StrandAdvantage Tissue-Specific Cancer Genomic Tests

Empowering Crucial First-Line Therapy Decisions for Your Patient

Precision medicine in cancer refers to the delivery of personalized treatment based on the characteristics of the individual’s tumor genetics, using targeted therapies that efficiently kill tumor cells.

As advances in cancer research and drug development provide multiple treatment options, oncologists are faced with the challenging task of deciding which therapy works best for their patients. Delivering highly targeted, actionable treatment options based on the patients genetic profile, StrandAdvantage enables optimised decision making.

StrandAdvantage matches actionable cancer genes in solid tumors to all relevant, FDA-approved and NCCN recommended cancer therapies, enabling timely decisions about effective personalized therapies for patients. Strand’s NGS-based genomic profiling combined with validated molecular markers eliminates the need for multiple tests plus, provides a comprehensive view of therapy-relevant genomic and proteomic changes in an easy-to-read report.

Harness the power of precision medicine with StrandAdvantage

StrandAdvantage: Lung Carcinoma Report

StrandAdvantage provides targeted, actionable, standard-of-care treatment options in days instead of weeks

Easy-to-read report highlights the genomic alterations, and summarizes available treatment options for your patient by recommending appropriate therapies, approved by FDA or recommended by NCCN for the cancer tissue type.

Report shown for representative purposes only.

Strand Center for Genomics and Personalized Medicine

(A unit of Strand Life Sciences Pvt. Ltd.)

UAS Alumni Association Building, Veterinary College Campus, Bellary Road, Bangalore - 560024

+91-80-23095252, support.strandx@strandls.com, www.strandcenters.com

Report shown for representative purposes only.

PatientXXXXXXXXX

TRF IDSOMATIC-XX

TestStrandAdvantage Test

GenderFemale

Block IDXXXXXX

TypeSOC Report

06/10/15

10/10/15

21/10/15

Age75 years

Specimen Type FFPE Block

Date Collected

MRNNA

Specimen SiteLung

Date Received

ClinicianXXXXXXXXX

XXXXXXXXX

Date Generated

Hospital

Clinical Indications Lung adenocarcinoma

Summary for Standard Drugs

The patient does not meet the inclusion criteria for Ceritinib, Crizotinib, Vemurafenib, Dabrafenib and Trastuzumab

based on the results of this test.

Therapy

Relevant Marker

Tested Markers

Predicted Response**

GefitinibEGFR +

EGFR, KRAS, ERBB2, MET

ErlotinibEGFR +

EGFR, KRAS, ERBB2, MET

AfatinibEGFR +

EGFR, KRAS, ERBB2, MET

Bevacizumab--

KRAS, VHL

Markers for Vinorelbine, Carboplatin, Paclitaxel, Topotecan, Docetaxel, Mitomycin, Cisplatin, Doxorubicin, Etoposide, Cabozantinib,

Ifosfamide, Pemetrexed, Irinotecan, Mechlorethamine, Methotrexate, Gemcitabine, Nivolumab, Ramucirumab, Vinblastine are not part of

the StrandAdvantage SOC Report.

Enhanced Response - Better than standard population response due to the presence or absence of specific markers.

Enhanced but Limited Response - Better than standard population response mitigated by the presence of conflicting markers.

Standard Response - Expected response similar to the typical population response for the specific therapy.

Poor response - Likely poorer response or increased toxicity than the standard population response due to the presence of specific markers.

** Clinical Correlation Recommended

The Test

The StrandAdvantage Non-Small Cell Lung Carcinoma (NSCLC) test comprehensively maps actionable mutations in the tumor and matches them to appropriate FDA approved/NCCN recommended therapy regimens. The test detects low-frequency sequence variations with high sensitivity and specificity from a single biopsy sample.

Overview of StrandAdvantage Non-Small Cell Lung Carcinoma (NSCLC) Test

Erlotinib, Gefitinib, Afatinib: Most EGFR alterations indicate response to erlotinib, gefitinib and afatinib, while some mutations indicate resistance to them. Alterations in MET or KRAS may indicate poor response to erlotinib, gefitinib and afatinib. Alterations in ERBB2 indicates poor response to erlotinib and gefitinib but possible response to afatinib.

