The World's Most Advanced Cancer Profiling for Bespoke Anti-cancer Treatment Strategies

Evaluation of tumor tissue is used for establishing a diagnosis as well as to determine status of therapeutically relevant biomarkers (gene variants, protein expression) which inform selection of targeted anti-cancer agents. However, tissue sample from a foundational biopsy captures the information at presentation and does not convey the evolution of molecular features which lead to (or following) treatment resistance and disease progression.

While targeted anti-cancer drugs are personalized and based on molecular profiling of tumors, the selection of chemotherapy agents (which are the mainstay of treatment regimens in several cancers) are not based on such molecular guidance. There are presently no means to identify patients in whom the cancer is likely to respond to chemotherapy agents (or in whom it may not).
Hence treatment failure leads to disease progression as well as to accumulated toxicities from successive inefficient treatments.

Patients with advanced or difficult-to-treat cancers, especially where the cancer is not responding to treatments, require intelligently designed strategies for selection of personalized regimens that evaluates and addresses the molecular and functional dynamics of the tumor.

An ideal strategy effectively targets vulnerabilities of the tumor and also pre-emptively circumvents known resistance mechanisms.

Selection of combination regimens with targeted and cytotoxic anticancer agents may act synergistically to prevent escape mechanisms of the malignancy and reduce rates of drug resistance.

Such a strategy can lead to more effective treatments which reduce the risks of treatment failure as well as the risks of toxicities associated with treatment failure.

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About Exacta™

Exacta™ is a comprehensive in depth tumour gene expression analysis. It analyses 100’s of millions of data points at the molecular level to reveal all possible targets for precision drugs.

How does
Exacta™ work?

Exacta™ is an intensive and in-depth multi-analyte tumor profiling. It analyses millions of data points at the molecular and functional levels to reveal threats and vulnerabilities which enable optimal identification of targets for precision treatment selection. Exacta™ evaluates: Gene variants such as point mutations (SNV, Single Nucleotide Variants), Insertions and Deletions, Translocations, Rearrangements and Fusions, Differentially up or down-regulated gene transcripts, Activated or suppressed significant molecular pathways, Abundance of protein targets, In vitro chemosensitivity / chemoresistance profiles of tumor cells Exacta™ is agnostic to classical determinants such as primary organ, histological subtype, morphology (grade), aggressiveness and extent of disease.

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Reliable Technology

Exacta™ 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. In addition, Exacta™ also evaluates functional chemoresistance/chemosensitivity which is a consequence of the overall molecular dynamics. Exacta’s™ comprehensive, multi-analyte and meticulous assessment of the molecular and functional interactome of the malignancy is designed to provide relevant insights 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 Exacta™ for informing selection of patient-specific, safe and efficacious anti-cancer treatment regimens has been demonstrated in several clinical studies and case reports.

Methodology

Targeted Genes

SNVs, CNVs, Gene amplifications, Mutation burden,, Germline mutations

Immunocytochemical markers

mTOR, VEGFR1, VEGFR2, EGFR, VEGFA

RNA Sequencing

KEGG pathways (Disease, Actionable, Resistance)

Pharmacogenetics

Genotyping for CYP450, drug transporters for drug toxicity and efficacy

Chemosensitivity

Patented in vitro cell based assay for testing drugs identified

Liquid Biopsy

Mutation load, Tumour heterogeneity

Encyclopedic multi-analyte tumor profiling to identify functional and molecular features of the tumor which then inform selection of personalized anti-cancer treatment regimens.

Patients with advanced or difficult-to-treat cancers, especially where the cancer is not responding to treatments.

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How it Works?

Tumor components including malignant cells, proteins, DNA and RNA are isolated from tumor tissue and/or blood, analyzed by molecular and functional assays to identify features associated with response (or lack of response) to anti-cancer agents. These findings are integrated to generate patient-specific treatment regimens.

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Why should I get Checked?

