India’s Best Selling Cancer Genomics Test · Cancer Genomics Test # 1 Precision treatment for...

PositiveSelect is India’s widely used Cancer Genomics test with every 8 out of 10 patients opting for PositiveSelect

PositiveSelect is available as 4 different tests offering solutions for every type of cancer patient

Genomics is finally affordable to every patient

India’s Best Selling Cancer Genomics Test

# 1

Precision treatment for every Cancer Patient

Patient Guide

Bioscience our job is to provide you, our customer, with the very best and highest quality test. The goal of PositiveSelect is to help you get on the best treatment.

Positive Bioscience was established with the goal of providing the best possible technology India’s Leading Cancer Genomics Testing

Company.

Positive Bioscience thanks you for considering our testing and we look forward to serving you.

Dear Valued Customer,

Yours Sincerely,

Dr. Sandhya IyerSenior Scienti�c O�cer

Key bene�ts of PositiveSelect

Aids routine molecular diagnostics

PositiveSelect aids routine molecular diagnostics in Lung, Colorectal cancer (CRC), Melanoma, Gastric and Ovarian Cancer

It covers >80% of routine molecular diagnostics in Breast, Head and Neck, Prostate and Pancreatic cancer

1Improve Treatment Outcome by upto 300%

PositiveSelect checks millions of data points and hundreds of treatment options to select the best one

Treatment recommendations are tailored to the patient’s genetic profile

2

Cut Treatment Costs

PositiveSelect removes the trial and error approach

Getting on the best treatment quickly saves money

3

PositiveSelect helps to avoid dangerous and toxic side effects

Treatments selected based on genetic profiling minimize side effects

4

Most Comprehensive Test

PositiveSelect tests for hundreds of genes on Next Generation Sequencing (NGS)

Every gene is tested 1000 times to ensure accuracy

Tests for all types of genomic alterations, mutations, insertions, deletions, translocations, fusions, rearrangements and amplifications

5All Cancer types Covered

PositiveSelect can test every cancer type and stage

If tumor is not available we test on blood (Ct-DNA)

6

Reduce Side Effects

Tests performed

Universal Molecular Diagnostics

Sample Requirement (FFPE/Blood)

Patient profile

Genes

Industry leading coverage

Indels/ Base Substitutions/ Amplifications/ Rearrangements/ Fusions

Sensitivity

Specificity

Pharmacogenomics

Off Label Drugs

True Somatic Mutations

True Germline Mutations

Pathway Analysis

Tumour Mutation Load

MSI (Microsatellite instability)

Driver Mutations

Expert Commentary

Expert Consultation

Features and

Number of tests performed

Aids conventional molecular diagnostics

Convenience and accuracy in molecular profiling

Ideal patients for the test

Number of Genes tested

Improves accuracy

Drug response and prognosis

Test with > 90% sensitivity is considered gold standard

Test with > 90% specificity is considered gold standard

Drug response and prognosis

Treatment options outside guidelines

True actionable driver mutations

Hereditary association

Accurate treatment decisions

Useful for Immunotherapy

Useful for Immunotherapy

Helps in determining precise treatment options

Helps treating clinican understand genetic perspective

Consultation with genetic expert to precise treatment

Features Benefits

PositiveSelect Lite

PositiveSelect Plus

PositiveSelect Match

PositiveSelect Ultimate

Benefits of Product

100 100 + 100 350 350 + 350

>90% >90%>90% >90%

>90% >90%>90%

31% more accurate 31% more accurate

>90%

Introductory test for newly diagnosed patients

Intermediate test for first line failures

Advanced test for advanced cancers

Most advanced test for advanced cancers

1000x 1000x 1000x + 1000x 1000x + 1000x

As cancer is a life-threatening disease Positive Bioscience recommends PositiveSelect Ultimate for every patient for best chances of survival

Tumour Sample Only Tumour Sample Only Tumour Sample + Normal Sample Tumour Sample + Normal Sample

Newly Diagnosed 1st Line failure/ Rare Cancers

1st Line failure/Family history of cancer/relapse

Aggressive/rare cancer/patients with no treatment options as per guidelines

Genomic profiling in CancerCancer is a genetic disease caused by changes in DNA

These changes trigger an abnormal cell growth which forms tumour that invade healthy organs and tissue

Many genes can cause cancer

Two people having same cancer affecting the same body part are most likely different at genetic level and will respond differently

