X-ZELL Cryophore™ Panels achieve IVDR CE Mark
Singapore, April 2026 – X-ZELL is proud to announce that its new Cryophore™ multiplex antibody panels have achieved IVDR CE marking, representing an important milestone in bringing multiplex immunostaining into routine cytology.
First announced in 2025, the new Cryophore™ product line translates X-ZELL’s proprietary Cryoimmunostaining™ workflow into a structured panel format designed for standardized laboratory workflows.
Addressing the long-standing challenge of tissue exhaustion in minimally invasive diagnostics, Cryoimmunostaining™ enables the simultaneous visualization of multiple immunomarkers on a single microscope slide while preserving cellular morphology and supporting standardized staining conditions.
“With the transition to IVDR CE-marked Cryophore™ panels, we are taking an important step toward broader clinical adoption of multiplex immunostaining in cytology in Europe,” commented X-ZELL Founder, Dr. Sebastian Bhakdi.
“To our knowledge, these are the first IVDR CE-marked multiplex antibody panels specifically designed for cytology. Following extensive development and validation, we are pleased to bring standardized multiplex panel formats into regulated laboratory workflows.”
The initial IVDR Cryophore™ release includes three multiplex panels for effusion cytology that have been developed in consultation with an international expert consortium of cytopathology thought leaders from Europe and the United States. Each panel combines seven fluorophore-labelled antibodies plus a nuclear counterstain within a single workflow.
PLEURAL FLUID 1 (PF1)
Including GATA3, Calretinin, TTF1, EpCAM, CD45, p40, Synaptophysin – a multiplex marker constellation targeting antigens commonly associated with lung adenocarcinoma, small cell and squamous cell carcinoma, as well as breast and urothelial carcinoma cells encountered in pleural effusions.
PLEURAL FLUID 3 (PF3)
Including NKX3.1, Calretinin, TTF1, EpCAM, CD45, p40, Synaptophysin – a variant of PF1 incorporating NKX3.1, a marker frequently referenced in the evaluation of prostate-derived carcinoma cells.
ASCITIC FLUID (AF)
Including PAX8, SATB2, CK19, EpCAM, CD45, Calretinin, CK7 – a multiplex marker constellation targeting antigens commonly associated with gynaecological, colorectal and other gastrointestinal malignancies encountered in ascitic fluid specimens.
The panels are now available as IVDR CE-marked IVD products in the European Union. Additional panel configurations and clinical validation activities are ongoing.
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About X-ZELL
X-ZELL is an award-winning medical technology company pioneering the field of next-generation cytology. The company’s mission is to transform cancer diagnostics by fusing novel laboratory technology with digital imaging to detect and visualise individual atypical cells in minimally invasive body liquids and digitize them for instant on-screen analysis. Founded by Y Combinator finalist, Dr Sebastian C.P. Bhakdi, X-ZELL was ranked second-most innovative healthcare start-up in the world in 2020 and has since won the coveted MedTech Innovator APAC competition as well as the Abstract Award at the 2021 European Conference of Cytology.
