Science
Advantages
For Pathologists:
Digital multi-channel visualization of morphology and staining on one slide.
For Lab Directors:
Standardized workflows, reproducible processes and same-day turnaround.
For Regulatory Officers:
IVDR CE-marked and FDA-registered hardware/software, SaMD CE-marked, ready for EU AI Act. [4]
A NEW STANDARD
X-ZELL Next-Generation Cytology (NGC) is the first digitally integrated immunostaining solution designed specifically for cytology specimens.
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Standardized, reproducible workflow [8]
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Minimal sample material required (from 2 mL) [2]
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IVDR CE-marked and FDA-registered instruments, software & consumables [3, 4]
BUILT FOR CYTOLOGY
NGC is the world’s first dedicated digital cytology platform technology, specifically developed to handle the unique challenges of cytology samples.
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Temperature-controlled Cryofixation™
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Eight-channel Cryoimmunostaining™ on a single slide
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High-speed digitization & rapid on-screen visualization
READY-TO-USE
Benefit from extensive usability testing across multiple cytopathology laboratories around the globe.
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Plug-and-play workflow for same-day integration
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Standardized sample preparation for reproducibility
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Ready-to-use Cryophore™ panels
ROUTINE-PROVEN
Validated across multiple usability studies, the NGC workflow has demonstrated consistent performance, with < 2% technical failure rate reported in usability studies. [2]
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Consistent performance from cytology samples. [2]
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Same-day turnaround compared to multi-day cellblock processing [2]
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Multiplexing delivers multiple antibody signals from a single slide [2]
REGULATORY-FIRST
NGC was developed with regulatory compliance as a core design principle, supporting transparency and accountability in laboratory workflows. [4]
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End-to-end solution from sample to screen, no black box
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Developed in accordance with IVDR quality system requirements
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SaMD-CE certified for interpretable, human-in-the-loop data
DIGITAL-READY
The NGC platform was designed from the ground up to support modern, digital-ready laboratories.
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Fully digital format for downstream analysis
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Human-in-the-loop workflow design
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Software designed with AI compatibility in mind
Check full reference list under Resources
