The most comprehensive tumour investigation
exacta® is a comprehensive analysis of tumours. exacta® allows a therapy recommendation to be made for most cancer patients, based on clinical evidence and experience. 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.
However, conventional ‘Standard of Care’ approach does not take into consideration the overall genetic architecture of a particular patient‘s tumour and consequently, patients could suffer due to failed therapies or aggressive relapse. It is, thus, imperative that the genetic 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 the driver mutations and pathways that are propelling a particular 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 ...
... first-line therapy has failed
... cancer has relapsed
... cancer is high-grade / metastatic
... newly diagnosed patients with difficult cancers such as stomach, oesophagus, pancreas, gall bladder, GIST etc.
... risk of therapy failure is high
Targeted GenesSNVs, CNVs, Amplifications, Mutation load, Germline mutations
RNA SequencingKEGG pathways (Disease, Actionable, Resistance)
PharmacogeneticsGenotyping for CYP450, drug transporters for drug toxicity and efficacy
ChemosensitivityIn vitro cell based assay for testing drugs identified, including other recommended combinations
Liquid BiopsyMutation load, Tumour heterogeneity
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. Confounding impact of simultaneous resistant molecular alterations on sensitizing mutations giving better therapy selection than single gene test based therapy.
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.
With recurrent or high grade cancer which has progressed despite therapy. exacta® can explore all possible therapeutic options by analysing all molecular alterations.
Longitudinal Disease / Therapy Monitoring:
Comprehensive exacta® enables effective tumour burden monitoring, therapy response monitoring and helps detect early therapy failure or recurrence.
Therapy Recommendation (TR):
Proprietary exacta® analysis provides best therapy combination option to treating physician.
Tumour DNA analysis452 genes ( tissue biopsy ) / 411 genes ( liquid biopsy )
Mutations and Gene Amplifications
Fusion / Rearrangements51 genes (tissue biopsy) / 12 genes (liquid biopsy)
Tumour Gene Expression20.805 genes
Cellular pathways as per KEGG
Chemosensitivity *up to 100 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)
PlatformsNGS, Microscopy, Arrays, ddPCR, CE
Therapy Recommendations (TR)
Sanger Sequencing to rule out germline nature of high MAF alterations
Sensitive ddPCR assays to detect therapy relevant low MAF alterations
Longitudinal Monitoring for MAF Comparisons of Repeat Tests
Limit of Detection (MAF)2.5 % (Tissue), 0.1 % (cfTNA)
Sensitivity at 0.1 % MAF (cfTNA)97.06 %
Sensitivity at 2.5 % MAF96.43 %
Positive Predictive Value100 %
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 452 / 411 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
30 ml blood in DCGL tube and EDTA tube both
Optional: 20 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
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
TR is a document that lists the various drugs (single drugs or drugs in combination) found to be beneficial for the patient based on detailed analysis of multiple biomarkers which is carried out during exacta® analysis. TR is given as part of the exacta® report. Based on the established efficacy and safety profile, these drugs are assigned a preference list. Where drug combinations may work better than single drugs, these will be indicated.
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 (e.g. lung) will have different molecular profile of tumours. Hence each patient should perform an individual exacta® test.
Therapy, based on the recommendations in TR, must be selected by the treating oncologist after suitability of the treatment has been determined as well as health and fitness of the patient have been evaluated. The selected treatment must be administered only under the supervision of the treating oncologist. The TR is only a recommendation of drugs that have high potential for success and benefit to the patient.
Cancer can be very aggressive and may evolve rapidly; the tumour profile can change dramatically over time. Starting the treatment immediately is essential as it is the best strategy to counter the aggressiveness of the cancer. 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. The TR will not recommend any investigational antineoplastic drugs / FDA-unapproved drugs.
Liquid biopsy can be extremely beneficial for real-time patient monitoring because it allows modification of therapy as well as recurrence monitoring when the patient is in remission. So, precision oncology molecular tests (cancertrack™) will not only provide information for selection of therapy, but will also allow the oncologist to monitor the therapy in real time and make decisions that will benefit quality of life, overall survival, progression free survival.