CellDx™ - Advanced Tumor Profiling for Personalized Targeted Anti-cancer Treatments

The evaluation of tumor tissue serves the dual purpose of establishing a diagnosis and determining the status of therapeutically relevant biomarkers, such as gene variants and protein expression. These biomarkers play a crucial role in guiding the selection of targeted anti-cancer agents. However, traditional molecular profiling assessments have limitations in terms of their coverage of genetic variants, often requiring individual tests for each biomarker.

 
Advanced and comprehensive molecular profiling of tumors provides deeper analysis into the molecular and functional dynamics of the tumor, revealing insights that conventional assessments may miss. A comprehensive molecular profiling test can identify multiple tumor vulnerabilities as well as resistance mechanisms in a single step.


The wealth of information obtained through this approach empowers treating physicians to make well-informed decisions regarding the most suitable and effective treatment strategies. This not only reduces the risk of treatment failure but also minimizes the potential for toxicities associated with ineffective treatments.

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About CellDx™

CellDx™ is an intensive and in-depth tumor molecular profiling. It analyses millions of data points at the molecular level to reveal threats and vulnerabilities which enable optimal identification of targets for precision treatment selection.

How does
CellDx™ work?

CellDx™ is an intensive and in-depth tumor molecular profiling. It analyses millions of data points at the molecular level to reveal threats and vulnerabilities which enable optimal identification of targets for precision treatment selection. CellDx™ evaluates: Gene variants such as point mutations (SNV, Single-Nucleotide Variants), Insertions and Deletions, Translocations, Rearrangements and Fusions, Tumor Mutation Burden, Microsatellite instability, PDL1 status CellDx™ is agnostic to classical determinants such as primary organ, histological subtype, morphology (grade), aggressiveness and extent of disease.

CellDx-How

Reliable Technology

CellDx™ is based upon the assessment of the core elements and features that sustain and drive the malignancy, i.e., the molecular perturbations and their dynamics. CellDx™’s comprehensive and meticulous assessment of the molecular tumor interactome is designed to provide relevant insight and identifies aspects that have to be addressed while designing patient-specific treatment strategies. This is essential to design more effective treatments with lower risk of failures and toxicities.

Clinical Performance

The clinical utility of CellDx™ for informing selection of patient-specific, safe and efficacious anti-cancer treatment regimens has been demonstrated in several clinical studies and case reports.

CellDx™ is validated stringently to meet global standards.

Comprehensive celldx

Biomarker Based Drug Indications (Examples)

Indications

Biomarker

US FDA-approved Therapy

Non-Small Cell Lung Cancer (NSCLC)

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

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

Colorectal Cancer (CRC)

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)
dMMR

Cetuximab
Panitumumab
Nivolumab ± Ipilimumab or Pembrolizumab

Breast Cancer

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

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

Ovarian Cancer

BRCA1/2 alterations

Olaparib, Rucaparib

Melanoma

BRAF V600E
BRAF V600E or V600K

Dabrafenib or Vemurafenib
Trametinib or Cobimetinib in combination with Vemurafenib

Solid Tumours

NTRK
dMMR

Entrectinib, Larotrectinib
Pembrolizumab

Urothelial Carcinoma

FGFR2, FGFR3 gene alterations
PD-L1

Erdafitinib
Pembrolizumab

Prostate Cancer

AR

Other cancers

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

Clinical Performance

The clinical utility of CellDx™ for informing selection of patient-specific, safe and efficacious anti-cancer treatment regimens has been demonstrated in several clinical studies and case reports.

Deep tumor profiling to identify molecular features including gene variants and gene expression to identify patients who may benefit from targeted anti-cancer treatments.

Patients who have been advised molecular tumor profiling for selection of targeted anti-cancer treatments.

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How it Works?

Tumor components including proteins, DNA and RNA are isolated from tumor tissue and blood and used for molecular profiling to identify features associated with response to targeted anti-cancer agents.

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Why should I get Checked?

CellDx™’s deep tumor profiling provides a detailed insight into tumor molecular dynamics which can inform selection of safe and more efficacious treatment regimens.

CellDx™ is available for all solid organ cancers.

CellDx™ can provide therapeutically relevant insight into the tumor, which can assist physicians to make life-saving clinical management decisions more effectively. Download the brochure and sample repost below:

Advantages of CellDx™

  • Includes assessment of all molecular biomarkers indicated in the NCCN guidelines.
  • Evaluates additional clinically relevant biomarkers.
  • Guides treatment selection in labeled as well as label-agnostic settings.

Sample Requirements

CellDx™ requires FFPE tumor block(s) OR Tumor Tissue in Preservative Solution and Formalin Solution.

Resources
Important Publications

Encyclopedic Tumor Analysis for Guiding Treatment of Advanced, Broadly Refractory Cancers: Results from The RESILIENT Trial

VIEW PDF       VISIT SITE   

Author: Nagarkar R
Datar Cancer Genetics
Published Date: Sept 24, 2019

Improved Treatment Outcomes by Using Patient Specific Drug Combinations in Mammalian Target of Rapamycin Activated Advanced Metastatic Cancers

VIEW PDF       VISIT SITE   

Author: Crook T
Datar Cancer Genetics
Published Date: Apr 16, 2021

Angiogenesis Inhibitors in Personalized Combination Regimens for the Treatment of Advanced Refractory Cancers.

VIEW PDF       VISIT SITE   

Author: Crook T
Datar Cancer Genetics
Published Date: Sept 20, 2021

Clinical Utility of Circulating Tumor-Associated Cells to Predict and Monitor Chemo-Response in Solid Tumors

VIEW PDF       VISIT SITE   

Author: Crook T
Datar Cancer Genetics
Published Date: Nov 10, 2020

FAQ

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.

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

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.

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

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