NeoGenomics FISH Identifies Gastric Cancer Patients for Trastuzumab Therapy

In October 2010, the FDA approved trastuzumab in combination with chemotherapy agents for patients with HER2-overexpressing metastatic gastric or gastroesophageal junction. Similarly, NCCN Guidelines recommend trastuzumab plus chemotherapy for HER2+ metastatic gastric or GE junction cancer. Guidelines are supported by the ToGA trial: Trastuzumab for Gastric Adenocarcinoma (2010). The following were all improved by a statistically significant measure in the group receiving chemotherapy plus trastuzumab compared to those receiving chemotherapy alone: overall survival, progression free survival, time to progression, duration of response, and overall response rate.

Approximately 22% of gastric and GE junction adenocarcinomas (combined) are positive for HER2. Scoring of positive cases differs from HER2 breast cases; NeoGenomics uses the international consensus guidelines validated and used in the ToGA trial.

HER2 overexpression and gene amplification are observed in other tumors including lung, colon, ovarian, and endometrial cancers, which suggests the possibility of therapy for these patients. Our validation study included rigorous testing in tumors from these sites for optimal detection of gene amplification in a range of primary tumors and their metastases.

Product Detail:

Test Name: HER2 Non-breast
Assay description: HER2 Non-Breast FISH test detects HER2 gene amplification in gastric and gastroesophageal junction, lung, colon, ovarian and endometrial tumors and their metastases.
Sensitivity:
Specimen Requirements:

Routine formalin fixation for 6-48 hours is optimal. Zinc fixatives are not acceptable. All tissues are acceptable except decalcified bone.
Paraffin block with one H&E slide (invasive area circled for tech-only), sliced at 4-5 microns
Cut slides: three cut slides with one H&E slide (invasive area circled for tech-only), sliced at 4-5 microns