BRCA1, BRCA2, STK11, TP53, PTEN, CDH1, PALB2, ATM, CHEK2, NBN, BARD1, BRP1, RAD51C Breast

STK11, APC, BMPR1A, SMAD4, APC, BMPR1A, SMAD4, MUTYH, TP53, PTEN, CDH1, CHEK2 Colorectal

MLH1, MSH2, MSH6, PM52, EPCAM, STK11, TP53, PTEN Endometrial

MLH1, MSH2, MSH6, PM52, EPCAM, STK11, APC, BMPR1A, SMAD4, TP53, CDH1 Gastric

BRCA1, BRCA2, CDKN2A, CDK4, TP53 Melanoma

MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, BRP1, RAD51C, RAD51D Ovarian

APC, BMPR1A, SMAD4, CDKN2A, CDK4, TP53, PALB2, ATM Pancreatic

BRCA1, BRCA2, TP53, CHEK2, NBN Prostate

CANCER CAUSING GENES CANCER

Cancer patients areoften treated by the

one-size-fits-all regimen

Many cancer patients fail in their first line therapy

>Most cancer patients dont respond to standard treatment

50 %*

HER2

ALK

EGFR

Lung Cancer Patients

Gefitinib

Crizotinib

Trastuzumab

Lives 60% more compared to patients who have not done genomic profiling

Patients treated as per genomic profile lives 60% moreGenomic Profile not Done

Genomic Profile Done

Genomic profiling increases your chances of survival byIdentifying genetic variations that can be targeted using better Targeted therapies (e.g Gefitinib in EGFR positive cases)Helps avoid drugs which will be ineffective thereby reducing side effects (e.g. KRAS mutation to determine efficacy of Cetuximab)

All American Hospitals use Cancer Genomics Testing

1. MD Anderson

2. Memorial Sloan Kettering

3. Mayo Clinic

4. Dana Farber

5. Johns Hopkins

EGFR (Mutation)

ALK (Rearrangement)

KRAS (Mutation)

ROS1 (Rearrangement)

RET (Rearrangement)

PD-L1 (Expression)

BRAF (Mutation)

ER (Expression)

VEGF (Mutation)

BCR-ABL (Translocation)

MTOR (Mutation)

Trastuzumab

Crizotinib

Cetuximab

Crizotinib

Cabozantinib

Pembrolizumab

Vemurafenib

Tamoxifen

Bevacizumab

Imatinib/Dasatinib/Nilotinib

Everolimus

Standard Therapy

PositiveSelect is a must do test for

Single moleular diagnostic test covers all routine molecular tests Tests for 100 genes including EGFR, KRAS, PIK3CA, HER2, BRAF, ALK, ROS1, RET, MET available at affordable priceCovers nearly all National Comprehensive Cancer Network (NCCN) recommendations in a single testPositiveSelect Lite also gives drug recommendations associated with the 100 genes that are tested

All newly diagnosed solid tumours

Patients looking for molecular diagnostic tests

Lite

PositiveSelect aids routine molecular diagnostics

Ideal for newly diagnosed solid tumours

List of important genes covered as per Cancer type

Lite

All NCCN genes covered

Complete Replacement

Lung, Colorectal (CRC), Kidney, Ovarian cancer

Most (80%) NCCN genes covered

Add OnTests

Breast, Prostate, CNS, Head and Neck cancer

Lung EGFR, ALK, KRAS, HER2, BRAF, MET, ROS1, RET

Breast HER2, BRCA1, BRCA2, TP53, ESR1

Ovarian BRCA1, BRCA2

CRC NRAS, KRAS, BRAF, TP53, MLH1, MSH2, MSH6

Pancreatic KRAS, TP53, EGFR

Prostate PTEN, AR, BRCA1, BRCA2

Kidney VHL

PositiveSelect Lite: Testing Process

Lite

Genes Analyzed 100

Sequencing Method Illumina Next Generation Sequencing

Bioinformatics

Assay Sensitivity >90%

Assay Specificity >90%

Sequencing Coverage 1000x

Turnaround Time 4 weeks

Sample Requirements

Sample Types

6-8 ml of blood each in 2 ’Streck’ tubesOr FFPE sample (tissue size >=40µm having atleast 30% malignant cells)

Whole Bloodor Tumour

DNA Input Required 300 – 500 ng

PositiveSelect Lite Technical Specification

Sample Required Biomarkers Tested

100 cancer driving genes at 1000x

coverage

Routine molecular diagnostics and

Pharmacogenomics

Aids routine diagnostics

Bioinformatics Reporting

or

FFPE sample or 6-8ml of Blood each

in 2 Streck tubes

Lite


Use of our trademark TEST (Targeted Enrichment Sequencing for Therapeutics) pipeline for analysis and annotation

of Report: Pharmacogenomics Section

Lite

Therapies with benefit highlighted by a green tick

Therapies with lack of benefit highlighted by a red tick

Easy to understand report format

Pharmacogenomics information given on the first page

Second page covers molecular testing details Ideal for newly diagnosed solid tumours

