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Predictive assays: Analytic validation, clinical validation and clinical utility

Predictive assays are a key element of personalized healthcare because these assays aid physicians in selecting individuals who are most likely or least likely to benefit from specific therapies. In addition to analytical validation, predictive assays require clinical validation to establish their clinical utility. Krista Acosta, Manager, CDx Pharma Services Assay Development, Nicole Schechter, PSM, PMP, CDx Director, Project Leader and Alton Yates PhD, Senior Manager, Clinical Sciences Management, will address the development and performance differences between predictive assays developed under in vitro diagnostic regulations and laboratory developed tests.
Recorded Aug 25 2016 55 mins
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Presented by
Krista Acosta, Nicole Schechter, PSM, PMP, Al Yates, PhD
Presentation preview: Predictive assays: Analytic validation, clinical validation and clinical utility

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CDx Insights
CDx Insights is a series brought to you by Roche. We are committed to providing you with educational content, from key opinion leaders, related to personalized diagnostics. We aim to ensure on ongoing conversation is taking place in this evolving area of healthcare.

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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  • Title: Predictive assays: Analytic validation, clinical validation and clinical utility
  • Live at: Aug 25 2016 4:00 pm
  • Presented by: Krista Acosta, Nicole Schechter, PSM, PMP, Al Yates, PhD
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