Osimertinib: Tumors with EGFR T790M mutation may respond to osimertinib.

Trastuzumab: Alterations in ERBB2 are associated with response to trastuzumab while mutations in EGFR, MET or PIK3CA are associated with poor response.

Bevacizumab: Mutations in KRAS may indicate limited response to bevacizumab while alterations in VHL indicates possible response.

Crizotinib, Ceritinib, Alectinib: ALK rearrangement indicates response to crizotinib, ceritinib, and alectinib. Alterations in MET and ROS1 rearrangement may indicate response to crizotinib.

Vemurafenib, Dabrafenib: Mutations in BRAF indicate possible response to vemurafenib and dabrafenib.

FDA Approved and NCCN Recommended Therapies Impacted by Genetic Markers

Erlotinib, Gefitinib

Afatinib

Osimertinib

Crizotinib

Ceritinib

Alectinib

EGFR, ERBB2, KRAS, MET

EGFR, ERBB2, KRAS, MET

EGFR

ALK*

ALK*

ALK*

Bevacizumab

Vemurafenib

Dabrafenib

Trastuzumab

KRAS, VHL

BRAF

BRAF

EGFR, ERBB2,MET, PIK3CA

* Measured by FISH

StrandAdvantage: Breast Carcinoma Report

StrandAdvantage provides targeted, actionable, standard-of-care treatment options in days instead of weeks

Easy-to-read report highlights the genomic alterations, and summarizes available treatment options for your patient by recommending appropriate therapies, approved by FDA or recommended by NCCN for the cancer tissue type.

standard-of-care treatment options in days instead of weeks

Easy-to-read report highlights the genomic alterations, and summarizes available treatment options for your patient by recommending appropriate therapies, approved by FDA or recommended by NCCN for the cancer tissue type.

Report shown for representative purposes only.

Strand Center for Genomics and Personalized Medicine

(A unit of Strand Life Sciences Pvt. Ltd.)

UAS Alumni Association Building, Veterinary College Campus, Bellary Road, Bangalore - 560024

+91-80-23095252, support.strandx@strandls.com, www.strandcenters.com

PatientSTRAN-xxx

TRF IDSOMATIC-xx

TestStrandAdvantage Test

GenderFemale

Block IDXXXXXX

TypeSOC Report

AgeNot Available

NA

Specimen Type FFPE DNA

Sample Collected 08/10/15

11/10/15

22/10/15

MRN

Specimen SiteBreast

Sample Received

ClinicianXXXXXXXXXX

Report Generated

HospitalXXXXXXXXXXX

Clinical Indications Breast carcinoma (ER+ve/PR+ve/HER2-ve)

Summary for Standard Drugs

The patient does not meet the inclusion criteria for Lapatinib, Pertuzumab and Trastuzumab based on the results of

this test.

Therapy

Relevant Marker

Tested Markers

Predicted Response**

EpirubicinTOP2A IHC +

PgP, TOP2A

DoxorubicinTOP2A IHC +

PgP, TOP2A

EverolimusPTEN +

HER2, ER, PIK3CA, PTEN

TamoxifenER IHC +

EGFR, HER2, ER, ERBB2

Bevacizumab--

VHL

Palbociclib--

HER2, ER

DocetaxelTUBB3 IHC +

PgP, TUBB3

PaclitaxelTUBB3 IHC +

PgP, TUBB3

FluorouracilTS IHC +

SMAD4, TS

Markers for Exemestane, Toremifene, Carboplatin, Goserelin, Fulvestrant, Letrozole, Anastrozole, Capecitabine, Ixabepilone, Cisplatin,

Cyclophosphamide, Megestrol, Methotrexate, Gemcitabine, Thiotepa, Vinblastine, Eribulin are not part of the StrandAdvantage SOC Report.

Enhanced Response - Better than standard population response due to the presence or absence of specific markers.

Enhanced but Limited Response - Better than standard population response mitigated by the presence of conflicting markers.

Standard Response - Expected response similar to the typical population response for the specific therapy.

