Development of companion diagnostics (CDx) as powerful tools in precision medicine typically follows one of three pathways: co-development, bridging, and follow-on. Co-development is …

The Current Status for HER2 Testing There is a large portfolio of available human epidermal growth factor receptor 2 (HER2)-targeted therapies that have an associated companion …

Jul 1, 2022 · As these national guidelines and regulations continue to create favorable conditions for development of drug-CDx reagents in China, industry has responded with calls for China’s …

Integral to PM are companion diagnostics (CDx), devices designed and developed to select the right patient candidates for the precision drug. Inevitably, this codependent relationship …

ulti-Regional Clinical Trials (MRCT) is not a new term and has been in use for many decades. It refers to a clinical trial conducted in more than one region under a single protocol and allows …

Integral to PM are companion diagnostics (CDx), devices designed and developed to select the right patient candidates for the precision drug. Inevitably, this codependent relationship …

Co-development is the most ideal and cost-effective CDx pathway: It is conducive to screening target patients specifically and identifying drug targets accurately, reducing development cost …

However, developing tests with rigorously validated clinical utility can be challenging from an evidence generation perspective, as well as in attaining consensus among patients, …

Companion diagnostics are a class of diagnostic devices that has become important not only in personalizing therapy for patients, but also for developers of therapeutic products, who must …