No. 1 OncoRx Testing Company In Hyderabad - GenepoweRx


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Uploaded on Sep 27, 2022

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Our OncoRx reports are FDA-approved and the only ones available in India to the clinicians. They are simple, easy-to-read, accurate and have a relatively short turnaround time – all of which makes them an excellent choice for healthcare providers. Visit: https://genepowerx.com/oncorx/

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No. 1 OncoRx Testing Company In Hyderabad - GenepoweRx

Global Standard Testing in Oncology Now in India ONCORx helps you better predict response or resistance to targeted- and immuno- therapies for more advanced cancer patients as compared to traditional molecular testing. 1. Why ONCORX? ONCORx is testing solid tumours that uses next-generation sequencing (NGS) to detect the four alterations known to drive cancer growth: 1. SNP 2. InDels (Insertions and deletions) 3. Copy number Variants (CNVs), 4. Rearrangements or fusions. 2. How is ONCORx different from single-gene or “hot spot” testing? Single Marker or Hotspot Mutation testing can detect only one alteration where in ONCORx can provide insights on all four alterations. In other words, Single gene and hotspot testing do not look as deep or as wide as ONCORx. 3. Why ONCORx is superior to currently existing products? Compared to Foundation one/Datar/Core/Lal Path labs, ONCORx is validated through World’s only FDA approved database developed by collecting longitudinal data over 20 years by clinicians/Oncologists from Memorial Sloan Kettering Cancer Centre. ONCORx also provides partnership opportunity to develop dataset, 24/7 customer care representative. 4. What if there is no FDA approved targeted therapy for the tumor sample? ONCORx will provide best second line options for the patients as per NCCN guidelines. We will also provide with clinical trial match for the patient to enroll in leading institutions globally. BIOMARKERS FDA-APPROVED THERAPY Non-Small Cell Lung Cancer EGFR exon 19 deletions & EGFR exon 21 Gilotrif® (afatinib), Iressa® (gefitinib), L858R alterations Tagrisso® (osimertinib), or Tarceva® (erlotinib) EGFR exon 20 T790M alterations Tagrisso® (osimertinib) ALK rearrangements Alecensa® (alectinib), Alunbrig® (brigatinib) Xalkori® (crizotinib), or Zykadia® (ceritinib) BRAF V600E Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) MET single nucleotide variants (SNVs) and TabrectaTM (capmatinib) indels that lead to MET exon 14 skipping Breast Cancer ERBB2 (HER2) amplification Herceptin® (trastuzumab), Kadcyla® (ado- trastuzumab-emtansine), or Perjeta® (pertuzumab) PIK3CA C420R, E542K, E545A, E545D Piqray® (alpelisib) [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations Colo Rectal Cancer KRAS wild-type (absence of mutations in Erbitux® (cetuximab) codons 12 and 13) KRAS wild-type (absence of mutations in Vectibix® (panitumumab) exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) Ovarian Cancer BRCA1/2 alterations Lynparza® (olaparib) or Rubraca® (rucaparib) Prostate Cancer Homologous Recombination Repair (HRR) Lynparza® (olaparib) gene (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D and RAD54L) alterations All Solid Tumors TMB ≥ 10 mutations per megabase Keytruda® (pembrolizumab) NTRK1/2/3 