Deep genomic analysis of solid tumours

celldx is a tissue based comprehensive molecular profiling of solid tumours with the aim to personalise therapy options. The results are generally available within 8 working days and, in addition to the genetic analysis, also provide information on the benefit of immune checkpoint inhibitors.

About celldx

To individualise the cancer treatment, celldx detects genetic alterations suited for the application of targeted therapies. In addition, immunostaining is performed on the provided tissue samples for PD-L1 suitability in combination with tumour mutational burden and MSI|MMR.

celldx provides advantages whenever ...

<p>... there has to be a fast decision about a targeted therapy.</p>

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

<p>... an immunotherapy is an option for the patient.</p>

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

celldx provides deep molecular analysis for patients with advanced cancers.

SNVs | INDELs
442 Genes
SNV = Single nucleotid variation
INDEL = Insertion / Deletion

CNAs
417 Genes
CNA = Copy number alteration

FUSIONs
51 Genes

TMB

PD-L1

MSI | MMR
MSI = Micro satellite instability
MMR = Mismatch repair

Comprehensive celldx

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

    Non-Small Cell Lung Cancer (NSCLC)

    Biomarker

    EGFR Exon 19 deletions
    EGFR Exon 21 L858R alterations
    T790M
    ALK rearrangements
    BRAF V600E
    ROS1 rearrangements
    MET exon 14 skipping mutation/ MET gene amplification
    NTRK fusions
    PD-L1

    US FDA-approved Therapy

    Afatinib, Gefitinib, Osimertinib
    Erlotinib, Dacomitinib
    Osimertinib
    Alectinib, Crizotinib, Ceritinib, Lorlatinib, Brigatinib
    Dabrafenib in combination with Trametinib
    Entrectinib, Crizotinib, Larlatinib, Ceritinib
    Crizotinib
    Larotrectinib, Entrectinib
    Pembrolizumab, Nivolumab

  • Indications

    Colorectal Cancer (CRC)

    Biomarker

    KRAS wild-type (absence of mutations in exons 2, 3 and 4)
    KRAS wild-type (absence of mutations in exons 2, 3 and 4) and NRAS wild-type (absence in mutations in exons 2, 3 and 4)
    MSI-H/dMMR

    US FDA-approved Therapy

    Cetuximab
    Panitumumab
    Nivolumab ± Ipilimumab or Pembrolizumab

  • Indications

    Breast Cancer

    Biomarker

    ERBB2 (HER2) amplification
    PD-L1
    BRCA1/2 alterations
    PIK3CA

    US FDA-approved Therapy

    Lapatinib, Neratinib, Trastuzumab, Ado-trastuzumab, Emtansine or Pertuzumab
    Atezolizumab
    Olaparib, Talazoparib
    Alpelisib

  • Indications

    Ovarian Cancer

    Biomarker

    BRCA1/2 alterations

    US FDA-approved Therapy

    Olaparib, Rucaparib

  • Indications

    Melanoma

    Biomarker

    BRAF V600E
    BRAF V600E or V600K

    US FDA-approved Therapy

    Dabrafenib or Vemurafenib
    Trametinib or Cobimetinib in combination with Vemurafenib

  • Indications

    Solid Tumours

    Biomarker

    NTRK
    MSI-H/dMMR

    US FDA-approved Therapy

    Entrectinib, Larotrectinib
    Pembrolizumab

  • Indications

    Urothelial Carcinoma

    Biomarker

    FGFR2, FGFR3 gene alterations
    PD-L1

    US FDA-approved Therapy

    Erdafitinib
    Pembrolizumab

  • Indications

    Prostate Cancer

    Biomarker

    AR

    US FDA-approved Therapy
  • Indications

    Other cancers

    Biomarker

    ERBB2 (HER2), BRCA1, BRCA2, PIK3CA, NTRK1, NTRK2 and NTRK3

    US FDA-approved Therapy

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 working days from the day the laboratory receives the tissue sample. The test report contains all genomic highlights and lists the particular therapy options.

Which analytes are included?

SNVs, INDELs, CNAs, Fusions, TMB, PD-L1, MSI, MMR, HRD (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 microsatellite instability (MSI), tumor mutational burden (TMB) and PD-L1 status via immunostaining.

Contact

Dr. Stefan Schuster,<p>Managing Director Europe</p>

Dr. Stefan Schuster

Managing Director Europe