PATIENT PHYSICIAN

Name :

Date of Birth :Gender :

Name :

Institute :

SAMPLE

Sample Type : Sample Collection Date :

Report Date :

Sample ID :

XXX

Plasma --/--/2017

Coverage :Technology : 1000xTest : PositiveSelect Lite --/--/2017

PB_CG_SL_2017-18_X

F --/--/---- XXX Hospital

Dr. XXX

Illumina NGS

Diagnosis : Squamous Cell Carcinomaof Lung

Patient Tumor Type Speci�c Genes

ResultGenetic AlterationGene

NegativeAKT1

NegativeFGFR1

EGFR

NegativeMAP2K1

KRAS

No alteration detected NegativeNRAS

No alteration detected



NegativeALK

Negative

DDR2 Negative

ERBB2


Negative

BRAF


NegativeMET No alteration detected

NegativePTEN No alteration detected

NegativePIK3CA No alteration detected

NegativeRET No alteration detected

NegativeROS1 No alteration detected

Note: All the genomic alterations relevant to the cancer type (Lung Cancer) and the associated genes as per NCCN and mycancergenome.org are reported here.

Exon 19 deletion Positive

NegativeNo alteration detected



[Glu746_Ala750del]

Genes Covered in PositiveSelect LitePOINT MUTATIONS (>99% Sensitivity)

FUSIONS (>90% Sensitivity)

INSERTION/DELETIONS (INDELS)(>95% Sensitivity)AMPLIFICATIONS

ABCB1

ABCC1

ABCC2

ABCC3

ABCC4

ABCG2

ABL1

AKT1

ALK

AR

BCR

BRAF

BRCA1

BRCA2

BTK

CCND1

CCND2

CDA

CDK4

CDK6

CYP19A1

CYP1A1

CYP1A2

CYP1B1

CYP24A1

CYP27B1

CYP2B6

CYP2C19

CYP2C9

CYP2E1

CYP3A4

CYP3A5

DCK

DDB1

DDR2

DYNC2H1

EGFR

EML4

ERBB2 (HER2)

ERCC1

ERCC2

ERCC3

ERCC4

ERCC5

ESR1 (ER)

EWSR1

EZH2

F2R

FGFR1

FGFR2

FGFR4

FLT3

GSTA1

GSTP1

HIF1A

HRAS

IDH1

IGF1R

IL6

JAK1

JAK2

JAK3

KDR

KIT

KRAS

LINS1

MAP2K1

MAP2K2

MAPK1

MET

MLH1

MSH2

MSH6

MTHFD1

MTHFR

MTOR

NF1

NR1I2

NR1I3

NRAS

PARP1

PDCD1 (PD1)

PDGFRA

PDGFRB

PGR (PR)

PIK3CA

PTEN

REL

RET

ROS1

RRM1

STAT3

TERT

TOP1

TP53

TSC1

TSC2

VEGFA

VHL

XRCC1

ALK

FGFR2

RET

ROS1

AR

CCND1

CCND2

ERBB2

FGFR2

KRAS

PIK3CA

BRAF

CDK4

EGFR

FGFR1

KIT

MET

PDGFRA

BRCA1

EGFR

ERBB2

KIT

MET

MLH1

MTOR

NF1

PDGFRA

PTEN

TP53

TSC1

VHL

Lite


Plus

Comprehensive genomic profiling using Next Generation Sequencing

Tests 350 genes

PositiveSelect Plus detects all classes of genomic alterations, including point substitutions, insertions and deletions (indels), copy number alterations (CNAs) and rearrangements using cfDNA or FFPE sample

Industry leading coverage of 1000x

Benefits of PositiveSelect Plus

Identifies genomic alterations associated with clinical benefit

Provides Targeted Therapy

Gives information on Tumour Mutation Burden

Gives information on Microsatellite Instability Status

Quantifies clinical markers associated with immunotherapy response

Identifies relevant Clinical Trials

Ideal for 1st line failure/Rare cancers

Plus

Genes Analyzed 350


BioinformaticsUse of our trademark TEST (Targeted Enrichment Sequencing for Therapeutics) pipeline for analysis and annotation





Sample Requirements

Sample Types

6-8 ml of blood each in 2 ’Streck’ tubesOr FFPE sample (tissue size >=40µm having atleast 30% malignant cells)


PositiveSelect Plus Technical Specification

PositiveSelect Plus: Testing Process

Sample Required Biomarkers Tested Bioinformatics Reporting

or

Plus

FFPE sample or 6-8 ml of Blood each

in 2 Streck tubes

350 cancer driving genes at 1000x

coverage

Mapping for treatment options and clinical trials

Contains PGX, TMB, MSI


Whole Bloodor Tumour

Report

Plus


ResultGenetic AlterationGene

Note: All the genomic alterations relevant to the cancer type (Pancreas Adenocarcinoma) and the associated genes as per NCCN are reported here.

