User:*pAmity/Sandbox

A companion diagnostic (CoDx) is a clinically validated tool that is essential for the safe and effective use of a therapy. A CoDx is a type of medical diagnostic test that has been validated with rigorous scientific experiments to show safety and efficacy and is required prior to administration of the associated therapy. The results of a CoDx inform healthcare providers regarding the suitability of a therapy for a particular patient, a strategy known as personalized medicine. Although the CoDx identifies patients that are most likely to respond to the associated treatment, the test does not guarantee a particular outcome. An example of a CoDx is the recently approved test for the BRAF V600E gene mutation that identifies patients that are most likely to benefit from vemurafenib, a biologic therapy for the most dangerous type of skin cancer, metastatic or unresectable melanoma. Another recently approved CoDx identifies the ALK gene in patients that are most likely to respond to crizotinib for metastatic non-small cell lung cancer.