The concept and process for patients enrolled under the EXACTA therapy is as under:
(i) The freshly obtained tissue from a biopsy (or CTCs harvested from peripheral blood) is digested to
yield tumor cells which are then purified, characterized and divided into three aliquots – one to obtain DNA, one to obtain RNA and the remaining third aliquot is used for chemo-sensitivity analysis.
(ii) The DNA obtained from the tumor cells is sequenced to analyze all therapeutically significant genes and those genes which have impact due to Copy Number Variations (CNV), Single Nucleotide Variations (SNV), insertions, deletions, fusions and rearrangements. This covers all genes implicated in the NCCN guidelines as well as the TCGA.
(iii) The RNA obtained from the tumor cells (mRNA and miRNA) is also sequenced to decipher the cell cycle and cancer pathways and any other significantly dis-regulated pathway that impacts apoptosis, proliferation, metabolism, immune modulation and inflammatory networks.
(iv) From the data obtained consequent to (ii) and (iii) above, a shortlist of drugs / therapies which is anatomy independent (all approved cancer therapies irrespective of the organ or nature of malignancy) is prepared.
(v) The availability of top drug candidates is verified and the chemo-sensitivity assay for the top 20 drugs so identified is performed on the live tumor cells from aliquot no. 3.
(vi) Simultaneously, a pharmaco-genetics analysis is performed on the germ-line DNA to evaluate drug toxicity and the efficacy.
(vii) The data from (vi) and (vii) is then cross matched to formulate the best drug or the combination of drugs. This would include labelled, off label and repurposed drugs which are FDA approved for human
use as also high dose Vitamin C, Statins, Aspirin, and supplements such as Quercetin etc.
(viii) The final recommendation is then verified for drug-drug interactions and the same is released with detailed dosing suggestions.
PRIVATE & CONFIDENTIAL
(ix) The final report and recommendations are very extensive and provide comprehensive information in a neatly arranged format for easy understanding and action.
(x) All processes including wet lab, molecular lab and bio-informatics are performed in-house and are not outsourced.
4. The aforesaid process has evolved over the last 5 years of intensive research undertaken at the ultramodern molecular analysis facility of DCGL. The whole of the above analysis is performed with a TAT of 7 days. There is no other lab or institution in the world that comes anywhere close to the expanse, depth, direct utility, TAT and cost of the DCGL analysis.
5. All of DCGL processes are NABL and CAP accredited (the only facility in India to have all processes of molecular analysis in oncology so accredited).
6. DCGL employs a team of cancer biology specialists and molecular pathologists who are available round the clock for assistance.