Poor response - Likely poorer response or increased toxicity than the standard population response due to the presence of specific markers.

Everolimus: In ER positive, HER2 negative breast cancer, mutations in PIK3CA or loss of PTEN expression or function may indicate enhanced response to everolimus.

Tamoxifen: In ER positive breast cancer, alterations in EGFR and ERBB2, and high levels of HER2 may indicate poor response to tamoxifen.

Bevacizumab: Loss of VHL may indicate response to bevacizumab.

5-fluorouracil: Loss of SMAD4 and high levels of TS indicate poor response to 5-fluorouracil-based therapy, where as low levels of TS indicate response.

Paclitaxel, Docetaxel: High levels of Pgp and TUBB3 indicate poor response to paclitaxel and docetaxel.

Doxorubicin, Epirubicin: High levels of TOP2A indicate response to doxorubicin and epirubicin indicates response to doxorubicin and epirubicin. High levels of Pgp indicate poor response to doxorubicin and epirubicin.

Trastuzumab, Pertuzumab, Lapatinib: Alterations in ERBB2 indicate response to anti-HER2 therapy such as trastuzumab, pertuzumab and lapatinib. In HER2 positive breast cancers, mutation in PIK3CA, alterations in EGFR or low levels of PTEN indicate poor response to trastuzumab and pertuzumab.

The Test

The StrandAdvantage Breast Carcinoma test comprehensively maps actionable mutations in the tumor and matches them to appropriate FDA approved/NCCN recommended therapy regimens. The test detects low-frequency sequence variations with high sensitivity and specificity from a single biopsy sample. The test also includes IHC (immunohistochemistry) to assess the expression level and cellular localization of specific markers. These markers have been selected based on their therapeutic significance.

Overview of StrandAdvantage Breast Carcinoma Test

FDA Approved and NCCN Recommended Therapies Impacted by Genetic Markers

Everolimus

Doxorubicin,Epirubicin

5-fluorouracil

Bevacizumab

ER*, HER2*, PIK3CA, PTEN*

Pgp*, TOP2A*

SMAD4, TS*

VHL

Lapatinib

Trastuzumab

Pertuzumab

Paclitaxel, Docetaxel

Tamoxifen

ERBB2/HER2*, PIK3CA

EGFR, ERBB2/HER2*, PIK3CA, PTEN

EGFR, ERBB2/HER2*, PIK3CA, PTEN

Pgp*, TUBB3*

ER*, ERBB2/HER2*, EGFR

* Indicates IHC markers

StrandAdvantage: Colorectal Carcinoma Report

StrandAdvantage provides targeted, actionable, standard-of-care treatment options in days instead of weeks

Report shown for representative purposes only.

Easy-to-read report highlights the genomic alterations, and summarizes available treatment options for your patient by recommending appropriate therapies, approved by FDA or recommended by NCCN for the cancer tissue type.

Strand Center for Genomics and Personalized Medicine

(A unit of Strand Life Sciences Pvt. Ltd.)

UAS Alumni Association Building, Veterinary College Campus, Bellary Road, Bangalore - 560024

+91-80-23095252, support.strandx@strandls.com, www.strandcenters.com

Report shown for representative purposes only.

PatientXXX

TRF IDSOMATIC-

XXXXXX

XXXXXX

XXXXXX

XX

TestStrandAdvantage Test

GenderMale

Block ID

TypeSOC Report

02/12/15

06/12/15

16/12/15

Age40 years

Specimen Type FFPE Block

Sample Collected

MRNNA

Specimen SiteColon

Sample Received

Clinician

Report Generated

Hospital

Clinical Indications Colorectal cancer

Summary for Standard Drugs

Therapy

Relevant Marker

Tested Markers

Predicted Response**

OxaliplatinKRAS +

KRAS

Fluorouracil--

SMAD4, APC

BevacizumabKRAS +

KRAS

PanitumumabKRAS +

EGFR, NRAS, KRAS, BRAF, MET, PIK3CA,

PTEN

CetuximabKRAS +

EGFR, NRAS, KRAS, BRAF, MET, PIK3CA,

PTEN

Markers for Capecitabine, Ziv-Aflibercept, Irinotecan, Leucovorin, Regorafenib are not part of the StrandAdvantage SOC Report.

