Value of Tissue Diagnostics, Driving Personalised Healthcare


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Tissue diagnostic testing provides biological context that can factor into patient outcomes. Supported by facts and statistics from respected sources, this brief educational presentation demonstrates the medical value that tissue diagnostics bring to the practice of medicine. In a rapidly evolving world of diagnostic technologies, tissue-based testing performed in the histology laboratory remains a gold standard for cancer diagnosis.

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Value of Tissue Diagnostics, Driving Personalised Healthcare

  1. 1. Tissue Diagnostics Driving personalised healthcare
  2. 2. Introduction What is tissue diagnostics? Driving personalised healthcare Continuing to innovate tissue diagnostics
  3. 3. 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 3
  4. 4. Introduction What is tissue diagnostics? Driving personalised healthcare Continuing to innovate tissue diagnostics
  5. 5. 5 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
  6. 6. 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 6
  7. 7. Tissue diagnostics process 7 Tissue preparation Tissue staining and testing Result interpretation
  8. 8. 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 8
  9. 9. •  Shape of tumour •  Size of tumour •  Location of cancer cells with tumour 9 Tissue morphology: what does it tell us?
  10. 10. Genetic information in morphological context Tissue enables personalised diagnosis & treatment 10 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?
  11. 11. 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 11
  12. 12. Introduction What is tissue diagnostics? Driving personalised healthcare Continuing to innovate tissue diagnostics
  13. 13. Tissue diagnostics & pharma 13 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
  14. 14. Personalised Healthcare 14 Targeted therapy Companion Diagnostics
  15. 15. Roche diagnostics driving PHC Creating medical value through new diagnostic tests 15 Diagnostics Companion Diagnostics •  Screening •  Diagnosis •  Prognosis •  Prediction •  Monitoring •  Treatment selection •  Response prediction •  Treatment monitoring Medical Value
  16. 16. 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 16
  17. 17. 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 17
  18. 18. Introduction What is tissue diagnostics? Driving personalised healthcare Continuing to innovate tissue diagnostics
  19. 19. Roche innovates tissue diagnostics We bring you a series of “firsts” in cancer care 19 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.
  20. 20. 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 20
  21. 21. Automation and standardisation maximizes patient safety 21 •  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
  22. 22. 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 22
  23. 23. 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 23
  24. 24. 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 24
  25. 25. Creativity is courageous Roche: a culture of continuous innovation 25 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
  26. 26. References 26 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. Accessed July 8, 2013. 3.  Monegain, Bernie. Personalized medicine market in growth mode. Healthcare IT News. March 8, 2012. Accessed July 8, 2013. 4.  Kulkarani, S. and Ma, P Personalized Medicine: The Path Forward. McKinsey & Company. March 2013. Accessed July 8, 2013. 5.  Dilwali, Prashant. Was 2010 the Engagement Year Between Pharmaceutical and Diagnostic Companies? Scientia Advisors Blog. January 11, 2011. 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.
  27. 27. Doing now what patients need next