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SphingoTec - The Biomarker Company 

Integrated diagnostic solutions for critical care settings

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

Human kidney cross section on blue, science background.

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.

Three dimensional illustration of blood vessel with flowing erythrocytes and leukocytes.

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

Learn more about our team

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. 

Read more on Nexus Dx

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.

Close-up of multichannel pipette pipetting into microtiter plate in laboratory.

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.

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