羅氏分子診斷 再捷報! cobas(R) KRAS 基因檢測指導 轉移腸癌用藥(Erbitux(R) (cetuximab)/ Vectibix(R) (panitumumab))

羅氏cobas KRAS基因突變測試獲得FDA批准 2015-05-12 03:22 加州普萊森頓, 2015年5月11日 /美通社-PR Newswire/ -- 羅氏（Roche，SIX: RO, ROG; OTCQX: RHHBY）今天宣佈，用於診斷的cobasR KRAS基因突變測試獲得了美國食品藥品監督管理局（U.S. Food and Drug Administration，簡稱FDA）的批准。設計該即時聚合 鏈式反應(PCR)測試的目的是，發現轉移性結直腸癌(mCRC)患者腫瘤樣本中的KRAS基因突變，並幫助臨床醫生為這類患者確定治療路徑。 羅氏分子診斷部門負責人Paul Brown表示：「鑒於癌症患者現在擁有靶向性更強的治療選擇方案，鑒別正確的分子資訊來確定患者的疾病的價值就變得非常重要。cobasR KRAS基因突變測試能夠為臨床醫生提供可付諸行動的資訊分析，這支援臨床醫生為患者做出明智的治療決策。在此次獲得FDA批准後，羅氏現在能夠在美國為腫瘤治療提供最為全面並獲得FDA批准的伴隨診斷組合，包括BRAF（黑素瘤）、EGFR（肺癌）和KRAS（轉移性結直腸癌）基因變異方面的測試。」 美國疾病控制與預防中心(Centers for Disease Control and Prevention)資料顯示，結直腸癌是美國第二大引起癌症相關死亡的原因，也是男性和女性人群中第三種最常見的癌症。cobasR KRAS基因突變測試旨在用於幫助鑒別轉移性結直腸癌患者，而在KRAS基因突變沒出現的情況下，結合愛必妥(ErbituxR)（西妥昔單抗）或VectibixR（帕尼單抗）進行治療可能會對轉移性結直腸癌患者起到效果。 cobasR KRAS基因突變測試開展時間不到八個小時，醫生們可以由此快速自信地做出治療決策。 消息來源 羅氏

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the cobas® KRAS Mutation Test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them. "As more targeted treatment options for cancer patients become available, the importance of identifying the right molecular information to define their disease becomes critical," said Paul Brown, Head of Roche Molecular Diagnostics. "The cobas® KRAS Mutation Test gives clinicians actionable insights that enable them to make informed decisions about treatment for their patient. With this approval, Roche now offers the most comprehensive companion diagnostic FDA approved portfolio for oncology in the U.S., including tests for BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations." According to the Centers for Disease Control and Prevention, colorectal cancer is the second leading cause of cancer-related deaths in the United States and the third most common cancer in men and women. The cobas® KRAS Mutation Test is intended to be used as an aid in the identification of mCRC patients for whom treatment with Erbitux® (cetuximab) or Vectibix® (panitumumab) may be effective if no KRAS mutation is present.