Tissue Diagnostics Driving personalised healthcare

Introduction

What is tissue diagnostics?

Driving personalised healthcare

Continuing to innovate tissue diagnostics

In-vitro diagnostics Healthcare’s unsung hero

Improve patients' lives:

•  Influencing over 60% of critical healthcare decision-making1

•  Estimated to contribute up to 94% of the objective data in clinical records1

IVD < 2% total worldwide healthcare spending

Alleviating healthcare costs:

•  Accounting for less than 2% of worldwide healthcare spending1

•  Diagnostic tests can help address healthcare cost burden through disease prevention and enabling physicians to make timely and appropriate clinical decisions1

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Introduction

What is tissue diagnostics?

Driving personalised healthcare

Continuing to innovate tissue diagnostics

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Tissue-based diagnostic testing continues to serve as one of the gold standards for cancer diagnosis. There is no other technology that can capture the biological context of the disease and the critical parameters that factor into patient outcomes.2

– Kalorama Information

What is tissue-based diagnostic testing?

Histopathology: study of disease in tissue

Specimens usually consist of pieces of tissue in various sizes, obtained by various methods. These may include:

•  Small biopsies (such as gastric, breast, kidney, prostate, liver, cardiac and skin)

•  Lavage and fine needle aspirates for lung cancer

•  Larger specimens removed at surgery

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Tissue diagnostics process

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Tissue preparation

Tissue staining and testing

Result interpretation

What are three major tissue diagnostics tests?

•  Hematoxylin & Eosin (H&E) is the most widely used stain in medical diagnosis, highlighting structures in tissue for evaluation

•  Immunohistochemistry (IHC) is the process of using antibodies to stain particular proteins; greatly increases the ability to identify categories of cells

•  In situ hybridization (ISH) is an advanced technique to identify specific DNA or RNA molecules

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•  Shape of tumour

•  Size of tumour

•  Location of cancer cells with tumour

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Tissue morphology: what does it tell us?

Genetic information in morphological context Tissue enables personalised diagnosis & treatment

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We push beyond the patient’s traditional QUESTIONS:

•  Do I have cancer? •  Is there a treatment? •  Will I live?

Breaking new boundaries, we enable deeper ANSWERS:

•  What kind of cancer do I have? •  What is the best treatment

•  What about my family?

Tissue diagnostics & market growth

•  Tissue testing led a $28 billion personalized medicine testing market in 20113

•  Tissue tests will lead IVD industry revenue growth in the next five years3

•  Diagnostics provide potential revenue & knowledge capital to stratify patients & define targeted patient populations3

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Introduction

What is tissue diagnostics?

Driving personalised healthcare

Continuing to innovate tissue diagnostics

Tissue diagnostics & pharma

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Diagnostic tools have a wide array of applications but are specifically involved in stratifying patients and identifying development opportunities for therapeutic products. Pharma’s role is to develop products to treat those patients. Collaborations between these two industries seem like a match made in heaven.5

– Scienta Advisors Blog

Personalised Healthcare

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Targeted therapy

Companion Diagnostics

Roche diagnostics driving PHC Creating medical value through new diagnostic tests

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Diagnostics

Companion Diagnostics

•  Screening •  Diagnosis •  Prognosis

•  Prediction • Monitoring

•  Treatment selection •  Response prediction •  Treatment monitoring

Medical Value

Tissue diagnostics & personalised healthcare Valuing the individual

Companion diagnostics

•  Improving patient survival rates, therapies in oncology are being combined with predictive biomarkers to help select patients who will or will not respond to specific drugs3

Targeted treatment

•  Tissue tests that determine the best course of therapy make personalised healthcare a reality

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INFORM HER2 Dual ISH DNA Probe Cocktail Companion diagnostic for breast cancer

•  Fully automated brightfield microscope assay to assess HER2 gene status with morphological context

•  Intra-tumor heterogeneity is more easily identified with brightfield technology

•  Gene status determines eligibility for personalised treatment with HerceptinTM – a targeted therapy that can significantly improve outcomes for qualified patients

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Introduction

What is tissue diagnostics?