fusions Vitrakvi® (larotrectinib) FOUNDATION ONE CDx GENEPOWERX ONCORx Targeted Genes and 325 Oncogenes NGS 325 Oncogenes NGS sequencing of Technology sequencing of FFPE samples FFPE samples SNP/INDEL/CNV YES YES Gene Fusions and YES YES Rearrangements Genomic Signatures YES YES TMB and MSI Analytics and Self-developed pipelines, Partnered with MSK's Precision Reporting FDA recognition for the Oncology Knowledge Base only FDA process recognised Database for 127 cancer types and 108 FDA approved drugs. Specific report for NO YES* Extensive Scientific literature Indian origin review on Published material specific population for Indian population. Research Opportunity NO YES* ONCORx team is partnering with Institutions, oncologists to build EHR solutions to develop longitudinal meaningful DATA. Guidelines Only FDA Approved Targeted Along with FDA Approved targeted treatments are reported treatments, NCCN guidelines are included. (Data proven Best second line treatments are recommended) Further Support NO YES* Tumour expression studies including Whole transcriptome sequencing, Germline sequencing by offering counselling for inherited mutations for family members is offered as per Oncologist request. Turn Around time 21 Working days 21 Working days Sample Requirement/ FFPE sample with minimum Initial quality measure is performed in 3 Quality confirmation 20ng genetic material. days and processed further only if protocols Minimal refund if quality of sample meets ONCORx standards. sample is poor Price INR 2,70,000/- INR 2,20,000/- Will work with physician hand to hand EMI Option NO Yes* Bajaj FinServ. Genes included in ONCORx for the detection of SNV, insertions and deletions (indels), and copy number alterations (CNAs). ABL1 BRAF CDKN1A EPHA3 FGFR4 IKZF1 MCL1 NKX2-1 PMS2 RNF43 TET2 ACVR1B BRCA1 CDKN1B EPHB1 FH INPP4B MDM2 NOTCH1 POLD1 ROS1 TGFBR2 AKT1 BRCA2 CDKN2A EPHB4 FLCN IRF2 MDM4 NOTCH2 POLE RPTOR TIPARP AKT2 BRD4 CDKN2B ERBB2 FLT1 IRF4 MED12 NOTCH3 PPARG SDHA TNFAIP3 AKT3 BRIP1 CDKN2C ERBB3 FLT3 IRS2 MEF2B NPM1 PPP2R1A SDHB TNFRSF14 ALK BTG1 CEBPA ERBB4 FOXL2 JAK1 MEN1 NRAS PPP2R2A SDHC TP53 ALOX12B BTG2 CHEK1 ERCC4 FUBP1 JAK2 MERTK NT5C2 PRDM1 SDHD TSC1 AMER1 BTK CHEK2 ERG GABRA6 JAK3 MET NTRK1 PRKAR1A SETD2 TSC2 APC C11orf30 CIC ERRFI1 GATA3 JUN MITF NTRK2 PRKCI SF3B1 TYRO3 AR CALR CREBBP ESR1 GATA4 KDM5A MKNK1 NTRK3 PTCH1 SGK1 U2AF1 ARAF CARD11 CRKL EZH2 GATA6 KDM5C MLH1 P2RY8 PTEN SMAD2 VEGFA ARFRP1 CASP8 CSF1R FAM46C GID4 KDM6A MPL PALB2 PTPN11 SMAD4 VHL ARID1A CBFB CSF3R FANCA GNA11 KDR MRE11A PARK2 PTPRO SMARCA4 WHSC1 ASXL1 CBL CTCF FANCC GNA13 KEAP1 MSH2 PARP1 QKI SMARCB1 WHSC1L1 ATM CCND1 CTNNA1 FANCG GNAQ KEL MSH3 PARP2 RAC1 SMO WT1 ATR CCND2 CTNNB1 FANCL GNAS KIT MSH6 PARP3 RAD21 SNCAIP XPO1 ATRX CCND3 CUL3 FAS GRM3 KLHL6 MST1R PAX5 RAD51 SOCS1 XRCC2 AURKA CCNE1 CUL4A FBXW7 GSK3B KMT2A MTAP PBRM1 RAD51B SOX2 ZNF217 AURKB CD22 CXCR4 FGF10 H3F3A KMT2D MTOR PDCD1 RAD51C SOX9 ZNF703 AXIN1 CD274 CYP17A1 FGF12 HDAC1 KRAS MUTYH PDCD1LG2 RAD51D SPEN AXL CD70 DAXX FGF14 HGF LTK MYC PDGFRA RAD52 SPOP BAP1 CD79A DDR1 FGF19 HNF1A LYN MYCL PDGFRB RAD54L SRC BARD1 CD79B DDR2 FGF23 HRAS MAF MYCN PDK1 RAF1 STAG2 BCL2 CDC73 DIS3 FGF3 HSD3B1 MAP2K1 MYD88 PIK3C2B RARA STAT3 BCL2L1 CDH1 DNMT3A FGF4 ID3 MAP2K2 NBN PIK3C2G RB1 STK11 BCL2L2 CDK12 DOT1L FGF6 IDH1 MAP2K4 NF1 PIK3CA RBM10 SUFU BCL6 CDK4 