GENOMIC ALTERATIONS WITH THERAPEUTIC IMPLICATIONS

Additional Findings

Microsatellite status MS-Unstable

Tumor Mutation Burden TMB-High

TP53 NegativeNo alteration detected

Positive

PLUS

PATIENT PHYSICIAN

Name :


Name :

Institute :

SAMPLE


Report Date :

Sample ID :

XXX

Plasma --/---/2017

Coverage :Technology : 1000xTest : PositiveSelect Plus --/---/2017

PB_CG_SP_2017-18_X

M --/---/---- XXX Hospital

Dr. XXX

Illumina NGS

Diagnosis : Pancreas Adenocarcinoma

PATIENT TUMOR TYPE SPECIFIC GENES

KRAS Positivep.G12D

CDKN2A Positivec.131dupA

Positive

SMAD4 NegativeNo alteration detected

Plus

Genes Covered in PositiveSelect PlusPOINT MUTATIONS (>99% Sensitivity)

ABCB1

ABCC1

ABCC2

ABCC4

ABCG2

ABL1

AKT1

AKT2

AKT3

ALK

ALOX12B

AMELY

APC

AR

ARAF

ARID1A

ASXL1

ASXL2

ATM

ATR

ATRX

AURKA

AURKB

AXIN1

AXIN2

AXL

B2M

BAP1

BARD1

BBC3

BCL2

BCL2L1

BCL2L11

BCL6

BCOR

BCR

BLM

BRAF

BRCA1

BRCA2

BRD4

BRIP1

BTK

CARD11

CASP8

CBFB

CBL

CCND1

CCND2

CCND3

CCNE1

CD274

CD276

CD79B

CDC73

CDH1

CDK12

CDK4

CDK6

CDK8

ALK

FGFR2

FGFR3

RET

ROS1

NTRK1

AR

CCNE1

CCND1

CCND2

ERBB2

FGFR2

KRAS

PIK3CA

MYC

PD-L1

BRAF

CDK4

CDK6

EGFR

FGFR1

KIT

MET

PDGFRA

RAF1

ATM

APC

ARID1A

BRCA1

BRCA2

CDH1

CDKN2A

EGFR

ERBB2

GATA3

KIT

MET

MLH1

MTOR

NF1

PDGFRA

PTEN

RB1

SMAD4

STK11

TP53

TSC1

VHL

CDKN1A

CDKN1B

CDKN2A

CDKN2B

CDKN2C

CHEK1

CHEK2

CREBBP

CRKL

CRLF2

CSF1R

CTCF

CTLA4

CTNNB1

CUL3

CYP19A1

CYP1A1

CYP1A2

CYP1B1

CYP2A4

CYP2A6

CYP2B6

CYP2E1

DAXX

DAZ1

DDR2

DICER1

DIS3

DNMT1

DNMT3A

DNMT3B

DOT1L

E2F3

EGFL7

EGFR

EML4

EP300

EPCAM

EPHA3

EPHA5

EPHB1

ERBB2

ERBB3

ERBB4

ERCC2

ERCC3

ERCC4

ERCC5

ERG

ESR1

ETV1

ETV6

EWSR1

EZH2

FAM123B

FANCA

FANCC

FAT1

FBXW7

FGF19

FGF3

FGF4

FGFR1

FGFR2

FGFR3

FGFR4

FH

FLCN

FLT1

FLT3

FLT4

FOXA1

FOXL2

FOXP1

FUBP1

GATA1

GATA2

GATA3

GNA11

GNAQ

GNAS

GSK3B

GSTA1

GSTP1

HGF

HIF1A

HIST1H3B

HNF1A

HRAS

IDH1

IDH2

IFNGR1

IGF1

IGF1R

IGF2

IKBKE

IKZF1

IL10

IL7R

INSR

IRF4

IRS1

IRS2

JAK1

JAK2

JAK3

JUN

KDM5A

KDM5C

KDM5D

KDM6A

KDR

KEAP1

KIT

KLF4

KRAS

LATS1

LATS2

LMO1

MAP2K1

MAP2K2

MAP2K4

MAP3K1

MAP3K13

MAPK1

MAX

MCL1

MDC1

MDM2

MDM4

MED12

MEF2B

MEN1

MET

MITF

MLH1

MLL

MLL2

MLL3

MPL

MSH2

MSH6

MTHFD1

MTHFD1L

MTHFR

MTOR

MUTYH

MYC

MYCL1

MYCN

MYD88

MYOD1

NBN

NCOR1

NF1

NF2

NFE2L2

NKX2-1

NKX3-1

NOTCH1

NOTCH2

NOTCH3

NOTCH4

NPM1

NR1I2

NRAS

NSD1

NTRK1

NTRK2

NTRK3

NUTM1

PAK1

PAK7

PALB2

PARK2

PARP1

PAX5

PAX8

PBRM1

PDCD1

PDGFRA

PDGFRB

PDPK1

PGR

PIK3C2G

PIK3C3

PIK3CA

PIK3CB

PIK3CD

PIK3CG

PIK3R1

PIK3R2

PIK3R3

PIM1

PLK2

PMAIP1

PMS1

PMS2

PNRC1

POLE

PPP2R1A

PRDM1

PRKAR1A

PRKY

PTCH1

PTEN

PTPN11

RAC1

RAD50

RAD51

RAD51B

RAD51C

RAD51D

RAD52

RAD54L

RAF1

RARA

RASA1

RB1

RECQL4

REL

RET

RFWD2

RHOA

RICTOR

RIT1

RNF43

ROS1

RPS4Y2

RPS6KA4