Driving personalised healthcare

Continuing to innovate tissue diagnostics

Roche innovates tissue diagnostics We bring you a series of “firsts” in cancer care

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Change the practice of medicine by inventing tools that didn’t exist before, rather than building a better microscope. – omas Grogan, MD, Founder, Ventana Medical Systems, Inc.

Tissue diagnostics & testing efficiency

•  As cancer incidence rates increase, labs will need to improve efficiencies to manage test volumes

•  Fully automated, integrated slide staining and workflow tracking systems help labs manage higher test volumes with fewer resources

•  Highly efficient testing can mean cost savings for labs and faster results for patients

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Automation and standardisation maximizes patient safety

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•  Individual slide staining helps protect against tissue cross contamination & patient misdiagnosis

•  Slide barcoding helps prevent labeling errors & patient misidentification

•  Single piece flow and barcode tracking, for chain of custody

Tissue diagnostics innovation Empowering the anatomical pathology laboratory

1st fully automated IHC, ISH & FISH staining technologies BenchMark series IHC/ISH lab automation improves efficiency & quality

1st fully automated H&E SYMPHONY individual slide staining platform for H&E helps prevent cross contamination

1st workflow management system of its kind VANTAGE workflow management system allows for a lab-wide chain of custody

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Tissue diagnostics innovation Changing the practice of medicine

1st FDA-approved HER2 Dual ISH brightfield technology Qualifies patients for HerceptinTM therapy, a drug that can significantly improve outcomes

1st IVD IHC BRAF antibody Empowers pathologists to evaluate the BRAF V600E mutation at the single-cell level

1st HER2 FDA 510(K) cleared algorithm Enables consistent scoring of breast tumours

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Improving the global standard of care One patient at a time

•  11,000 fully automated instruments installed worldwide

•  3,000 pathology laboratories worldwide empowered through Roche automation & assays

•  37.3 million slides processed individually & barcoded for positive patient ID (2012)

•  8 million patients’ lives touched by safer, more efficient lab processes in 2011 alone

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Creativity is courageous Roche: a culture of continuous innovation

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There is no innovation without taking risks. This is the nature of innovation. If we are afraid to fail, we should not be in this business. By definition, we need a lot of courage. This is not a business for cowards. – Severin Schwann, Roche CEO

References

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1.  Debnath, Mousumi, Bisen, Prakash S. and Prasad, Godavarthi B.K.S. Molecular Diagnostics: Promises and Possibilities. Springer. 2010, XVIII, 508p.

2.  Tissue Diagnostics Leads Personalized Medicine: Kalorama. Kalorama Information. March 7, 2012. http://www.kaloramainformation.com/about/release.asp?id=2642 Accessed July 8, 2013.

3.  Monegain, Bernie. Personalized medicine market in growth mode. Healthcare IT News. March 8, 2012. http://www.healthcareitnews.com/news/personalized-medicine-market-growth-mode Accessed July 8, 2013.

4.  Kulkarani, S. and Ma, P Personalized Medicine: The Path Forward. McKinsey & Company. March 2013. http://www.mckinsey.com/client_service/pharmaceuticals_and_medical_products Accessed July 8, 2013.

5.  Dilwali, Prashant. Was 2010 the Engagement Year Between Pharmaceutical and Diagnostic Companies? Scientia Advisors Blog. January 11, 2011. http://www.scientiaadv.com/blog/2011/01/11/was-2010-the-engagement-year-between-pharmaceutical-and-diagnostic-companies/ Accessed July 7, 2013.

6.  Tailor-made Cancer Treatment for Men and Women; Results may be better outcomes and less side effects. Cleveland Clinic. Cancer Care Team. February 20, 2013. http://health.clevelandclinic.org/2013/02/tailor-made-cancer-treatment-for-men-and-women/

Doing now what patients need next