The Biomarker Company
SphingoTec develops and markets innovative in vitro diagnostics solutions for novel and proprietary blood-based protein biomarkers. Our aspiration is to effectively translate scientific advancements into routine clinical practice. We develop biomarkers addressing diagnostically underserved critical care conditions such as sepsis, acute heart failure, acute kidney injury, and cardiogenic shock. First and foremost, our portfolio of tests supports better management of critically ill patients, where fast and reliable information is of the essence in taking treatment decisions.
We are a fully integrated diagnostics company: our innovative biomarkers are commercially available on the point of care platform Nexus IB10. The assay portfolio for near-patient testing goes beyond innovation: on the Nexus IB10 platform, clinicians can deploy a wide range of commonly used parameters in acute and critical care settings, making the analyzer a useful addition to intensive care units (ICU), emergency departments (ED), and other near-patient settings.
Our Mission
To improve patient outcomes with innovative diagnostic solutions for acute care and preventive medicine.
Actionable insights in real-time.
Certified Quality
SphingoTec is committed to providing products that meet and exceed customer and regulatory requirements.
We produce our products in accordance with EN ISO 13485:2016.
ISO 13485 Certificate (English) ISO 13485 Certificate (German)
Innovative biomarkers
Kidney function biomarker
Proenkephalin A 119-159 (penKid)
The limitations of the current standard of care diagnostics are well known, thus the need to implement new biomarkers to assist a better management of acute kidney injury. Timely information on kidney function is crucial to early initiate nephro-protective strategies.
Endothelial function biomarker
Bioactive adrenomedullin 1-52 (bio-ADM)
Endothelial dysfunction is a hallmark of many critical care conditions such as sepsis and acute heart failure. Loss of endothelial function is causing the formation of edema, shock and subsequent organ failure.
Cardiac depressant factor
Dipeptidyl peptidase 3 (DPP3)
Recent studies have shown that the release of the cardiac depressant factor dipeptidyl peptidase 3 (DPP3) into the bloodstream plays a major role in sudden organ failure.
Headquarter in Hennigsdorf, Germany
SphingoTec GmbH is a privately held company with its headquarter in Hennigsdorf near Berlin and a wholly owned subsidiary in San Diego, CA, USA. The headquarter has a long history of biomarker discovery, development, and validation and is the legal manufacturer of the microtiter plate assays. The German company is leading the global commercialization of the diagnostic solutions with a clear goal: improving patient management and reducing healthcare costs
Manufacturing facility in San Diego, US
Nexus Dx Inc., a wholly-owned subsidiary of SphingoTec, located in San Diego, CA, USA, is a global provider of a near-patient testing system and diagnostic solution. Fully compliant to ISO13485:2016 regulations, Nexus Dx is improving patient care by providing the medical community with rapid and reliable information at the point of care, delivering patient information when and where it is needed most.
Diagnostic platforms
Nexus IB10 point of care analyzer
The Nexus IB10 point of care (POC) technology provides test results in about 20 minutes and can be flexibly deployed in emergency departments, intensive care units, and other near-patient settings. The Nexus IB10 is an in vitro immunology analyzer that quantitatively measures analytes in whole blood or plasma samples on a consumable disc. The POC platform can perform up to three diagnostic parameters at once. The rapid test portfolio includes commonly used parameters in critical care settings as well as the innovative biomarkers penKid, bio-ADM, and DPP3.
Microtiter plate assay
The innovative biomarkers are available as CE IVD microtiter plate (MTP) assays. The MTP is a standard tool in analytical research and labo- ratories. It is a high throughput solution, allowing the measurement of 41 patient samples at once. SphingoTec’s MTP assays are based on a chemiluminescence sandwich immunoassay technology.
History
2022
Product launch: CE IVD microtiter plate test for DPP3
2022
SphingoTec is offically certified to DIN EN ISO 13485:2016
2020
The novel biomarkers are introduced in routine measurements in European university hospitals.
2020
Nexus IB10 portfolio marketed through SphingoTec’s distributor network.
2020
Over 100.000 patients have been measured with our biomarker tests.
2019 - 2020
Product launches: CE-IVD point of care tests for penKid, bio-ADM and DPP3.
2018
Financing round: 25 million euro growth capital. Investors: HBM, Wellington Partners and ILB.
2018
SphingoTec acquires Nexus Dx Inc. from Samsung.
2016
CE-IVD microtiter plate tests for penKid and bio-ADM launched.
2011 - 2013
Bio-ADM and penKid product development. First clinical validation.
2003 - 2006
Biomarker discovery (penKid, bio-ADM) and prototype develoment. First patent applications.
2002
SphingoTec GmbH was founded by Dr. Andreas Bergmann.