RPS6KB2

RPTOR

RUNX1

RYBP

SDHA

SDHAF2

SDHB

SDHC

SDHD

SETD2

SF3B1

SH2D1A

SLC22A1

SMAD2

SMAD3

SMAD4

SMARCA4

SMARCB1

SMO

SOCS1

SOX17

SOX2

SOX9

SPOP

SRC

SRY

STAG2

STK11

STK40

SUFU

SYK

TBX3

TERT

TET1

TET2

TGFBR1

TGFBR2

TMEM127

TMPRSS2

TNFAIP3

TNFRSF14

TOP1

TP53

TP63

TRAF7

TSC1

TSC2

TSHR

TSPY4

TTTY23

TYMS

U2AF1

USP9Y

VHL

WT1

XIAP

XPO1

YAP1

YES1

ZFY


INSERTION/DELETIONS (INDELS)(>95% Sensitivity)

AMPLIFICATIONS


PositiveSelect Match is India’s first Cancer Genomics test which tests both tumour and normal sample

Testing variations in both tumour and normal sample helps identify true somatic mutations which are driving cancer. Once true driver mutations are identified patients can be treated with confidence

100 genes tested on NGS in tumour and normal sample

Helps find out true somatic and germline mutations

Improves accuracy of finding driver mutation by 31%

Provides better treatment options thereby improving survival chances

Benefits of PositiveSelect Match

Identifies true driver mutations

Identifies true Somatic mutations

Identifies Germline mutations

Improves accuracy of Genomic Profiling by 31%

Universal diagnostics

Identifies HBOC, Lynch Syndrome

Helps in knowing risk of inheritance of faulty genes in the family

Match

Ideal for 1st line failure/family history of cancer/relapse

Genes Analyzed 100








PositiveSelect Match Technical Specification

Match

PositiveSelect Match: Testing Process


Sample Required Biomarkers Tested Bioinformatics Reporting

or

Match

FFPE sample or 6-8ml of Blood each in 2 Streck tube & 4ml in EDTA tube

100 cancer driving genes on

tumour and normal sample at 1000x


Report contains PGX, True Germline, True Somatic

Mutations

Sample Requirements

Sample Types

6-8 ml of blood each in 2 ’Streck’ tubes and 3-4 ml of blood in EDTA tubeor FFPE sample and 3-4 ml of blood in EDTA tube

Blood in Streck tubes and in EDTA tubeor Tumour and Whole Blood in EDTA tube


Report

Match

Easy to understand report format

Pharmacogenomics information given on the first page followed by molecular tests

Green tick indicates beneficial treatment options

Red tick denotes treatment options with lack of benefit

Therapies with benefit highlighted by a green tick

Therapies with lack of benefit highlighted by a red tick

THERAPIES WITH POTENTIAL BENEFIT

Result Targeted PathwaysDrugs Gene

mTOR/PIK3CA inhibitors [Everolimus, Temsirolimus/Buparlisib, Taselisib]

PI3K/MTOR signaling pathway

PositivePIK3CA[E542K]

THERAPIES WITH POTENTIAL LACK OF BENEFIT

Result Targeted PathwaysDrugs Gene

PATIENT PHYSICIAN

Name :


Name :

Institute :

SAMPLE


Report Date :

Sample ID :

XXX

Plasma --/---/2017

Coverage :Technology : 1000XTest : PositiveSelect Match --/---/2017

F --/---/----

Dr. XXX

Illumina NGS

Diagnosis : Ca Peritoneal Ovarian with Renal Mets

XXX Hospital

PB_CG_SM_2016_X

MEK Inhibitors [Trametinib]