EED FGFR1 IDH2 MAP3K1 NF2 PIK3CB REL SYK BCOR CDK6 EGFR FGFR2 IGF1R MAP3K13 NFE2L2 PIK3R1 RET TBX3 BCORL1 CDK8 EP300 FGFR3 IKBKE MAPK1 NFKBIA PIM1 RICTOR TEK Genes for the detection of gene rearrangements: ALK introns 18, 19 BRCA1 introns 2, 7, 8, 12, 16, 19, 20 ETV4 intron 8 EZR introns 9- 11 KIT intron 16 MYC intron 1 NUTM1 intron 1 RET introns 7-11 SLC34A2 intron 4 BCL2 3’UTR BRCA2 intron 2 ETV5 introns 6, 7FGFR1 intron 1, 5, 17 KMT2A (MLL) introns 6-11 NOTCH2 intron 26 TERC ncRNA PDGFRA introns 7, 9, 11 ROS1 introns 31-35 BCR introns 8, 13, 14 MSH2 intron 5CD74 introns 6- 8 ETV6* introns 5, 6 FGFR2 intron 1, 17 NTRK1 introns 11RAF1 introns 4-8 RSPO2 intron 1 TERT Promoter BRAF introns 7-10 EWSR7-introns 7-13 FGFR3 intron 17 MYB intron 14 NTRK2 Intron 12 RARA intron 2 SDC4 intron 2 TMPRSS2 introns 1- 3 Features of OncoRx Intended use: A directional test for tumor profiling and drug decision making of FDA approved therapeutic molecules for approved biomarkers, hypothesis-driven translational research and biomarker development. Biomarkers covered conform OncoKB’s • Level1 (FDA approved drugs for FDA approved biomarkers), • Level2 (NCCN ratified standard care biomarker response to FDA approved drugs), • Level3 (Biomarkers with compelling clinical evidence to FDA Approved or investigational drugs) • R1 (standard care biomarkers with resistance to FDA approved drugs), • R2 (Biomarkers with compelling clinical evidence predictive of resistance to a oncodrug) evidences and Regions required for Tumor mutation burden-TMB, Microsatellite Instability –MSI assessment (FDA- approved for selection of solid tumors for treatment with checkpoint inhibition). Purpose: Assists in predicting outcomes of an FDA approved drug response, resistance, immunotherapy selection and management. Precision and Reporting : High performance standards, regulatory compliance, and quality control are ensured with automated protocols and pipelines. The test results are represented in 5 parts: Companion diagnostic Supportive Predisposition biomarker results evidences with to Resistance to with associated full proof therapeutic therapy scientific agents Other standard indication Other genomic evidences alterations care biomarkers profile-TMB,MSI. with associated therapy indication Biomarkers: Screens 353 potential genes - 174 suitable for characterizing cancer biomarkers with proven clinical utilities and an additional 179 high-confidence cancer genes which have emerging evidence in ongoing clinical trials. Coverage: Higher coverage (depth and extent of gene coverage) of 98% of regions of higher complexity. MSI Markers: MSI (FDA-approved for selection of Fusion coverage: Complete range of fusions with solid tumors for treatment with checkpoint multiple fusion partners can be identified in all inhibitors) is assessed by National Cancer solid tumors Institute recommended Bethesda panel and full Rearrangements: 16 potential biomarkers are footprint of other mismatch repair genes such as evaluated. MLH1, MSH2, MSH6 and PMS2. (ALK, BRAF, CD274, EGFR, ERG, ETV6, NTRK1, RAF, Tumor mutation burden (TMB): To identify an RET, ROS1, TERT, CD74, FOXA1, NAB2, NRG1, individual’s response to immunotherapeutic SLC34A2) agents such as checkpoint inhibitors, TMB is assessed with high precision, considering the Copy number variants (CNVs): 285 