The most comprehensive tumour investigation

exacta is a comprehensive analysis of molecular-genetic characteristics of solid tumours based on the results of several clinical studies. Especially for rare solid tumours where no guidelines are available, in the advanced situation or for tumours that are difficult to treat, exacta is providing an advantage. exacta analyses millions of data points at the molecular level to identify all relevant targets for an individual therapy.

 

About exacta

However, conventional ‘Standard of Care’ approach does not take into consideration the overall genetic architecture of a particular patient‘s tumour. Consequently, patients could suffer due to failed therapies or aggressive relapse. It is, thus, imperative that the molecular architecture of the tumour is studied comprehensively before deciding the treatment plan, which has to be personalised to individual patients and their disease.

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.

exacta helps unravel driver mutations and pathways that are propelling a person’s cancer through multi-analyte and multi-coordinate analysis over 20.805 genes in the cancer genome. This analysis helps identify drugs that would be most effective for a particular solid tumour. exacta, thus enables a highly sophisticated treatment strategy beyond conventional perspective, even for difficult to treat or late stage cancers.

exacta is particularly recommended for cancer patients where ...

<p>... first-line therapy has failed</p>

... first-line therapy has failed

<p>... cancer has relapsed</p>

... cancer has relapsed

<p>... cancer is high-grade / metastatic</p>

... cancer is high-grade / metastatic

<p>... newly diagnosed patients with difficult cancers such as stomach, oesophagus, pancreas, gall bladder, GIST etc.</p>

... newly diagnosed patients with difficult cancers such as stomach, oesophagus, pancreas, gall bladder, GIST etc.

<p>... risk of therapy failure is high</p>

... risk of therapy failure is high

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

Advantages

Most Optimal Targeted Therapy Selection:
• exacta identifies possible molecular targets and cell cycle pathways to find the most appropriate molecular targets for targeted therapy.
• All relevant biomarkers for targeted therapy selection, including mutations, deletions, gene rearrangement, gene amplification / expression, are analysed.

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

Parameters and Methods of Analysis
  • Tumour DNA analysis
    511 genes (tissue biopsy) / 409 genes (liquid biopsy)
  • Mutations and Gene Amplifications
  • Fusion / Rearrangements

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

  • Tumour Gene Expression

    20.805 genes

  • Cellular pathways as per KEGG
  • Chemosensitivity *

    up to 60 drugs

  • Liquid Biopsy Cell free DNA (cfDNA)
  • ICC Immunocytochemistry (mTOR, VEGFR, EGFR, etc.)
  • Microsatellite Instability (MSI / MMR)

    (tissue biopsy / liquid biopsy)

  • Tumour Mutation Burden (TMB)
  • Relevant IHC, PD-L1, AR etc.

    (tissue biopsy)

  • Circulating Tumor Cells (CTCs)
  • Pharmacogenetic Guidance
  • Immunotherapy Guidance
  • 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

    100 %

* Subject to availability of adequate sample.

100s of Millions of Data Points Analyzed

(from Peripheral Blood and / or Fresh Tissue and / or FFPE Block / or Liquor)

Cell Free DNA

Exosomal 20.805 mRNAs

Driver Mutations; Rearrangements; Insertions and Deletions from 511 / 409 genes

Direct Live Tumour Cell Assessment

Tumor Cell Cycle Pathways

+

Artificial Intelligence / Database based, multi-level iterative algorithm to determine optimum (most favorable + least toxic) drugs and drug combinations

=

Therapy Recommendations

Sample requirement

,

25 ml blood in DCGL tube and EDTA tube both

Optional: 15 ml blood in DCGL tube and EDTA tube both 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

Contact

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

Dr. Stefan Schuster

Managing Director Europe

FAQ

If two patients have the same histopathological cancer type, and one of them undergoes exacta analysis, can the other patient receive the same treatment as indicated for the first patient?

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.

Why is it important to start treatment immediately?

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.

What kind of drugs will be recommended to the patient?

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.

Are there any follow-up molecular tests to assess the result of recommended therapy?

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.