KRAS/BRAF/MAPK signaling pathway

PositiveKRAS[G13C]

[Cetuximab/Panitumumab]EGFR inhibitors KRAS

[G13C]Positive KRAS/BRAF/MAPK signaling

pathway

No germline pathogenic variants detected in BRCA1/2 genes. Hence the patient is less likely to benefit from PARP inhibitors(Olaparib)

Note: Patients with mutated KRAS are less likely to benefit from EGFR inhibitors (Cetuximab and Panitumumab)

[Olaparib]PARP inhibitors BRCA1/2 Negative Homologous Recombination

Genes Covered in PositiveSelect MatchPOINT MUTATIONS (>99% Sensitivity)

FUSIONS >90% Sensitivity

INSERTION/DELETIONS (INDELS)>90% Sensitivity

AMPLIFICATIONS

ABCB1

ABCC1

ABCC2

ABCC3

ABCC4

ABCG2

ABL1

AKT1

ALK

AR

BCR

BRAF

BRCA1

BRCA2

BTK

CCND1

CCND2

CDA

CDK4

CDK6

CYP19A1

CYP1A1

CYP1A2

CYP1B1

CYP24A1

CYP27B1

CYP2B6

CYP2C19

CYP2C9

CYP2E1

CYP3A4

CYP3A5

DCK

DDB1

DDR2

DYNC2H1

EGFR

EML4

ERBB2 (HER2)

ERCC1

ERCC2

ERCC3

ERCC4

ERCC5

ESR1 (ER)

EWSR1

EZH2

F2R

FGFR1

FGFR2

FGFR4

FLT3

GSTA1

GSTP1

HIF1A

HRAS

IDH1

IGF1R

IL6

JAK1

JAK2

JAK3

KDR

KIT

KRAS

LINS1

MAP2K1

MAP2K2

MAPK1

MET

MLH1

MSH2

MSH6

MTHFD1

MTHFR

MTOR

NF1

NR1I2

NR1I3

NRAS

PARP1

PDCD1

PDGFRA

PDGFRB

PGR (PR)

PIK3CA

PTEN

REL

RET

ROS1

RRM1

STAT3

TERT

TOP1

TP53

TSC1

TSC2

VEGFA

VHL

XRCC1

ALK

FGFR2

RET

ROS1

AR

CCND1

CCND2

ERBB2

FGFR2

KRAS

PIK3CA

BRAF

CDK4

EGFR

FGFR1

KIT

MET

PDGFRA

BRCA1

EGFR

ERBB2

KIT

MET

MLH1

MTOR

NF1

PDGFRA

PTEN

TP53

TSC1

VHL

Match


Ultimate

Most comprehensive Cancer Genomics test available

Matched NGS analysis on Tumour and Normal sample, testing 350 genes

Only cancer genomics test in the world which covers:

Pathway Analysis

Tumour Mutation Burden (TMB)

Microsatellite Instability (MSI)

True Somatic Mutations

True Germline Mutations

Targeted Therapy

Chemotherapy

Clinical Trial

Hereditary testing for HBOC and Lynch Syndrome

Benefits of PositiveSelect Ultimate

Provides the best chance of beating cancer

Provides a 3D view of genomic profiling by accurately determining True Somatic, True Germline and True Driver mutations

Provides treatment solution based on cancer pathways increasing the odds of beating cancer manyfold

Immunotherapy options based on Microsatellite instability and Tumour Mutation Burden

Expert commentary with every report

Expert consultation with treating doctor to analyse and treat patients in a holistic manner

Ideal for aggressive/rare cancers and patients with no treatment options

Genes Analyzed 350







Sample Requirements

Sample Types

6-8 ml of blood each in 2 ’Streck’ tubes and 3-4 ml of blood in EDTA tubeor FFPE sample and 3-4 ml of blood in EDTA tube

Blood in Streck tubes and in EDTA tubeor Tumour and Whole Blood in EDTA tube


PositiveSelect Ultimate: Testing Process

PositiveSelect Ultimate Technical SpecificationUltimate


Sample Required Biomarkers Tested Bioinformatics ReportingUltimate

or

FFPE sample or 6-8ml of Blood each in 2

Streck tubes & 4ml in EDTA tube

350 cancer driving genes on

tumour and normal sample at 1000x


Most comprehensive Cancer Genomics report

EXPERT COMMENTARY

GENOMIC HIGHLIGHTS

IMPLICATIONS TO IMMUNOTHERAPY

4 Pathways driving cancer

7 Genomic alterations

0 Genomic alterations with clinical lack of bene t

4 Clinical trials

MSI-Stable

TMB-High

Microsatellite status

Tumor Mutation Burden

PATIENT PHYSICIAN

Name :


Name :

Institute :

SAMPLE


Report Date :

Sample ID :

XXX

Plasma & Blood --/---/2017

Coverage :Technology : 1000XTest : PositiveSelect Ultimate --/---/2017

PB_CG_SU_2017-18_X

M --/---/---- XXX Hospital

Dr. XXX

Illumina NGS

Diagnosis : Signet ring cell carcinomaof stomach cancer

Note: Complimentary call for consultation is available.

