New Xtalks Webinar to Address the Increasing Demand for Single-Site Pre-Market Approval Models in the Pursuit of Companion Diagnostic Development (CDx)

New Xtalks Webinar to Address the Increasing Demand for Single-Site Pre-Market Approval Models in the Pursuit of Companion Diagnostic Development (CDx)

Press Release ( - Toronto, Canada - Mar 06, 2018 - Join esteemed speakers from Covance including Steven Anderson, PhD, Senior Vice President and Chief Scientific Officer, and Tom Turi, PhD, Vice President of Companion Diagnostics for a live session on Wednesday, March 21, 2018 at 11 a.m. EDT (3 p.m. GMT),

The Laboratory Developed Test (LDT) approach, incorporating the single-site pre-market approval, for Companion Diagnostic development has seen a recent increase in interest because of the evolving regulatory and business environment. In a precision medicine approach to drug development there is great uncertainty at the beginning of a program as to whether it will produce a viable companion diagnostic; the benefits of flexibility, faster results, reduced upfront investment and effective risk management make the single-site pre-market approval path an increasingly appealing option. If a successful CDx candidate does emerge, the development can bridge to an in vitro diagnostic (IVD) approach, enabling global distribution.

Specifically, you will learn:

  • How to assess the appropriateness of a single-site pre-market approval approach
  • Regulatory considerations for design and validation of the CDx assay
  • Speed to commercialization benefits through a single-site pre-market approval approach
  • How and when to most effectively engage a CRO / lab partner in the process

Please join us for an insightful discussion – and answers to your questions – on these clinically and commercially relevant topics.

The webinar will benefit senior professionals involved in research and development, personalized medicine, biomarker development, targeted therapeutics, molecular oncology, clinical pharmacology, medical/regulatory affairs, translational medicine, companion diagnostics and preclinical or clinical outsourcing.

For more information about this complimentary event, visit: Flexible, Fast, Efficient: The Expanding Role of Single-Site Pre-Market Approval in Companion Diagnostics Development.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit

For information about hosting a webinar visit


Nima Rajan

Tel: +1 (416) 977-6555 ext 352


Source : Xtalks
Business Info :


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