在FDA官網(wǎng)上的關(guān)于FDA approves Lynparza to treat advanced ovarian cancer公告顯示，BRACAnalysis CDx已經(jīng)是通過FDA批準(zhǔn)用于阿斯利康的Lynparza(olaparib)—一種與BRCA基因有關(guān)的晚期卵巢癌新藥的伴隨診斷。The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA mutations.

BRACAnalysis CDx獲FDA批準(zhǔn)用于晚期卵巢癌藥物伴隨診斷，是一種檢測(cè)卵巢癌患者全血樣本基因組的BRCA1/2基因突變的體外診斷分析系統(tǒng)。該檢測(cè)系統(tǒng)經(jīng)過Myriad genetics公司在鹽湖城實(shí)驗(yàn)室的專業(yè)驗(yàn)證，并且，臨床實(shí)驗(yàn)結(jié)果顯示該檢測(cè)可以有效鑒定卵巢癌患者的BRCA突變。

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