Note: TMB-Low :- <19 mutations/MB, TMB-High - >20 mutations/MB; MS-Stable <2% unstable sites, MS-Unstable >2% unstable sites

NOTCH4 mediated MTOR signaling pathway

MUTYH - A95W

6 Genomic alterations with clinical actionability

BRCA2 - T2412I

KRAS signaling pathwayCell cycle signaling pathwayDNA repair pathway

NOTCH4 - AmplificationKRAS - Amplification (equivocal)CDK4 - Amplification (equivocal)FGF19 - Amplification (equivocal)

The patient was diagnosed with signet-ring cell carcinoma of the stomach with lower esophagus, gastric cardia and fundus metastases and was treatedwith chemotherapy.

We identified six clinically actionable genomic alterations [BRCA2 (T2412I), CDK4, NOTCH4, KRAS, and FGF19 amplification] and high tumor mutationburden. Studies have documented the effect of NOTCH4 amplification which continously activates PI3K/AKT/MTOR pathway inturn resulting in tumori-genesis. Gamma secretase inhibitors targeting NOTCH4 receptors and MTOR inhibitor could prove beneficial. CDK4 amplification could possibly result inenhanced and highly active CCND1-CDK mediated cell cycle and proliferation which when targeted using CDK4/6 inhibitors could promote anti-tumor activity.

Amplification of KRAS could result in PIK3CA/MTOR or BRAF/MAPK activation, which may lead to increase in cell-proliferation and survival, which wheninhibited using PIK3CA/MEK inhibitor could prove beneficial.

The total tumor mutation burden was detected to be high at 24.15 mutations per megabase. This indicates that the patient may be a candidate for immunotherapy in an investigational setting.

First Page of Report: Expert Commentary and SummaryUltimate

Simple easy to understand report format

Expert summary, genomic highlights and response to immunotherapy given on first page

First page helps summarise the report for quick reference

All important points highlighted on the first page makes the report more meaningful

Expert Commentary helps understand the genetic basis of the disease to take more actionable clinical decisions

Genomic Highlights: Summarises the pathways driving cancer in the patient. Once pathway is identified it can be targeted.

Response to Immunotherapy: Summarises status of Tumour Mutation Burden and Microsatellite Instability


UltimateGenes Covered in PositiveSelect Ultimate

POINT MUTATIONS (>99% Sensitivity)

