SphingoTec and Rivaara Labs Close Exclusive Distribution Agreement for Point of Care Diagnostics in India
• The collaboration focuses on SphingoTec’s near patient diagnostic solution for critical care settings.
• Rivaara gains exclusive rights to market and distribute the Nexus IB10 platform and its rapid tests for innovative biomarkers and commonly used parameters in the Indian subcontinent.
• The Nexus IB10 technology is a “hand-held laboratory” providing fast and reliable diagnostics to support the management of critically ill patients.
• Rivaara gains exclusive rights to market and distribute the Nexus IB10 platform and its rapid tests for innovative biomarkers and commonly used parameters in the Indian subcontinent.
• The Nexus IB10 technology is a “hand-held laboratory” providing fast and reliable diagnostics to support the management of critically ill patients.
Hennigsdorf, Germany and Mumbai, India, March 17, 2022 -
The diagnostic company SphingoTec GmbH (SphingoTec) and Rivaara Labs Pvt Ltd. (Rivaara) today announced that they have entered into a multi-year distribution agreement for the commercialization of SphingoTec’s point of care diagnostic solutions in the Indian subcontinent. The Nexus IB10 analyzer and its portfolio of rapid tests allow convenient assessment of biomarkers relevant in critical care conditions such as sepsis, acute kidney injury, cardiogenic shock, acute heart failure, and myocardial infarction.
Under the terms of the agreement, Rivaara will have the exclusive right to market and distribute SphingoTec’s point of care tests for innovative biomarkers in the Indian subcontinent. This includes the biomarkers proenkephalin (penKid) for the assessment of kidney function (1), bioactive adrenomedullin (bio-ADM) for the assessment of endothelial function (2), and dipeptidyl peptidase 3 (DPP3) a biomarker for cardiac depression (3). The innovative markers are complemented by commonly used parameters such as procalcitonin, troponin, D-dimer, NT-proBNP, and TSH. The biomarkers are made available as rapid tests on the Nexus IB10 bedside technology, a fully automated immunoassay point-of-care instrument, which provides accurate test results within only 20 minutes from whole blood samples. The Nexus IB10 analyzer and its test portfolio can be flexibly deployed in a variety of point of care settings, including emergency departments, intensive care units, and laboratories.
Dr. Angelo Moesslang, Managing Director and Chief Financial Officer of SphingoTec, said, “This distribution agreement is an important step in making our near-patient diagnostics globally available. A point of care solution for acute and critical cases can enable healthcare organizations to maximize diagnostic resources and help clinicians make more informed decisions.”
Mr. Shyamakant Giri, Chief Executive Officer of Rivaara said, “Adding the point of care platform and its rapid tests to our portfolio is increasing the settings in which we facilitate integrated diagnostic testing in the patient-care pathway. Not only are we able to provide well established tests used on a daily basis, but we can also enable access to innovative biomarkers, which address unmet needs in disease areas such as acute kidney injury and sepsis.”
To discover more about the Nexus IB10 and SphingoTec’s portfolio of diagnostic solutions for acute and critical care, please visit www.sphingotec.com. For more information on the Rivaara Labs portfolio, please visit www.rivaaralabs.com
References:
1. Beunders et. al. Proenkephalin (PENK) as a Novel Biomarker for Kidney Function, The Journal of Applied Laboratory Medicine, Volume 2, Issue 3, 1 November 2017, Pages 400–412, doi: https://doi.org/10.1373/jalm.2017.023598
2. Geven et. al. Vascular Effects of Adrenomedullin and the Anti-Adrenomedullin Antibody Adrecizumab in Sepsis, SHOCK: August 2018 - Volume 50 - Issue 2 - p 132-140 doi: 10.1097/SHK.0000000000001103
3. Boorsma et. al. Dipeptidyl peptidase 3, a marker of the antagonist pathway of the renin-angiotensin-aldosterone system in patients with heart failure. Eur J Heart Fail. 2021 Jun;23(6):947-953. doi: 10.1002/ejhf.2158.
About SphingoTec
SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis, and Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression was in-licensed from 4TEEN4 Pharmaceuticals GmbH (www.4teen4.de). IVD tests for SphingoTec’s biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others.
About Rivaara Labs
Rivaara Labs Pvt Ltd. (“Rivaara”, Mumbai, India) is harnessing the power of Molecular diagnostics to bring disruptive, affordable, and innovative need-based diagnostic solutions to India. With an extensive range of test services, Rivaara offers sample-to-answer qualified solutions based on a broad portfolio of automated RT-PCR, IT connectivity, superior analysis, and LIMS interface with actionable clinical reports across infectious diseases, oncology, antibiotic resistance, pathogen detection, inherited disease testing and precision medicine. The solutions address a significant unmet medical need for timely, actionable information that addresses the challenges of the current standard of care for diagnosing and monitoring the diseases. The aim is to develop a strong network of specialized Molecular Diagnostics labs, market novel point of care solutions and build a best-in-class national reference lab. Apart from the investment in infrastructure, Rivaara also invests in highly inspired and motivated human capital within the organization.
