idw – Informationsdienst Wissenschaft
Nachrichten, Termine, Experten
Nachrichten, Termine, Experten
idw - Informationsdienst
Wissenschaft
Nuremberg — Scientists at Nuremberg Hospital and Paracelsus Medical University have succeeded in developing the world’s first monoclonal antibody that specifically and sensitively detects vasoinhibin — also known as 16-kDa prolactin (16K PRL). The international patent application PCT/EP2024/073698, published under the number WO2025098661A1, protects the antibody itself as well as its specific use in standardized diagnostic test systems, including a novel ELISA kit. The patent application also paves the way for the establishment of an international reference laboratory for vasoinhibin measurement.
Vasoinhibin is formed by proteolytic cleavage of the pituitary hormone prolactin and comprises its N-terminal fragment, which is 16 kilodaltons in size. The protein possesses pronounced anti-angiogenic properties: it inhibits the formation of new blood vessels, regulates vascular permeability, and modulates endothelial function. Vasoinhibin is thought to play a pathogenic role in several serious diseases, including peripartum cardiomyopathy, preeclampsia, and retinal diseases such as diabetic retinopathy and macular edema.
Peripartum cardiomyopathy: An unmet diagnostic need
Peripartum cardiomyopathy (PPCM) is a rare but life-threatening form of heart failure in young women that occurs shortly before or after childbirth. Elevated vasoinhibin levels in the blood may play a causal role in the microvascular damage to the heart that underlies the disease. The significance of vasoinhibin as a diagnostic and prognostic biomarker is currently being evaluated in international clinical trials. To date, no standardized, commercially available quantitative test for vasoinhibin is available—a gap that this development aims to fill.
Antibody Development and Commercialization
The monoclonal antibody was generated using hybridoma technology and fully sequenced. A particular technical challenge was the specific recognition of vasoinhibin as distinct from full-length prolactin, since vasoinhibin is merely an N-terminal fragment of prolactin and both proteins have a largely identical amino acid sequence. The production and commercial distribution of the antibody for the international market (Research Use Only) is carried out in cooperation with Davids Biotechnologie GmbH, Regensburg.
ELISA Kit and International Reference Laboratory: The Next Steps
Based on the patented monoclonal antibody, a complete ELISA kit for the quantitative determination of vasoinhibin in human serum is currently being developed. In addition to the monoclonal capture antibody, the kit will include a specific polyclonal detector antibody as well as standards based on recombinant vasoinhibin. The initial goal is a standardized, reproducible measurement system that meets the requirements of clinical studies (Research Use Only) and, in the long term, clinical diagnostics (regulatory approval).
In addition, the establishment of an international reference laboratory for vasoinhibin measurement is planned. Such a reference laboratory is intended to serve as a quality assurance authority for clinical and scientific laboratories worldwide, provide reference materials, and contribute to the establishment of internationally recognized reference ranges and clinical cutoff values for vasoinhibin. The institutional affiliation and operation of the reference laboratory are the subject of ongoing strategic planning. International patent protection for the monoclonal antibody forms an essential foundation for this: it ensures the laboratory’s methodological independence, guarantees defined quality standards, and creates the conditions for sustainable international networking.
“Vasoinhibin is a clinically significant biomarker whose diagnostic potential in peripartum cardiomyopathy and other vasoinhibin-associated diseases has so far remained untapped—not least because a standardized measurement method was lacking. With the patented antibody, the ELISA kit currently in development, and the planned reference laboratory, we are establishing the measurement infrastructure necessary for the clinical application of this biomarker.”
— Prof. Jakob Triebel, MD, Nuremberg Hospital
About the Institute
The Institute for Laboratory and Infectious Diseases Medicine at Nuremberg Hospital, headed by Professor Jörg Steinmann, MD, is a university institute of Paracelsus Medical University Nuremberg (PMU). It combines clinical diagnostics with translational research in the fields of microbiology and laboratory medicine. Research focuses include the role of the prolactin/vasoinhibin axis in vascular and cardiovascular diseases.
Prof. Jakob Triebel, MD
Institute for Laboratory and Infectious Diseases Medicine
Nuremberg Hospital | Paracelsus Medical University
Prof.-Ernst-Nathan-Str. 1, 90419 Nuremberg
Phone: +49 911 398-114181
Email: jakob.triebel@klinikum-nuernberg.de
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