Celldx™ is a next-generation sequencing-based in vitro diagnostic test used for comprehensive genomic profiling of solid tumour tissue.
The test analyses tumour DNA and RNA to identify clinically relevant genomic alterations associated with recognised oncology guidelines. The results provide molecular information that may assist healthcare professionals in clinical management decisions together with the patient’s clinical condition, pathology findings and other diagnostic information.
Celldx™ simultaneously evaluates multiple biomarker types, including Single Nucleotide Variants (SNVs), Insertions and Deletions (InDels), Copy Number Alterations (CNAs), gene fusions/rearrangements, Tumour Mutational Burden (TMB), Microsatellite Instability (MSI), PD-L1 expression by immunohistochemistry, and Mismatch Repair (MMR) protein status by immunohistochemistry, where applicable.
Celldx™ may be considered when a treating healthcare professional requires molecular profiling of a solid tumour to support clinical management in accordance with recognised oncology guidelines.
Celldx™ does not recommend, prescribe, or prioritise any specific medicinal product and is not intended to be used as the sole basis for diagnosis or treatment selection.
Final treatment decisions remain the responsibility of the treating healthcare professional.