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2 clinical sites
Halle and Frankfurt, Germany.
Prospective multi-site IVDR clinical validation of Cryophore™ antibody panels XZ3001, XZ3003, and XZ3004.
Validation at Krankenhaus St. Elisabeth und St. Barbara Halle and Krankenhaus Nordwest Frankfurt, January-March 2026.
Halle and Frankfurt, Germany.
All twelve antibodies in the Cryophore panel set reported concordant.
Submitted slides before QC exclusions and OOE resolution.
QC-passed slides after OOE resolution, with no unresolved discordance.
Full documentation should be requested for procurement, clinical, or regulatory review.
100% concordance for the highest-pair-count markers, including two-site passes for CK7, CK19, and SATB2.
Markers supporting tumour-origin and lineage interpretation are reported as pass, with NKX3.1 and PAX8 noted as conditional/risk-based passes.
Calretinin is described as an Option B internal positive control marker.
The deck distinguishes IVDR CE-marked instruments and Cryophore™ panels from RUO reagent and service offerings. It also explicitly says not to describe FDA registration/listing as FDA approval or FDA clearance.
For current market availability, intended-use wording, and documentation, qualified institutions should request the current evidence dossier.
Use the evidence page to see what is available, or contact X-ZELL for current documentation under the appropriate commercial process.
Evidence note: Clinical performance must be established in the intended patient-specimen context. Product availability, regulatory status, and intended use may vary by market. Please contact X-ZELL for current documentation.