantitative determination of NGAL in human urine, run on the Roche cobas c 501 clinical chemistry analyzer. ProNephro AKI received FDA clearance on December 7, 2023 as the first FDA-cleared test for pediatric acute kidney injury (AKI) risk assessment, supported by the 660-patient multicenter GUIDANCE clinical trial and over 2,500 peer-reviewed publications on the NGAL biomarker.
The company targets pediatric intensive care units (ICUs) in US hospitals, engaging intensivists, nephrologists, and laboratory medicine professionals through clinical education, key opinion leader engagement (including Senior Medical Director Dr. Prasad Devarajan, co-discoverer of NGAL), and presence at major medical congresses (SCCM, ASN Kidney Week, STS, ADLM). In the US, ProNephro AKI is distributed exclusively through Roche Diagnostics; globally, BioPorto also sells NGAL ELISA research kits in six species via its corporate website to pharmaceutical, academic, and clinical research customers. An October 2024 study at Massachusetts General Hospital is evaluating expansion to adult use, which would materially broaden the addressable market.
Revenue mechanics are primarily one-time kit sales (test kits, control kits, calibrator kits) priced on a quote basis and billed under multi-year contracts via Roche, supplemented by research-use ELISA kit sales. US revenue grew 34% in 2024 against 17% overall company growth. Leadership transitions in 2024-2025 (new CEO Carsten Buhl, CFO Niels Høy Nielsen, Chief Legal Officer Gry Husby Larsen) reflect a deliberate commercial scaling phase, with the US identified as the primary growth market.
BioPorto Diagnostics Inc. (US) firmographics
Firmographics- Name
- BioPorto Diagnostics Inc. (US)
- Legal name
- BioPorto Diagnostics Inc.
- Website
- https://bioporto.us
- Company type
- Public
- Founded year
- 2000
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- BioPorto Diagnostics Inc. (US) is the US commercial subsidiary of Denmark-listed BioPorto A/S, commercializing the first FDA-cleared NGAL biomarker test for pediatric acute kidney injury risk assessment, distributed exclusively through Roche Diagnostics and targeting US pediatric intensive care units.
- Ownership category
- akta.pro rank
BioPorto Diagnostics Inc. (US) industry classification
Industry- Product category
- In Vitro Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Renal Diagnostics & Monitoring (eGFR/Creatinine POC, Urine Analyzers, BP/Fluid Status) (HLAHAKAJ)
- akta.pro secondary industry
- Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB)
Keywords
Where BioPorto Diagnostics Inc. (US) is headquartered
LocationHeadquarters
- HQ city
- Needham
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
BioPorto Diagnostics Inc. (US) business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations, Infrastructure
Revenue model
- ProNephro AKI (NGAL) Diagnostic Products: BioPorto generates revenue through the sale of its FDA-cleared ProNephro AKI (NGAL) test kits, control kits, and calibrator kits for use on the Roche cobas c 501 clinical chemistry analyzer. Products are distributed through Roche Diagnostics in the US market.
- Research ELISA Products: BioPorto provides NGAL ELISA kits for research purposes, available in six species, serving as a bridge from pre-clinical research to clinical trials. These products are available globally through the company's main bioporto.com website.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | ProNephro AKI (NGAL) products sold through Roche Diagnostics distribution |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
BioPorto Diagnostics Inc. (US) product offering
Product offeringCore offering
BioPorto Diagnostics Inc. (US) manufactures and commercializes the FDA-cleared ProNephro AKI (NGAL) diagnostic test, a particle-enhanced turbidimetric immunoassay for quantitative determination of NGAL in human urine, used as an aid to identify pediatric patients at risk of developing or having persistent moderate-to-severe acute kidney injury. The test runs on the Roche cobas c 501 analyzer and is distributed in the US through Roche Diagnostics. The company also sells research-use NGAL ELISA kits in six species through its global website.
