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 most ideal …

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 diagnostic (CDx) in …

Special Section DIA

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 between drug and …

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 now …

Sep 9, 2024 · In an era where artificial intelligence (AI) is revolutionizing healthcare and clinical research, regulatory bodies are racing to keep pace.

Clinical trials generate evidence that ultimately defines the safety and efficacy of a new medical product.

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 …

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 data from one …

As some Asia-Pacific (AP) countries (like those in ASEAN, Australia, and New Zealand) have, or are considering adoption of, regulatory reliance pathways, articulating key scientific and practical …