Sphingotec GmbH
SphingoTec GmbH is dedicated to developing and marketing innovative blood-based protein biomarkers for diagnosis, prediction, and monitoring of acute medical conditions such as acute kidney injury, sepsis, and acute heart failure. Their mission is to translate scientific advancements into routine clinical practice, supporting clinicians in improving patient care through real-time, actionable insights. The company collaborates with medical centers, IVD, and pharma companies to bring these innovations closer to patients, aiming to enhance patient outcomes and address unmet medical needs in critical care.
Industries
Nr. of Employees
small (1-50)
Sphingotec GmbH
SphingoTec GmbH, Hennigsdorf, Germany
Patents
Products
CE IVD microtiter plate assays for blood-based functional biomarkers
High-throughput CE-marked microtiter plate immunoassays using chemiluminescence/immunoluminometric detection to measure blood-based protein biomarkers relevant to acute and critical care.
Commercial point-of-care kidney function assay (partner-distributed)
A rapid, bedside immunoassay for kidney function biomarkers designed for decentralized testing to support timely clinical decisions in acute settings; launched to market via a distribution partner.
Automated analyzer assay adaptation for central laboratories
Development and technical transfer projects to adapt validated biomarker assays for fully automated immunoassay analyzers to enable high-throughput central laboratory testing and broader market access via analyzer platform partners.
CE IVD microtiter plate assays for blood-based functional biomarkers
High-throughput CE-marked microtiter plate immunoassays using chemiluminescence/immunoluminometric detection to measure blood-based protein biomarkers relevant to acute and critical care.
Commercial point-of-care kidney function assay (partner-distributed)
A rapid, bedside immunoassay for kidney function biomarkers designed for decentralized testing to support timely clinical decisions in acute settings; launched to market via a distribution partner.
Automated analyzer assay adaptation for central laboratories
Development and technical transfer projects to adapt validated biomarker assays for fully automated immunoassay analyzers to enable high-throughput central laboratory testing and broader market access via analyzer platform partners.
Services
Manufacture and supply of CE-marked microtiter plate immunoassays for blood-based protein biomarkers under an ISO 13485-aligned quality system, suitable for routine laboratory workflows.
Contract service measurements for research and clinical studies using validated immunoluminometric and microtiter plate assays with optimized protocols and turnaround times.
Out-licensing of validated biomarker analytes and collaboration with diagnostic companies and distribution partners to enable assay commercialization and platform-based distribution.
Collaborative clinical studies with academic and clinical centers, combined with medical/scientific training and technical assistance to implement assays in hospital laboratories and evaluate clinical impact.
Provision of webinars, publications and educational materials to disseminate evidence on biomarker applications and support clinical adoption.
Manufacture and supply of CE-marked microtiter plate immunoassays for blood-based protein biomarkers under an ISO 13485-aligned quality system, suitable for routine laboratory workflows.
Contract service measurements for research and clinical studies using validated immunoluminometric and microtiter plate assays with optimized protocols and turnaround times.
Out-licensing of validated biomarker analytes and collaboration with diagnostic companies and distribution partners to enable assay commercialization and platform-based distribution.
Collaborative clinical studies with academic and clinical centers, combined with medical/scientific training and technical assistance to implement assays in hospital laboratories and evaluate clinical impact.
Provision of webinars, publications and educational materials to disseminate evidence on biomarker applications and support clinical adoption.
Expertise Areas
- Biomarker discovery and translational research
- In vitro diagnostic immunoassay development and CE-marked manufacturing
- Clinical validation, multicenter studies and real-world evidence generation
- Point-of-care testing development and decentralized testing workflows
Key Technologies
- Microtiter plate immunoassays (MTP)
- Chemiluminescence / immunoluminometric sandwich immunoassays
- Point-of-care immunoassay platforms
- Automated immunoassay analyzer adaptation and high-throughput automation
News & Updates
24. KONGRESS DER DEUTSCHEN INTERDISZIPLINÄREN VEREINIGUNG FÜR INTENSIV- UND NOTFALLMEDIZIN E.V. (DIVI)
The 24th Congress of The German Interdisciplinary Association for Intensive and Emergency Medicine (DIVI) is a conference focused on practical and scientific topics related to intensive care and emergency medicine.
42nd Vicenza Course AKI-CRRT-ECOS and Critical Care Nephrology 2024
A course emphasizing new developments in technology, pharmacology, clinical trials, and consensus definitions in critical care.
43rd International Symposium on Intensive Care and Emergency Medicine (ISICEM)
An international symposium organized by the Departments of Intensive Care and Emergency Medicine of Erasme University Hospital, focusing on critical care and emergency medicine.
SphingoTec receives the certificate being compliant with IVDR (EU) 2017/746
Certification of compliance with the European In Vitro Diagnostic Regulation (IVDR).
First licensing agreement for penKid with Boditech Med, Inc.
SphingoTec closed its first licensing agreement for the penKid biomarker with Boditech Med, Inc.
ISO 13485:2016 certification
The company is certified according to ISO 13485:2016 standards for medical device quality management systems.
24. KONGRESS DER DEUTSCHEN INTERDISZIPLINÄREN VEREINIGUNG FÜR INTENSIV- UND NOTFALLMEDIZIN E.V. (DIVI)
The 24th Congress of The German Interdisciplinary Association for Intensive and Emergency Medicine (DIVI) is a conference focused on practical and scientific topics related to intensive care and emergency medicine.
42nd Vicenza Course AKI-CRRT-ECOS and Critical Care Nephrology 2024
A course emphasizing new developments in technology, pharmacology, clinical trials, and consensus definitions in critical care.
43rd International Symposium on Intensive Care and Emergency Medicine (ISICEM)
An international symposium organized by the Departments of Intensive Care and Emergency Medicine of Erasme University Hospital, focusing on critical care and emergency medicine.
SphingoTec receives the certificate being compliant with IVDR (EU) 2017/746
Certification of compliance with the European In Vitro Diagnostic Regulation (IVDR).
First licensing agreement for penKid with Boditech Med, Inc.
SphingoTec closed its first licensing agreement for the penKid biomarker with Boditech Med, Inc.
ISO 13485:2016 certification
The company is certified according to ISO 13485:2016 standards for medical device quality management systems.