Product overview
BioPorto Diagnostics Inc. (US) is an in vitro diagnostics company focused on acute kidney injury (AKI) diagnostics. The company's primary product is ProNephro AKI (NGAL), an FDA-cleared test for pediatric AKI risk assessment that runs on the Roche cobas c 501 analyzer. BioPorto also offers a family of NGAL research products including ELISA kits available in six species for pre-clinical and clinical research. The company leverages its expertise in antibodies and assay development to create novel biomarker tests designed to help clinicians identify and manage AKI earlier.
Differentiator
Problem solved
Functional benefit
Brands
- ProNephro AKI (NGAL): The first FDA-cleared test for pediatric acute kidney injury risk assessment - a particle-enhanced turbidimetric immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
Products and services
- ProNephro AKI (NGAL) FDA-cleared particle-enhanced turbidimetric immunoassay for quantitative determination of NGAL in human urine, used as an aid to identify pediatric patients at risk of developing or having persistent moderate-to-severe AKI. Runs on Roche cobas c 501 clinical chemistry analyzer with a 3 µL urine sample and ~10 minute assay time. Distributed through Roche Diagnostics in the US.
- NGAL ELISA Kits Research-use-only ELISA kits for measuring NGAL levels, available in six species for pre-clinical and clinical research applications. These products serve as a bridge from pre-clinical research to clinical trials and are available globally through the company's bioporto.com website.
Quantifiable outcome
- NGAL rises within 2 hours of kidney injury, 2-3 days before serum creatinine changes
- +4 more outcomes
Companies that use BioPorto Diagnostics Inc. (US)
Customer profileNamed customers2 records
Segments5 records
Ideal customer profiles3 records
BioPorto Diagnostics Inc. (US) technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature3 records
BioPorto Diagnostics Inc. (US) partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Roche DiagnosticscoreRoche Diagnostics serves as the exclusive distribution partner for ProNephro AKI (NGAL) in the US market. The test runs on the Roche cobas c 501 clinical chemistry analyzer, which is widely installed in hospital laboratories. This partnership enables BioPorto to leverage Roche's established laboratory distribution network and existing customer relationships. ProNephro AKI received FDA clearance on December 7, 2023, and became available through Roche Diagnostics thereafter.
Scale indicators5 records
Recent moves6 records
Expansion highlights5 records
BioPorto Diagnostics Inc. (US) competitors and assessment
Company assessmentDirect peers
- Bio-Rad Laboratories: Bio-Rad acquired Astute Medical, which commercialized the NephroCheck NGAL test — BioPorto's most direct competitive overlap. Both target AKI risk assessment via NGAL biomarkers, serve ICU/lab settings, and are routed through major IVD distribution channels into US hospitals.
Broad incumbents
- Siemens Healthineers: Siemens Healthineers offers the Atellica/ADVIA Centaur clinical chemistry and immunoassay platforms used in hospital core labs worldwide, with overlapping menu in renal and critical-care biomarkers. Directly comparable as a clinical chemistry IVD incumbent serving the same hospital-customer base BioPorto targets.
- Beckman Coulter Diagnostics: Beckman Coulter (Danaher) provides clinical chemistry and immunoassay analyzers (AU/DxH series) widely installed in US hospital laboratories with overlap in renal and critical-care diagnostics. Directly comparable for distribution through hospital lab channels where BioPorto sells ProNephro AKI.
- Ortho Clinical Diagnostics: Ortho Clinical Diagnostics (now part of QuidelOrtho) operates the Vitros clinical chemistry and immunoassay platform widely used in hospital labs. Comparable IVD incumbent with similar hospital lab customer concentration and clinical chemistry focus.
- Roche Diagnostics: Roche is BioPorto's exclusive US distribution partner AND the analyzer platform (cobas c 501) on which ProNephro AKI runs. Roche also offers a broad IVD menu across chemistry, immunoassays, and cardiac/kidney biomarkers, making it both customer-channel and adjacent portfolio competitor.
- Abbott Diagnostics: Abbott is a major IVD manufacturer with broad clinical chemistry, immunoassay, and critical-care biomarker menus (including kidney injury diagnostics on Architect/Alinity platforms). Comparable to BioPorto as a multi-analyte clinical chemistry IVD player serving hospital labs.
