Researchers Link Low Levels of Pro-Enkephalin to Future Breast Cancer in Healthy Women
sphingotec announces the publication of trial results showing the strong association between low pro-enkephalin (pro-ENK) levels in plasma and incident breast cancer
Cambridge, Mass. – July 15, 2015
– sphingotec LLC announced today that the results of two studies examining the association between proenkephalin (pro-ENK) and incident breast cancer were published online in the Journal of Clinical Oncology. The studies, which were conducted by researchers at Skåne University Hospital in Malmö, Sweden and together encompass almost 3,500 subjects, demonstrated a strong association between low plasma concentration of the opioid precursor peptide pro-ENK and increased breast cancer risk in middle-aged and post-menopausal women independent from other possible risk factors.
Although experimental studies have established that enkephalins and related opioid hormones can inhibit the growth of cancer cells, these are the first studies to investigate whether plasma concentration of pro-ENK can predict near-term breast cancer risk in healthy women. The strong association between concentrations of pro-ENK and incident breast cancer found during these studies indicates that pro-ENK is a viable tool for predicting breast cancer risk.
The results represent a potential breakthrough in helping women without a known family history of breast cancer understand their own risk. Current tools such as the GAIL risk score are helpful, but the parameters included in the score are non-modifiable, have only weak prognostic power and do not address an individual’s risk. And while mammography is effective at detecting early stage breast cancer, there is ongoing concern about over-diagnosis and missed cases. There is a great need for biomarkers that can identify women at highest risk so that appropriate interventional measures can be taken to prevent clinical manifestation of life-threatening breast cancer.
“Our goal is to prevent deaths related to breast cancer,” said Dr. Andreas Bergmann, founder and CEO for sphingotec. “We have now identified two promising biomarkers to achieve this goal: proneurotensin* (pro-NT) and proenkephalin, which have been demonstrated now in two independent cohorts to predict risk in healthy women. The results of these studies imply great promise for the future of breast cancer prevention. We believe these findings will aid in helping women better understand their breast cancer risk so they can take the appropriate measures for preventing this devastating disease.”
To conduct the first study, Melander et al. measured pro-ENK in fasting plasma from 1,929 healthy women with a mean age of 59 years old participating in the Malmö Diet and Cancer Study (MDCS) and used Cox proportional hazards models to relate pro-ENK to incidence of breast cancer during 15 years of follow up. In the second study, using a case-control design, they sampled 1,569 women from the Malmö Preventive Project with a mean age of 70 years old and used multivariate adjusted logistic regression models to relate pro-ENK and to risk of breast cancer during the observation period.
Results of this study appear online in the Journal of Clinical Oncology.
*Melander et al. JAMA. 2012;308(14):1469-1475
Authors: Olle Melander, Marju Melander, Jonas Manjer, Peter Almgren, Peter Nilsson, Gunnar Engström, Bo Hedblad, Signe Borquist, Ute Kilger, Jennifer Suhr, Oliver Hartmann, Joachim Struck, Andreas Bergmann and Mattias Belting
• 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