Enhanced Response - Better than standard population response due to the presence or absence of specific markers.

Enhanced but Limited Response - Better than standard population response mitigated by the presence of conflicting markers.

Standard Response - Expected response similar to the typical population response for the specific therapy.

Poor response - Likely poorer response or increased toxicity than the standard population response due to the presence of specific markers.

** Clinical Correlation Recommended

The Test

The StrandAdvantage Colorectal Carcinoma test comprehensively maps actionable mutations in the tumor and matches them to appropriate FDA approved/NCCN recommended therapy regimens. The test detects low-frequency sequence variations with high sensitivity and specificity from a single biopsy sample.

Overview of Colorectal Carcinoma Test

Cetuximab, Panitumumab: Mutations in KRAS or NRAS indicate poor response to cetuximab and panitumumab while wild type status of these genes indicates favorable response. Additionally, alterations in BRAF, MET, PTEN or PIK3CA may indicate poor response. Alterations in EGFR may indicate favourable response to cetuximab and panitumumab in the absence of alterations in the above genes.

Bevacizumab: Mutations in KRAS may indicate limited response to bevacizumab.

5-fluorouracil: Loss of APC and SMAD4 may indicate poor response to 5-fluorouracil.

Oxaliplatin: Mutations in KRAS indicate possible response to oxaliplatin.

FDA Approved and NCCN Recommended TherapiesImpacted by Genetic Markers

5-fluorouracil

Cetuximab

Panitumumab

Oxaliplatin

Bevacizumab

APC, SMAD4

BRAF, EGFR, KRAS, MET,NRAS, PIK3CA, PTEN

BRAF, EGFR, KRAS, MET,NRAS, PIK3CA, PTEN

KRAS

KRAS

Why Strand

StrandAdvantage offers oncologists and pathologists a powerful new tool to determine optimal therapeutic strategies for cancer patients and start treatments quickly.

StrandAdvantage is designed for oncologists to use as a resource when making first-line decisions

Standard-of-care gene profile results are delivered in ten working days.

Best-in-class interpretation and reporting

Expert Interpretation and reporting using proprietary technology with deep curation and interpretation conducted by a very large team of expert scientists.

Easy-to-read reports.

Comprehensive view of treatment options

Strand’s comprehensive database of genomic variants links to FDA-approved and NCCN recommended targeted cancer therapies.

Clinical Utility of StrandAdvantageStrandAdvantage Test Performance Characteristics

Validation Summary

Graph denotes percentage of cases where clinically actionable variation(s) were reported

100

75

50

25

0LUNG BREAST COLON

*Slightly lower specificity and concordance can be explained by the limitation of Sanger to detect SNPs at <30% supporting reads. Validation performed by Sanger sequencing.

*Clinical utility and assay validation parameters are only applicable to the gene loci sequenced by NGS

66% 67%

78%

Assay Validation Parameter Results

Assay Accuracy / concordance 95.8%

Analytical sensitivity 100%

Analytical specificity 95%

Reproducibility 99.7%

Affordability

StrandAdvantage provides an affordable opportunity to obtain faster and more actionable results compared to other tests.

Chemotherapeutic Response StrandAdvantage provides information related to

chemotherapeutic response for use in standard-of-care setting. StrandAdvantage provides extensively curated information from the literature on the genetic basis of chemotherapy response and identifies markers that are linked specifically to chemotherapy sensitivity, response or toxicity.

Optimized to fit the needs of clinical practice, StrandAdvantage uses next-generation sequencing to analyze cancer-related genes taken from solid tumor samples. The test results are annotated using a comprehensive knowledge base curated by proprietary technology and an experienced team of scientists at Strand.

The StrandAdvantage Testing Process

From Prescription to Report

Test Prescription

Provide prescription to your patient for StrandAdvantage testing.

Sample collection

The hospital or our product specialist collects sample from patient in kits provided by us. Sample is sent to our lab for processing.

Sample processing & analysis

Samples are processed through state-of-the art analysis, interpretation, and reporting platforms by our team of expert scientists.

