About Celldx^™

Celldx^™ is a next-generation sequencing-based in vitro diagnostic medical device intended for the qualitative detection of validated single-nucleotide variants, insertions and deletions, copy-number alterations and gene fusions, Mismatch Repair, and for reporting qualitative tumour mutational burden status using FFPE tumour tissue.

Comprehensive Biomarker Coverage

• 511 genes assessed across the panel.
• Single Nucleotide Variants and InDels across 392 genes.
• Copy Number Alterations across 333 genes.
• Gene fusions, Mismatch Repair and qualitative Tumour Mutational Burden status.
• PD-L1 evaluation.

Clinical Use

Celldx^™ detects and reports validated genomic alterations to support the molecular characterisation of solid tumours and the evaluation of molecular biomarker indications for targeted therapy selection, as recommended by current NCCN Clinical Practice Guidelines.

Results are intended for interpretation by qualified healthcare professionals alongside the patient’s clinical condition and other diagnostic information.

Sample and Reporting

• FFPE solid tumour tissue is required.
• Tumour content in the provided tissue should be at least 25%.
• Median depth of coverage is at least 1000x.
• Turnaround time is 6–8 days from receipt of the sample.
• Validated genomic findings are presented in a simplified report for healthcare-professional review.