Media contact SphingoTec:
Ruxandra Lenz
Sr. Manager Marketing and Communications
SphingoTec GmbH
Neuendorfstr. 15 A
16761 Hennigsdorf
• New ELISA sphingotest® penKid® enables widespread measurement of the kidney function biomarker Proenkephalin 119-159 (penKid) using standard laboratory equipment. • Only available test to match SphingoTec’s reference chemiluminescence assay, developed with patented high-sensitivity technology to provide consistent results across platforms. Hennigsdorf/Berlin, Germany, April 28 2026 - SphingoTec GmbH announces the launch of the ELISA sphingotest® penKid®, a new assay designed to make testing of its proprietary biomarker broadly accessible to research laboratories and pharmaceutical partners. Providing ease-of-use and precision, the test facilitates large-scale investigations of human kidney function in both acute and broader clinical research contexts. Responding to growing research interest The launch follows increasing demand from the scientific community to study penKid - a biomarker reflecting the current state of kidney function in critical care environments. While SphingoTec’s high-sensitivity sphingotest® penKid® assay serves as the reference method for clinical research and third-party IVD assays, the assay technology requiring dedicated equipment was not easily adoptable in research laboratories. The new ELISA sphingotest® penKid® now allows researchers worldwide to benefit from SphingoTec’s patented detection technology using standard photometers, extending penKid testing capability to a wider range of laboratories. Proven performance and data continuity The ELISA sphingotest® penKid® has been developed to achieve excellent correlation with SphingoTec’s reference chemiluminescence assay, ensuring consistent, high-quality results across different assay platforms. Both methods share the same underlying technology capable of detecting penKid concentrations in the picomolar range. Thanks to this technology transfer, researchers can rely on the same analytical precision and reliability that supported the clinical studies establishing penKid as a valuable kidney function biomarker. The assay’s robust design and German manufacturing ensure durable consistency and reproducibility. With this research-use ELISA, SphingoTec responds to the increasing availability of non-validated assays and encourages researchers to not compromise assay quality and performance to ensure trustworthy results - since data from non-validated tests may reflect assay limitations rather than the true performance of the penKid biomarker. Complementary approaches for clinical use and scientific exploration SphingoTec pursues its commercial strategy for the biomarker penKid through strategic out-licensing partnerships such as Boditech Med, which has developed an IVDR-certified assay for routine clinical use and rapid diagnostics. The newly launched ELISA sphingotest® penKid® represents a complementary initiative, specifically designed to support high-throughput clinical and translational research. Through this dual approach, SphingoTec reaffirms its commitment to fostering scientific collaboration and promoting the broader exploration of penKid across diverse research settings. “Developing the ELISA sphingotest® penKid® reflects our long-term commitment to improving critical care diagnostics,” said Deborah Bergmann, Managing Director and CEO of SphingoTec GmbH. “Beyond its currently validated clinical applications, we see strong potential for penKid to support research and improve diagnostics in other fields where kidney function is relevant. By encouraging scientists worldwide to incorporate penKid into their studies and clinical programs, we aim to accelerate innovation and advance best-fit diagnostic solutions that ultimately improve patient care.” About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a biomarker company focusing on the out-licensing of innovative critical care solutions for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec develops its biomarkers to the commercial stage and partners with IVD companies to make them available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany
• PenKid surpasses serum creatinine on Day 1 post-transplant in detecting delayed graft function (DGF), with an AUROC of 0.87 versus 0.56 for creatinine. • PenKid differentiates slow graft function (SGF) from DGF up to 8 days earlier than current methods, supporting more timely clinical decisions. • PenKid levels remain unaffected by kidney replacement therapy (KRT), allowing for more accurate assessment of kidney function. • Independent validation in transplant cohort from Australia confirms performance and broad applicability. Hennigsdorf/Berlin, Germany, July 1, 2025 - Diagnostic company SphingoTec GmbH (“SphingoTec”) announces a landmark study (1) published in Transplant International, led by Heidelberg University Hospital in Germany in collaboration with researchers from Sydney, Australia, which identifies Proenkephalin A 119-159 (penKid) as a reliable biomarker for early and precise assessment of graft function trajectories following kidney transplantation. The research demonstrates that PenKid not only identifies patients at risk for DGF significantly earlier than traditional markers but also distinguishes between slow and delayed graft function with remarkable accuracy, offering clinicians a valuable new tool for patient management. The study prospectively evaluated 159 consecutive kidney transplant recipients at Heidelberg University Hospital and validated findings in an independent cohort from Sydney. PenKid consistently outperformed serum creatinine (SCr) in predicting graft function trajectories, particularly in the critical early post-transplant period. Notably, PenKid’s ability to remain unaffected by KRT—a treatment for severe kidney dysfunction—further sets it apart from SCr, which can be influenced by non-renal factors and KRT itself, thereby enhancing the reliability of graft function assessment. Multivariate analysis confirmed PenKid as the strongest independent predictor of both short-term graft function and 30-day outcomes, underscoring its clinical utility for early risk stratification. The biomarker’s superior granularity allows for nuanced classification of DGF severity, supporting more informed decisions regarding the initiation of dialysis or biopsy and offering potential for individualized patient care. With these findings, penKid steps forward as a practical addition to the transplant clinician’s toolkit, promising to sharpen decision-making for optimal outcomes. Its adoption could help transplant teams act with greater confidence and precision, ultimately strengthening the standard of care in kidney transplantation. ## References 1. Benning L et al. (2025) Proenkephalin A 119-159 in Kidney Transplantation: A Novel Biomarker for Superior Tracking of Graft Function Trajectories. Transpl. Int. 38:14366. doi: 10.3389/ti.2025.14366 About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a biomarker company focusing on the out-licensing of innovative critical care solutions for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec develops its biomarkers to the commercial stage and partners with IVD companies to make them available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, commercially available on diagnostic platforms AFIAS and Nexus IB10 and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com Contact : Ruxandra Lenz Marketing and Communication SphingoTec GmbH Phone +49-3302-20565-0 Email: press@sphingotec.com