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Mo.Re.? “

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What is the Mο.Re. assay?Mo.Re. (Molecular Response)  is a multi-gene assay developed to provide an insight to the tumor’s biology of each patient.

Understanding the unique biology of each patient’s tumor can assist in providing individualized treatment options. The development of a new technology called Next Generation Sequencing (NGS), allows us today to analyze multiple genes on the same sample simultaneously.

Mo.Re. is a widely validated assay that has been selected by the National Cancer Institute in the United States, as the assay of choice for stratifying more than 6000 patients that participate in the MATCH (Molecular Analysis for Therapy Choice) Clinical Trial to assign to them targeted treatments. MATCH is the first multi-centric clinical study that is based on pathway approach instead of organ approach. Mo.Re. is designed to help patients and physicians select targeted treatments and avoid the toxicity and other side effects of chemotherapy which has been already used with limited re-sponse and in some cases even resistance.

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This breakthrough technology along with cloud computing and bioinformatics work together in order to analyze massive volumes of data from the patients’ genome and transform it in an actionable report providing information on three main categories of results which are:

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On-label drugs- Drugs approved for this patient’s tumor type.

Off-label drugs- Drugs not approved for this patient’s tumor type but approved for a different tumor type. Clinical trials- Provide information on ongoing clinical trials based on this patient’s biology.

What is the Mο.Re. assay?

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Who should be tested?Who should be tested?

This test is designed for the following cases: Initial treatment plan is completed and more treatment options are needed.

Tumors without an established “gold standard” treatment. Tumors that are aggressive and do not respond to standard treatment. Rare tumors. Tumor types with many targeted treatment options available such as lung cancer.

Mo.Re. is designed in order to allow patients and physicians to se-lect which is the optimal targeted treatment based on the patient’s unique tumor biology.

Clinical Utility Mo.Re. provides valuable information that can be utilized to se-lect the optimal targeted treatment for patients. By analyzing many genes at the same time it provides a detailed blueprint of the biology of the tumor, which is used by the treating physician to design the patient’s treatment plan.

Actionable informationin almost 80% of the cases.

73% of the actionable cases will get at least one treatable mutation (on-label or off-label)

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Why choose Mo.Re.?

The universal oncology biomarker assay used, analyzes 161 unique cancer genes, including 87 oncogenes, 43 copy num-ber amplification (CNA) genes, 48 tumor suppressor genes, and 51 fusion driver genes. The content covers the most relevant cancer driver genes, including increased kinase domain coverage and representation of genes involved in DNA repair.

Sequencing is carried out using the Ion Torrent Next Gener-ation Sequencing platform Ion Proton (Thermo Fisher Sci-entific). The detection limit of the method is 2-5% of mu-tant allelic content, depending on the genomic region.

This technology has demonstrated high-reproducibility, sensitivity, and specificity. Thus it has been adopted by leading cancer institutions around the world, including the National Cancer Institute The NCI-MATCH (Molecular Anal-ysis for Therapy Choice) trial is the largest precision oncolo-gy basket trial which uses this NGS assay in order to assign patients to receive treatment based on the genetic changes found in their tumor regardless of tumor’s histology type.

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Testing Process-Quality Assurance:

MATCH: Molecular Analysis for Therapy Choice

The technology used to analyze the genes that are investigated during the testing process is called Next Generation Sequencing or NGS. The special-ized laboratories of GeneKor Medical S.A. are accredited by the Hellen-ic Accreditation Systems S.A (ESYD) under the terms of the ELOT EN ISO 15189:2012 (Cert. No. 822) and Certified with ELOT EN ISO 9001:2008 (Cert. No. 041150049) by TUV NORD HELLAS. Our services are assured by partici-pating in proficiency testing (PT) programs by: CAP, EMQN & UKNEQAS

First large multi-centric clinical study based on pathway ap-proach rather than an organ approach. Ion Torrent sequenc-ing and Oncomine Comprehensive Assay selected as best solution.

So-called basket studies which group cancer patients in a new way, could revolutionize the path from the lab to FDA approv-al and market success.

This precision medicine trial explores treating patiens based on the molecular profiles of their tumors. The biopsied tumor tissue will undergo gene sequencing. If a patient’s tumor has a genetic abnormality that matches one target by a drug used in the trial, the patient will be eligible to join the treatment portion on NCI-MATCH.

Clinical Trial

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NCI-MATCH IS FOR ADULTS WITH:· solid tumors

(including rare tumors) and lymphomas.· tumors that no

longer respond to standard treatment

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A Faster Way to Try Many Drugs on Many Cancers

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GENES ANALYZED147 gene alterations

AKT1 CDK12 FANCA IDH2 MSH2 PIK3CA RICTOR

AKT2 CDK2 FANCD2 IGF1R MSH6 PIK3CB RNF43

AKT3 CDK4 FANCI JAK1 MTOR PIK3R1 ROS1

ALK CDK6 FBXW7 JAK2 MYC PMS2 SETD2

AR CDKN1B FGF19 JAK3 MYCL POLE SF3B1

ARAF CDKN2A FGF3 KDR MYCN PPARG SLX4

ARID1A CDKN2B FGFR1 KIT MYD88 PPP2R1A SMAD4

ATM CHEK1 FGFR2 KNSTRN NBN PTCH1 SMARCA4

ATR CHEK2 FGFR3 KRAS NF1 PTEN SMARCB1

ATRX CREBBP FGFR4 MAGOH NF2 PTPN11 SMO

AXL CSF1R FLT3 MAP2K1 NFE2L2 RAC1 SPOP

BAP1 CTNNB1 FOXL2 MAP2K2 NOTCH1 RAD50 SRC

BRAF DDR2 GATA2 MAP2K4 NOTCH2 RAD51 STAT3

BRCA1 EGFR GNA11 MAPK1 NOTCH3 RAD51B STK11

BRCA2 ERBB2 GNAQ MAX NRAS RAD51C TERT

BTK ERBB3 GNAS MDM2 NTRK1 RAD51D TOP1

CBL ERBB4 H3F3A MDM4 NTRK2 RAF1 TP53

CCND1 ERCC2 HIST1H3B MED12 NTRK3 RB1 TSC1

CCND2 ESR1 HNF1A MET PALB2 RET TSC2

CCND3 ESR1 HRAS MLH1 PDGFRA RHEB U2AF1

CCNE1 EZH2 IDH1 MRE11A PDGFRB RHOA XPO1

51 fusion transcripts

AKT2 ALK AR AXL BRAF BRCA1 BRCA2

CDKN2A EGFR ERBB2 ERBB4 ERG ESR1 ETV1

ETV4 ETV5 FGFR1 FGFR2 FGFR3 FGR FLT3

JAK2 KRAS MDM4 MET MYB MUBL1 NF1

NOTCH1 NOTCH4 NRG1 NTRK1 NTRK2 NTRK3 NUTM1

PDGFRA PDGFRB PIK3CA PPARG PRKACA PRKACB PTEN

RAD51B RAF1 RB1 RELA RET ROS1 RSPO2

RSPO3 TERT

Genekor Medical S.A.52 Spaton Ave. 15344 Gerakas Greece Tel. +302106032138 Fax.+302106032148

info@genekor.com www.genekor.com