Integrated Medicines Ltd, Director of Programmes, Topfield House, Ermine Street, Caxton, Cambridge, CB23 3PQ, UK.
Expert Rev Mol Diagn. 2012 Jul;12(6):561-3. doi: 10.1586/erm.12.49.
This article summarizes the broad messages from pharmaceutical and diagnostic companies on the collaborations required to support companion diagnostics. Since the groundbreaking herceptin HER2 diagnostic model in 1998, it has taken until 2011 for the US FDA to issue a draft guidance document, which was then immediately followed with approvals for two new drugs and their companion diagnostics. This conference summarized the current state of thinking in new projects and innovative technologies in pharmaceutical and diagnostic codevelopment. Attitudes are slowly changing and collaborations are rapidly ensuing, although the alignment between pharmaceutical and diagnostic understanding of value, timelines, outcomes and impact is difficult and remains a contentious area. The value of this conference has been to address these issues.
本文总结了制药和诊断公司在支持伴随诊断所需合作方面的广泛信息。自 1998 年开创性的曲妥珠单抗 HER2 诊断模型以来，直到 2011 年美国 FDA 才发布了一份指导草案，随后立即批准了两种新药及其伴随诊断。本次会议总结了制药和诊断联合开发中新项目和创新技术的当前思维状态。态度正在缓慢转变，合作正在迅速展开，尽管制药和诊断对价值、时间、结果和影响的理解存在差异，并且这仍然是一个有争议的领域。本次会议的价值在于解决这些问题。