CellDx™’s comprehensive, multi-dimensional and in-depth analysis of the cancer provides a detailed insight into tumor mechanisms. Such information has been clinically proven to help inform selection of safe and efficacious treatment regimens in cancers that do not respond to standard treatments.

Exacta™ is available for all solid organ cancers.

Exacta™ can provide therapeutically relevant insights into the tumor. This helps physicians to make more effective life-saving clinical management decisions. Download the brochure and sample reports below:

Advantages of Exacta™

Most Optimal Targeted Therapy Selection:
Exacta identifies possible molecular targets and cell cycle pathways to find the most appropriate molecular targets for targeted therapy.
Guides treatment selection in label compliant as well as off-label settings.
All relevant biomarkers for targeted therapy selection, including mutations, deletions, gene rearrangement, gene amplification / expression, are analysed. Includes assessment of all molecular biomarkers indicated in the National Comprehensive Cancer Network (NCCN) guidelines.
Assessment of adverse drug reactions:
Selection of therapy with least side effects based on analysis of germline.
Most Optimal Cytotoxic Therapy Selection:
Cytotoxic drug response / resistance of cancer genome, based on DNA and gene expression. Comprehensive exacta includes chemosensitivity testing for cytotoxic drug efficacy prediction.

Comprehensive Exacta

Parameters and Methods of Analysis

Exacta

Tumour DNA analysis

511 genes (tissue biopsy) / 409 genes (liquid biopsy)

Mutations and Gene Amplifications

Yes

Fusion / Rearrangements

51 genes (tissue biopsy) / 12 genes (liquid biopsy)

Tumour Gene Expression

20.805 genes

Cellular pathways as per KEGG

Yes

Chemosensitivity *

up to 60 drugs

Liquid Biopsy Cell free DNA (cfDNA)

Yes

ICC Immunocytochemistry (mTOR, VEGFR, EGFR, etc.)

Yes

Microsatellite Instability (MSI / MMR)

(tissue biopsy / liquid biopsy) Yes

Tumour Mutation Burden (TMB)

Yes

Relevant IHC, PD-L1, AR etc.

(tissue biopsy) Yes

Circulating Tumor Cells (CTCs)

Yes

Pharmacogenetic Guidance

Yes

Immunotherapy Guidance

Yes

Limit of Detection (MAF)

2.5 % (Tissue), 0.1 % (cfTNA)

Sensitivity at 0.1 % MAF (cfTNA)

97.06 %

Sensitivity at 2.5 % MAF

96.43 %

Positive Predictive Value

* Subject to availability of adequate sample.

100 %

Sample Requirements

40 ml blood in STRECK and EDTA tubes

Optional: 40 ml blood in STRECK and EDTA tubes as well as fresh tissue sample in DCGL transport media (4-6cm3 or 5 cores); alternative: FFPE tissue block

Precautions:

Please wait 24 hours after chemotherapy/PET-CT/MRI, before sampling blood.

Please wait 10 days after blood transfusion.

Turn Around Time (TAT):

10 – 14 days from receipt of the sample

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

Multi-analyte liquid biopsies for molecular pathway guided personalized treatment selection in advanced refractory cancers: A clinical utility pilot study

VIEW PDF       VISIT SITE   

Author: Patil D
Datar Cancer Genetics
Published Date: Dec 23, 2022

FAQ

Just as each patient is unique, so is each cancer. No two patients’ cancers are alike. Even two similar patients (e.g. age, gender, height, lifestyle) with the same type of cancer will have different molecular tumour profiles. Hence, each patient should perform an individual exacta test.

 

Cancer can be very aggressive and may evolve rapidly; the tumour profile can change dramatically over time. If there is a long enough delay the cancer may gain resistance to treatments and re-analysis may be required.

Only drugs that have been approved by the FDA will be recommended and be administered. These will include drugs that are FDA approved for use in same cancer / other cancer / other non-cancerous diseases.

Molecular tests like our cancertrack analysis allow the oncologist to monitor the therapy in real time. In addition, the test provides insights on genetic changes of the original tumour to adapt the therapy.

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