ATHLONE, IRELAND – Diagnostic Green Ltd (Diagnostic Green) is pleased to announce that Verdye (Indocyanine Green, ICG) has received regulatory approval in Germany for intraoperative identification of sentinel lymph nodes in breast cancer.
This marks a major advancement for the German market, as Verdye’s approval follows successful regulatory clearance earlier this year in 18 other territories across Europe and the UK. With this latest milestone, breast cancer surgeons in Germany can now adopt ICG fluorescence imaging as a non-radioactive, safe and efficient alternative to traditional methods.
Sentinel lymph node biopsy (SLNB) remains central to the surgical management of early- stage breast cancer, serving as a key method for assessing lymphatic spread—one of the most important prognostic indicators of disease progression. In line with this, the AGO (Arbeitsgemeinschaft Gynäkologische Onkologie) guidelines in Germany emphasise the importance of intraoperative assessment of sentinel lymph nodes, which can help avoid complete axillary lymph node dissection—a procedure associated with increased risk of complications such as lymphoedema, nerve injury, and limited shoulder mobility.
Until now, SLNB in Germany has often relied on Technetium-99m (99mTc) radio-labelled colloids, blue dyes (BD) with some evidence of Superparamagnetic iron oxide tracers also in use. These methods, while established, carry significant limitations:
- 99mTc use requires pre-procedure coordination, exposes staff to ionising radiation, and necessitates compliance with stringent radiopharmaceutical protocols.
- Blue dyes can cause adverse effects such as soft tissue necrosis and haematological complications, which limits their routine use.
- SPIO (superparamagnetic iron oxide) tracers, while emerging as an alternative, can present challenges including skin staining, interference with post-operative imaging (MRI artefacts), and limited intraoperative visual feedback, making real-time guidance during surgery more difficult.
Verdye enables real-time, high-contrast visualisation of sentinel lymph nodes without radioactive materials or dyes with local and systemic risks —providing a modern, low-risk and streamlined solution that improves surgical workflow.
“This approval represents a significant step forward for breast cancer surgery in Germany,” said Declan Cassells, Managing Director of Diagnostic Green. “Following approvals across 18 DG-MKT-2026-003 other European territories, we are proud to expand access to a non-radioactive, safe and more accessible option for SLNB procedures.”
The approval was underpinned by robust clinical evidence, including multiple meta-analyses that concluded:
- ICG fluorescence (ICG-F) has been shown to be superior to blue dye in all relevant metrics for breast SLN detection
- ICG-F is non-inferior to radioisotope (RI) techniques and RI + BD combinations in both per-case and per-node sensitivity and false negative rates
- ICG-F has been shown to be at least non-inferior, if not superior, to RI and RI +BD in per-node SLN detection
VerdyeTM is now available throughout the EMEA region via a network of authorised distributors or directly from Diagnostic Green.
To order or learn more, please visit: https://diagnosticgreen.com/row/distributor-details/ Or contact us at: info@diagnosticgreen.com