Please read Dr. Cooper’s article in the Therapeutic Innovation & Regulatory Science titled, “Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups.“
Personalized medicine, now commonly referred to as precision medicine, involves the use of genetic or biomarker information for making treatment decisions. In oncology, traditional approaches in product development and patient treatment decisions were driven by tumor histology, disease stage, and line of therapy; however, recent advanced understanding of the molecular pathology of the disease has progressed the development of drugs whose mechanism of action targets specific genomic alterations. These molecular characteristics are linked to the treatment outcomes or predicted therapeutic effects of the product. To ensure use of the targeted therapy in only those patients who are expected to benefit, an in vitro companion diagnostic (CDx) is used to identify the existence or absence of the desired marker. To date, such CDx devices have included immunohistochemistry (IHC) tests, polymerase chain reaction (PCR), in situ hybridization (ISH) devices such as FISH and CISH, as well as other DNA sequencing devices. To read the full article.
Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups. Cooper L, Chen J. Ther Innov Regul Sci. 2022 Jun 10. PMID: 35689144 DOI: 10.1007/s43441-022-00422-z Online ahead of print.