Roundtable will address CDx development strategies in light of changing European IVD regulations
24/04/2018 — AUSTIN, Texas — (BUSINESS WIRE)
Asuragen, Inc., a molecular diagnostics company delivering easy to use products for complex testing in genetics and oncology, announced that its senior vice president of commercial operations, Colin Hill, will chair a roundtable discussion during the 2018 World Clinical Biomarkers & Companion Diagnostic (CB & CDx) Europe Summit taking place May 1-3 in London, UK. The session will focus on the imminent changes to the regulatory environment in Europe and the implications for pharmaceutical and diagnostic companies collaborating to advance precision medicine.
“Precision medicine is becoming a reality around the world, and the regulations that guide it are rapidly evolving,” said Hill. “It is essential that we build close collaboration between the pharmaceutical, medical device and in vitro diagnostics industry if we are going to successfully navigate this new environment. While our success will definitely leverage learnings from the US experience, we will have to broaden our thinking as we deal with some of the inherent differences in the healthcare delivery model(s) between the US and Europe.”
The roundtable discussion, titled “The Rx-Dx Paradigm and Ensuring Continued CDx Development with Appropriate Risk and Reward,” is part of the Drug-Dx Commercialisation Stream and will occur at 16.30 on Wednesday, May 2. The discussion will highlight several topical issues facing both the pharmaceutical and diagnostic industries, including addressing value share imbalances between these industries, streamlining the collaboration process from concept to commercialization, and understanding the specific nuances of the European market to ensure mutual successes.
Asuragen is a molecular diagnostic company changing the way patients are treated in genetics and oncology. The quality, simplicity and sensitivity of its products brings precision medicine within reach. Asuragen’s diagnostic systems, composed of proprietary chemistry and software, deliver powerful answers using broadly installed instrument platforms. They are simple to adopt and expand the ability to serve patients. Asuragen is a product foundry rapidly and efficiently addressing current and emerging clinical needs, including cancer diagnosis and monitoring, reproductive health and aging, serving laboratories across a patient’s lifespan with its best in class diagnostic tests. For more information, visit www.asuragen.com.
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