Deep genomic analysis of solid tumours

celldx is a tissue based comprehensive molecular profiling of solid tumours with the aim to personalise therapy options. celldx also provides information on the benefit of immune checkpoint inhibitors.

About celldx

Comprehensive genomic profiling of tumour tissue has become an established component of precision oncology, providing valuable molecular information to support the clinical management of patients with solid tumours.

celldx is a comprehensive genomic profiling (CGP) test designed for patients diagnosed with solid tumours. Using next-generation sequencing (NGS), celldx analyses tumour DNA and RNA to identify clinically relevant genomic alterations in a single test.

The assay detects genomic alterations that may be associated with targeted therapeutic options according to recognised clinical guidelines. In addition, PD-L1 expression is evaluated by immunohistochemistry (IHC), together with tumour mutational burden (TMB), mismatch repair (MMR) status, and, where clinically indicated, microsatellite instability (MSI), providing comprehensive molecular information to support clinical decision-making.

celldx provides advantages whenever ...

... there has to be a fast decision about a targeted therapy.

... an immunotherapy is an option for the patient.

SNVs | InDels
392 Genes

SNV = Single nucleotid variation; InDel = Insertion / Deletion

CNAs
333 Genes

CNA = Copy number alteration

Fusions
51 Genes

TMB | PD-L1

511 Genes

MMR

MMR = Mismatch repair

Comprehensive celldx

Examples of Clinically Relevant Biomarkers and Associated Therapeutic Options

celldx evaluates clinically relevant genomic biomarkers that are recognised in current oncology practice. The biomarkers listed below are examples of genomic alterations that may be associated with therapeutic options according to recognised clinical guidelines and applicable regulatory approvals.

The information below is provided for illustrative purposes only. Treatment decisions remain the responsibility of the treating physician and should be based on the patient's overall clinical condition, pathological findings, recognised clinical guidelines, and local prescribing information. celldx does not recommend, prescribe, or prioritise any specific medicinal product.

Indications
Representative Biomarkers Evaluated by Celldx™
Examples of Associated Therapeutic Options*
  • Indications

    Non-Small Cell Lung Cancer (NSCLC)

    Representative Biomarkers Evaluated by Celldx™

    EGFR exon 19 deletion, EGFR exon 21 L858R, EGFR exon 20 insertion, EGFR T790M, KRAS G12C, ALK rearrangements, BRAF V600E, ROS1 rearrangements, RET rearrangements, MET exon 14 skipping alterations, NTRK1/2/3 fusions, PD-L1

    Examples of Associated Therapeutic Options*

    EGFR inhibitors, KRAS inhibitors, ALK inhibitors, BRAF/MEK inhibitors, ROS1 inhibitors, RET inhibitors, MET inhibitors, TRK inhibitors, immune checkpoint inhibitors†

  • Indications

    Colorectal Cancer (CRC)

    Representative Biomarkers Evaluated by Celldx™

    KRAS wild-type, BRAF V600E, Mismatch Repair Deficiency (dMMR)

    Examples of Associated Therapeutic Options*

    EGFR inhibitors, BRAF inhibitors, immune checkpoint inhibitors†

  • Indications

    Breast Cancer

    Representative Biomarkers Evaluated by Celldx™

    ERBB2 (HER2) amplification, BRCA1/2 alterations, PIK3CA alterations

    Examples of Associated Therapeutic Options*

    HER2-targeted therapies, PARP inhibitors, PI3K inhibitors

  • Indications

    Ovarian Cancer

    Representative Biomarkers Evaluated by Celldx™

    BRCA1/2 alterations, Homologous Recombination Repair (HRR) deficiency

    Examples of Associated Therapeutic Options*

    PARP inhibitors

  • Indications

    Melanoma

    Representative Biomarkers Evaluated by Celldx™

    BRAF V600E/V600K

    Examples of Associated Therapeutic Options*

    BRAF inhibitors, MEK inhibitors

  • Indications

    Urothelial Carcinoma

    Representative Biomarkers Evaluated by Celldx™

    FGFR2/FGFR3 alterations, PD-L1

    Examples of Associated Therapeutic Options*

    FGFR inhibitors, immune checkpoint inhibitors†

  • Indications

    Prostate Cancer

    Representative Biomarkers Evaluated by Celldx™

    BRCA1/2 alterations, HRR deficiency

    Examples of Associated Therapeutic Options*

    PARP inhibitors

  • Indications

    Solid Tumours

    Representative Biomarkers Evaluated by Celldx™

    NTRK1/2/3 fusions, dMMR/MSI-H

    Examples of Associated Therapeutic Options*

    TRK inhibitors, immune checkpoint inhibitors†

Important Information

* The therapies listed represent examples of therapeutic classes that may be associated with the corresponding biomarkers according to recognised clinical guidelines and applicable regulatory approvals. Availability and approved indications vary between countries and may change over time.

† The use of immune checkpoint inhibitors is determined by multiple clinical factors and should not be based solely on a single biomarker result.

celldx is not a companion diagnostic (CDx). The assay provides comprehensive molecular information intended to support licensed healthcare professionals in clinical management decisions. Results should always be interpreted together with the patient's clinical history, pathological findings, and recognised oncology guidelines.

FAQ

How long does it take to receive the results and how will they be provided?

The turnaround time, after which the patient or his treating doctor will receive the results, is usually 8 days from the day the laboratory receives the tissue sample.
The test report include all genomic and histological characteristics and are provided electronically and password-protected.

Which analytes are included?

SNVs, InDels, CNAs, Fusions, TMB, PD-L1, MMR, HRD-relevant genes (Homologous recombination deficiency).

Is celldx a companion diagnostic (CDx)?

No. celldx is not a companion diagnostic (CDx).

celldx is a comprehensive genomic profiling (CGP) test that provides molecular information on clinically relevant genomic alterations in solid tumours. The results are intended to support licensed healthcare professionals in molecular characterisation and clinical management decisions in conjunction with recognised clinical guidelines, the patient's clinical condition, and other diagnostic findings.

Is celldx of advantage when assessing immunotherapy options?

Yes. celldx evaluates biomarkers that may be relevant to immunotherapy assessment, including tumour mutational burden (TMB) by NGS, PD-L1 expression and mismatch repair (MMR) protein
status by immunohistochemistry (IHC), and microsatellite instability (MSI), where clinically indicated.
These results provide molecular information to support healthcare professionals in clinical management decisions in accordance with recognised clinical guidelines.