Report

Receive your clinical report securely through email. The final results are delivered in an easy-to-read report containing actionable genomic variant information. Our clinical experts are available to help you review the results and answer any questions you may have.

StrandAdvantage Lung, Breast, Colon Cancer Tests – 10 working days Complete 48 gene report – 4 weeks

Turnaround Time (TAT) for StrandAdvantage Test

Sample Requirement to Perform StrandAdvantage Test

Formalin-fixed, paraffin embedded tissue (FFPE)

MSI

ATGCATGC

Cytogenetics

FISH

Single gene

ATGCATGCATGATGCATGCATGCATGCATGCATGACATGCATGCATGAATGCATGCATGATGCATGCATGCATGCATGCATGACATGCATGCATGAATGCATGCATGATGCATGCATGCATGCATGCATGACATGCATGCATGA

Biopsy ResectionSpecimen

NGStargeted panels

IHC

“The StrandAdvantagetest indicates that your

tumor contains actionable mutations which uniquely

qualifies you for an alternate targeted drug

therapy.”

Over the years, rapid advances in cancer diagnostic technology has enabled oncologists to obtain deeper

insights about the patients tumor and genetics, thereby helping make informed and actionable

therapy decisions for them.

“We tested your tumor sample and looked at it under the microscope. The morphology of the

tumor suggests the tumor may be of subtype X.”

tumor suggests the tumor

Oncologists change in approach to cancer diagnosis

and

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apy

sele

ctio

n

Evolution of Cancer DiagnosticsCancer DiagnosticsCancer Diagnostics

Evolution of Evolution of Evolution of Evolution of Evolution of Evolution of Evolution of Cancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer DiagnosticsCancer Diagnostics

Short TAT to start therapy, including first-line options.

Testing of many genes concurrently (simultaneous identification of a driver mutation, as well as a secondary mutation in the gene).

Identification of resistance to targeted therapy for the driver gene, thus helping predict the contraindications of a targeted drug.

Targeting tumors of different origins with the same driver mutations, using a single drug.

Testing a tumor for mutations and genes other than the ones typically associated with that tumor for more information.

Determining with very high sensitivity extremely subtle mutations that are unique to the tumor.

Capturing tumor heterogeneity with high sensitivity, often missed with other molecular testing approaches.

Compared to single gene testing approaches, Strand’s NGS-based multi-gene testing allows :

Benefits of Using Strand’s NGS-Based Multi-Gene Tests vs. Single Gene Tests

Histopathology

Patients with solid tumors, especially those with breast, lung, and colon cancers for whom individual, tissue specific panels are available.

Prior to starting therapy, as part of your molecular work-up.

Patients who have failed first-line therapy, or have a metastatic presentation.

During the neoadjuvant period and soon after surgery.

For Which of My Patients Should I Order the StrandAdvantage Test?

About StrandA History of Innovative Genomic Research

Founded in 2000, Strand Life Sciences is a personalized medicine company offering next-generation sequencing (NGS)-based, targeted multi-gene panels for cancer and other diseases. Strand works with oncologists, pathologists, and community hospitals to enable faster clinical decision support for accurate molecular diagnosis, prognosis, therapy recommendations, and clinical trials. Strand’s central reference laboratories are located in Bangalore, India and Colorado, USA. For larger hospital systems, Strand offers an innovative customizable turnkey solution called Strand SmartLab (www.strandcenters.com). Our genomics products and solutions are used at over 2,000 laboratories and 100 hospitals worldwide.

www.strandls.com

A Trusted Partner to Companies WorldwideFor 15 years, our products have facilitated the work of leading researchers and medical geneticists around the world.

Contact UsGet started with targeted cancer treatments. Order a test kit today or talk to one of our product specialists to learn more.

Strand Center for Genomics & Personalized Medicine (A unit of Strand Life Sciences Pvt. Ltd.) UAS Alumni Association Building, Veterinary College Campus, Bellary Road, Hebbal, Bangalore – 560 024 Phone: +91-80-2309-5252, support.strandx@strandls.com, www.strandcenters.com

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