Agilent HER2 IQFISH pharmDx

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

제공처:

AGILENT TECHNOLOGIES SINGAPORE (INTERNATIONAL) PTE LTD

수업:

Class C IVD

Manufactured by:

Agilent Technologies Singapore (International) Pte Ltd

치료 영역:

Gastroenterology & Urology

치료 징후:

HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with adenocarcinoma of the stomach including gastro-esophageal junction. HER2 IQFISH pharmDx is indicated in adjunction to HercepTest™ in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered. For breast cancer patients, results from HER2 IQFISH pharmDx are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

제품 요약:

Models: HER2 IQFISH pharmDx - K5731

승인 날짜:

2019-07-23