ABCB1

ABCC1

ABCC2

ABCC4

ABCG2

ABL1

AKT1

AKT2

AKT3

ALK

ALOX12B

AMELY

APC

AR

ARAF

ARID1A

ASXL1

ASXL2

ATM

ATR

ATRX

AURKA

AURKB

AXIN1

AXIN2

AXL

B2M

BAP1

BARD1

BBC3

BCL2

BCL2L1

BCL2L11

BCL6

BCOR

BCR

BLM

BRAF

BRCA1

BRCA2

BRD4

BRIP1

BTK

CARD11

CASP8

CBFB

CBL

CCND1

CCND2

CCND3

CCNE1

CD274

CD276

CD79B

CDC73

CDH1

CDK12

CDK4

CDK6

CDK8

ALK

FGFR2

FGFR3

RET

ROS1

NTRK1

AR

CCNE1

CCND1

CCND2

ERBB2

FGFR2

KRAS

PIK3CA

MYC

PD-L1

BRAF

CDK4

CDK6

EGFR

FGFR1

KIT

MET

PDGFRA

RAF1

ATM

APC

ARID1A

BRCA1

BRCA2

CDH1

CDKN2A

EGFR

ERBB2

GATA3

KIT

MET

MLH1

MTOR

NF1

PDGFRA

PTEN

RB1

SMAD4

STK11

TP53

TSC1

VHL

CDKN1A

CDKN1B

CDKN2A

CDKN2B

CDKN2C

CHEK1

CHEK2

CREBBP

CRKL

CRLF2

CSF1R

CTCF

CTLA4

CTNNB1

CUL3

CYP19A1

CYP1A1

CYP1A2

CYP1B1

CYP2A4

CYP2A6

CYP2B6

CYP2E1

DAXX

DAZ1

DDR2

DICER1

DIS3

DNMT1

DNMT3A

DNMT3B

DOT1L

E2F3

EGFL7

EGFR

EML4

EP300

EPCAM

EPHA3

EPHA5

EPHB1

ERBB2

ERBB3

ERBB4

ERCC2

ERCC3

ERCC4

ERCC5

ERG

ESR1

ETV1

ETV6

EWSR1

EZH2

FAM123B

FANCA

FANCC

FAT1

FBXW7

FGF19

FGF3

FGF4

FGFR1

FGFR2

FGFR3

FGFR4

FH

FLCN

FLT1

FLT3

FLT4

FOXA1

FOXL2

FOXP1

FUBP1

GATA1

GATA2

GATA3

GNA11

GNAQ

GNAS

GSK3B

GSTA1

GSTP1

HGF

HIF1A

HIST1H3B

HNF1A

HRAS

IDH1

IDH2

IFNGR1

IGF1

IGF1R

IGF2

IKBKE

IKZF1

IL10

IL7R

INSR

IRF4

IRS1

IRS2

JAK1

JAK2

JAK3

JUN

KDM5A

KDM5C

KDM5D

KDM6A

KDR

KEAP1

KIT

KLF4

KRAS

LATS1

LATS2

LMO1

MAP2K1

MAP2K2

MAP2K4

MAP3K1

MAP3K13

MAPK1

MAX

MCL1

MDC1

MDM2

MDM4

MED12

MEF2B

MEN1

MET

MITF

MLH1

MLL

MLL2

MLL3

MPL

MSH2

MSH6

MTHFD1

MTHFD1L

MTHFR

MTOR

MUTYH

MYC

MYCL1

MYCN

MYD88

MYOD1

NBN

NCOR1

NF1

NF2

NFE2L2

NKX2-1

NKX3-1

NOTCH1

NOTCH2

NOTCH3

NOTCH4

NPM1

NR1I2

NRAS

NSD1

NTRK1

NTRK2

NTRK3

NUTM1

PAK1

PAK7

PALB2

PARK2

PARP1

PAX5

PAX8

PBRM1

PDCD1

PDGFRA

PDGFRB

PDPK1

PGR

PIK3C2G

PIK3C3

PIK3CA

PIK3CB

PIK3CD

PIK3CG

PIK3R1

PIK3R2

PIK3R3

PIM1

PLK2

PMAIP1

PMS1

PMS2

PNRC1

POLE

PPP2R1A

PRDM1

PRKAR1A

PRKY

PTCH1

PTEN

PTPN11

RAC1

RAD50

RAD51

RAD51B

RAD51C

RAD51D

RAD52

RAD54L

RAF1

RARA

RASA1

RB1

RECQL4

REL

RET

RFWD2

RHOA

RICTOR

RIT1

RNF43

ROS1

RPS4Y2

RPS6KA4

RPS6KB2

RPTOR

RUNX1

RYBP

SDHA

SDHAF2

SDHB

SDHC

SDHD

SETD2

SF3B1

SH2D1A

SLC22A1

SMAD2

SMAD3

SMAD4

SMARCA4

SMARCB1

SMO

SOCS1

SOX17

SOX2

SOX9

SPOP

SRC

SRY

STAG2

STK11

STK40

SUFU

SYK

TBX3

TERT

TET1

TET2

TGFBR1

TGFBR2

TMEM127

TMPRSS2

TNFAIP3

TNFRSF14

TOP1

TP53

TP63

TRAF7

TSC1

TSC2

TSHR

TSPY4

TTTY23

TYMS

U2AF1

USP9Y

VHL

WT1

XIAP

XPO1

YAP1

YES1

ZFY


INSERTION/DELETIONS (INDELS)(>95% Sensitivity)

AMPLIFICATIONS

Ideal for aggressive/rare cancers and

patients with no treatment options

Corporate O�ce: 1st Floor Kohinoor City Mall, Gate No. 1, Kirol Road, Kurla West, Mumbai, Maharashtra, India 400070Toll Free: 1800 3070 6727 Website: www.positivebioscience.com Email: [email protected]

Ideal for patients with aggressive cancers, rare cancers and who have exhausted all treatment options

PositiveSelect can be done on blood and blocks

PositiveSelect is India’s # 1 Cancer Genomics test with every 8 out of 10 patients selecting it for deciding their treatment

PositiveSelect uses NGS, which is the New Gold standard of Molecular Diagonostics

PositiveSelect provides industry leading NGS coverage at 1000x.

PositiveSelect gives a more complete and comprehensive solution for cancer patients.

PositiveSelect is India's # 1 Cancer Genomics Test

India’s Best Selling Cancer Genomics Test · Cancer Genomics Test # 1 Precision treatment for...

Documents

Transcript of India’s Best Selling Cancer Genomics Test · Cancer Genomics Test # 1 Precision treatment for...