DAKO has gotten the approval of a new HER2 diagnostic test by FDA.
Already, DAKO has gotten the traditional immunohistchemical diagnostic test named HercepTest.
This is a major kit to decide the Herceptin treatment for HER2 positive breast cancer patients.
However, if the staining is weak, an additional test is needed. That is FISH test.
About FISH test, Abbott is a famous provider of it and DAKO didn't have a line-up for FISH test.
CISH test is able to diagnose the HER2 gene's multiplication as same as FISH test.
Therefore, DAKO was able to get the both diagnostic tests according to this approval.
HER2 CISH PharmDxは、HER2ステータスを診断する検査方法の一つ、CISH（Chromogenic in situ Hybridization）法を用いるものだ。
HER2遺伝子検査HER2 CISH PharmDxがFDAに承認：日経メディカル
HER2遺伝子に対する標準検査法である蛍光in situハイブリダイゼーション（FISH）法は、蛍光色素を用いて染色体分析を行うため、特殊な蛍光顕微鏡を必要とする。それに対し、CISH法では発色色素を用いて可視化させるため、通常の光学顕微鏡下で検出可能となる利点がある。
This new shows that CISH is easier than FISH.
If the standardization of CISH is established, this approval would give the hope to the BC patients.