biomarkers large genome footprint and larger targeted panel screened for CNVs. size of 3.96 MB with high confidence cancer genes Regulatory regions of MAP2K2, TERT screened. enclosed. Higher cost due to large panel size Features of OncoRx Mini Intended use: Intended for use as a directional test for oncotherapy decision making. Biomarkers covered conform OncoKB’s • Level1 (FDA approved drugs for FDA approved biomarkers), • Level2 (NCCN ratified standard care biomarker response to FDA approved drugs), • R1 (standard care biomarkers with resistance to FDA approved drugs) candidate genes and • MSI (NCI and FDA-approved for selection of solid tumors for treatment with checkpoint inhibition). Purpose: Assists in predicting outcomes of an FDA approved drug response, resistance, immunotherapy selection and management. Precision and Reporting : High performance standards, regulatory compliance, and quality control are ensured with automated protocols and pipelines. The test results are represented in 3 parts: Companion diagnostic biomarker results Resistance with associated profile therapy indication MSI profile Biomarkers: Screens 71 candidate genes - which have the highest level of evidence in oncotherapy and are biomarkers for identification of response and resistance to oncotherapeutic agents. Coverage: Higher coverage of 99% due to targeted candidate gene panel design MSI Markers: MSI (FDA-approved for treatment of FGFR3- TACC3; solid tumors with checkpoint inhibitors) is NTRK1- CD74, EPS15, LMNA, MPRIP, TFG, TPR, assessed by biomarkers recommended by the TPM3; National Cancer Institute, Bethesda panel. NTRK2-ETV6; Tumor mutation burden (TMB): TMB cannot be assessed considering the targeted and restricted NTRK3- BTBD1, EML4, ETV6, HNRNPA2B1, KANK1, panel size. UBE2R2; Fusion coverage: Selective fusions with high PDGFB-COL1A1; level of evidence and can be identified with higher PDGFRA- KIF5B; confidence in all solid tumors due to screening of RET- EML4, TRIM33, KIF5B; fusion partners as well. ROS1-CD74, LIMA1. R e a r r a n g e m e n t s : O n c o K B a p p r o v e d rearrangements in 10 potential biomarkers Copy number variants (CNVs) : 71 biomarkers are along with their fusion partners are assessed. assessed. Rearrangements: Regulatory regions are not covered whereas complete exonic and splice site regions are ALK-EML4, NPM, RANBP2; screened. FGFR2- AHCYL1, BICC1 ,PPHLN1,TACC3; Lesser cost due to short panel size. Meet the doctors Dr. Kalyan Uppaluri is the cofounder Dr. Hima Challa graduated from and the owner of K&H Personalized Gandhi Medical College and was Medicine Clinic and Research among the top few in her batch. She Institute. He did his medical training specialized in Internal Medicine at St. at the prestigious Gandhi Medical Joseph Mercy Oakland, Michigan in College. He then moved to the the United States. She graduated in United States, where he specialized in Medical Genomics from the Ivy Internal Medicine at the McLaren league institution of Harvard Medical Hospital, Michigan. He also got a School. She also holds a master’s in degree in Medical Genomics from Ivy nutrition science from the Texas league institute, Stanford University Women University and in integrative and pursued cancer research at medicine from the Arizona University. Wayne State University, Michigan. www.genepowerx.com