- QuidelOrtho: QuidelOrtho offers clinical chemistry and immunoassay IVDs (Vitros platform) serving US hospital and reference laboratories, with menu overlap in renal and critical-care biomarkers. Comparable as a clinical chemistry IVD incumbent in hospital core labs.
Emerging players
- EKF Diagnostics: EKF Diagnostics markets point-of-care and clinical chemistry diagnostics including kidney injury biomarkers (NGAL, cystatin C). Comparable niche IVD player in renal biomarkers with overlapping biomarker IP and target customer base (hospital labs and critical care).
- Sekisui Diagnostics: Sekisui Diagnostics develops and distributes clinical chemistry and specialty biomarkers, including renal and critical-care assays, often through OEM/partner channels. Comparable as a specialty IVD player leveraging partner distribution into hospital laboratories.
- bioMérieux (Sphingotec): bioMérieux acquired Sphingotec, which develops biomarkers for sepsis, AKI, and acute critical care. Comparable emerging biomarker diagnostics player targeting the same ICU/lab intersection with overlapping critical-care biomarker strategy.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
BioPorto Diagnostics Inc. (US) social profiles
Digital presenceBioPorto Diagnostics Inc. (US) compliance and trust
Trust signalCompliance2 records
BioPorto Diagnostics Inc. (US) financial estimates
Financial estimateRevenue estimate
Valuation estimate
BioPorto Diagnostics Inc. (US) leadership team
Management profileNumber of profiles
Profiles7 records
BioPorto Diagnostics Inc. (US) subsidiaries and ownership
Company hierarchySubsidiaries3 records
BioPorto Diagnostics Inc. (US) funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
BioPorto Diagnostics Inc. (US) M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BioPorto Diagnostics Inc. (US)
What does BioPorto Diagnostics Inc. (US) do?
BioPorto Diagnostics Inc. (US) manufactures and commercializes the FDA-cleared ProNephro AKI (NGAL) diagnostic test, a particle-enhanced turbidimetric immunoassay for quantitative determination of NGAL in human urine, used as an aid to identify pediatric patients at risk of developing or having persistent moderate-to-severe acute kidney injury. The test runs on the Roche cobas c 501 analyzer and is distributed in the US through Roche Diagnostics. The company also sells research-use NGAL ELISA kits in six species through its global website.
Is BioPorto Diagnostics Inc. (US) a public or private company?
BioPorto Diagnostics Inc. (US) is a public company. It is classified as corporate owned and is currently operating.
When was BioPorto Diagnostics Inc. (US) founded?
BioPorto Diagnostics Inc. (US) was founded in 2000. It employs 11 to 50 people.
Where is BioPorto Diagnostics Inc. (US) based?
BioPorto Diagnostics Inc. (US) is headquartered in Needham, United States, in the North America region.
How does BioPorto Diagnostics Inc. (US) make money?
Two revenue lines are on record. ProNephro AKI (NGAL) Diagnostic Products are the primary driver. The others are research ELISA Products.
Who are BioPorto Diagnostics Inc. (US)'s main competitors?
Bio-Rad Laboratories is listed as a direct peer. Broad incumbents are Siemens Healthineers, Beckman Coulter Diagnostics, Ortho Clinical Diagnostics, Roche Diagnostics, Abbott Diagnostics and QuidelOrtho. Emerging players are EKF Diagnostics, Sekisui Diagnostics and bioMérieux (Sphingotec).
Does BioPorto Diagnostics Inc. (US) have an API?
No public API is recorded for BioPorto Diagnostics Inc. (US).
What industry is BioPorto Diagnostics Inc. (US) in?
BioPorto Diagnostics Inc. (US)'s product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAHAKAJ, Renal Diagnostics & Monitoring (eGFR/Creatinine POC, Urine Analyzers, BP/Fluid Status), with a secondary code of HLAFAMAB, Clinical Chemistry & Immunoassay Laboratories. Its NAICS code is 325413 and its SIC code is 2835.