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A companion diagnostic (CDx) [1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. [2]Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.
The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) as a companion diagnostic for the selection of patients with pancreatic cancer for treatment with olaparib based upon the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes. [31]
Alpelisib is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
The Food and Drug Administration (FDA) has recently approved a blood test screening for colorectal cancer that has an over 83% success rate at detecting the presence of this form of cancer.
Under the government's plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be FDA approved within 3 1/2 years. Lower risks tests ...
The approval allows the use of the cancer drug, Rybrevant, in combination with J&J's existing drug, lazertinib, as a first-line treatment for non-small cell lung cancer (NSCLC) patients with a ...