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

Tissue based examinations of the molecular genetic properties of a tumour are currently the gold standard in cancer therapy.

celldx is a detailed molecular analysis for patients with advanced cancer.

To individualise the cancer treatment, celldx detects genetic alterations suited for the application of targeted therapies. Simultaneously, immunostaining is performed on the provided tissue samples for PD-L1 suitability in combination with tumour mutational burden and MMR, and, if necessary, MSI (Microsatellite instability).

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

Biomarker Based Drug Indications (Examples)
Indications
Biomarker
US FDA-approved Therapy
  • Indications

    Non-Small Cell Lung Cancer (NSCLC)

    Biomarker
    1. EGFR exon 19 deletions/ exon 21 L858R
    2. EGFR exon 20 insertion
    3. EGFR T790M
    4. KRAS G12C
    5. ALK rearrangements
    6. BRAF V600E
    7. ROS1 rearrangements
    8. RET rearrangements
    9. MET exon 14 skipping alterations
    10. NTRK 1/2/3 fusions
    11. PD-L1
    US FDA-approved Therapy
    1. Gefitinib, Erlotinib, Afatinib, Dacomitinib, Osimertinib
    2. Amivantamab, Mobocertinib
    3. Osimertinib
    4. Sotorasib
    5. Alectinib, Crizotinib, Ceritinib, Lorlatinib, Brigatinib
    6. Dabrafenib in combination with Trametinib
    7. Entrectinib, Crizotinib
    8. Selpercatinib, Pralsetinib
    9. Capmatinib, Tepotinib
    10. Larotrectinib, Entrectinib
    11. Pembrolizumab, Nivolumab, Atezolizumab
  • Indications

    Colorectal Cancer (CRC)

    Biomarker
    1. KRAS wild-type
    2. dMMR
    3. BRAF V600E
    US FDA-approved Therapy
    1. Cetuximab, Panitumumab
    2. Nivolumab ± Ipilimumab or Pembrolizumab
    3. Encorafenib
  • Indications

    Breast Cancer

    Biomarker
    1. ERBB2 (HER2) amplification
    2. BRCA1/2 alterations
    3. PIK3CA
    US FDA-approved Therapy
    1. Lapatinib, Neratinib, Trastuzumab, Ado-Trastuzumab emtansine, Pertuzumab, Margetuximab, Tucatinib, Fam-Trastuzumab deruxtecan
    2. Olaparib, Talazoparib
    3. Alpelisib
  • Indications

    Ovarian Cancer

    Biomarker
    1. BRCA1/2 alterations
    2. HRR deficient tumours
    US FDA-approved Therapy
    1. Olaparib, Rucaparib, Niraparib
    2. Niraparib
  • Indications

    Melanoma

    Biomarker
    1. BRAF V600E
    2. BRAF V600E or V600K
    US FDA-approved Therapy
    1. Dabrafenib or Vemurafenib
    2. Trametinib or Cobimetinib in combination with Dabrafenib or Vemurafenib
  • Indications

    Urothelial Carcinoma

    Biomarker
    1. FGFR2, FGFR3 gene alterations
    2. PD-L1
    US FDA-approved Therapy
    1. Erdafitinib
    2. Pembrolizumab, Atezolizumab
  • Indications

    Prostate Cancer

    Biomarker
    1. HRR deficient tumours, BRCA1/2 mutations
    US FDA-approved Therapy
    1. Olaparib
  • Indications

    Solid Tumours

    Biomarker
    1. NTRK1/2/3 fusions
    2. sMMR
    US FDA-approved Therapy
    1. Entrectinib, Larotrectinib
    2. Pembrolizumab

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 suited as a companion diagnostic tool?

Yes, celldx can provide information if a target alteration is present. Evaluation of therapies in the need of companion diagnostics across several cancer indications is available as well as clinical trial matching across all solid tumors.

Is celldx of advantage when selecting an immunotherapy?

celldx provides informed decisions if an immunotherapy is beneficial using genomic signatures like tumor mutational burden (TMB) and PD-L1 status via immunostaining.