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HerScan™ for Breast Cancer

Chronic lymphocytic leukemia (CLL)

ATScan™ for Autism

LEARN ABOUT HERSCAN™ FOR BREAST CANCER

The HerScan™ Test is the First Array-based Diagnostic to Comprehensively Analyze HER2 Gene Status and A Patient's Tumor Genome

The HerScan™ test is designed to give pathologists and oncologists an objective measure of HER2 gene copy number with simultaneous analysis of the entire tumor genome. As a function of the enumeration of the HER2 gene through the HerScan test, patients are assigned to one of four categories of HER2 gene status: Amplification, Gain, Normal, or Loss.

The College of American Pathologists (CAP) and American Society of Clinical Oncology (ASCO) have recently recommended that HER2 status be determined in all invasive breast cancers as a prognostic marker for which patients are most likely to benefit from the breast cancer drug trastuzumab (Herceptin(r)). However, it is estimated that approximately 20 per cent of HER2 testing currently being performed by the two available methods, immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH), may be inaccurate. Although new CAP and ASCO guidelines have been issued to address inconsistencies arising from the inherent subjectivity of FISH and IHC techniques, problems with these existing methods remain unresolved. With the HerScan test, HER2 gene copy number is objectively analyzed for the determination of amplification status (amplification, gain, no change, or loss) at the genomic level.

Breast cancer is the most common malignancy in women in the United States, which has over 200,000 new cases diagnosed every year. Approximately 20 per cent of newly diagnosed breast cancer cases have extra copies of the HER2 gene on chromosome 17 (called HER2-positive), and thus these patients have a concomitant poor prognosis due to the aggressive disease characteristics conferred by the extra dosage of the HER2 gene product. HER2-positive tumors are likely to respond to the Herceptin drug because it is designed to target the product of the HER2 oncogene. Conversely, it is important to accurately identify patients with normal copy number or loss of the HER2 gene (HER2-negative) because, for these patients, the risks of side effects, including cardiotoxicity, are greater than any potential benefit of the drug.

As part of the validation of the HerScan™ test, clinical testing was completed on over 100 cases of invasive ductal and invasive lobular carcinoma with known IHC and/or FISH results. The HerScan™ test accurately and reproducibly determined HER2 status, and in addition it clearly revealed the genomic subtypes previously reported in Cancer Research 64: 8541-8549; 2004. These subtypes include tumors showing gain of chromosome 1q; loss of chromosome 16q; amplification of the c-MYC oncogene on chromosome 8; and loss of the tumor suppressor gene P53 on chromosome 17. These additional markers, which are not simultaneously available by IHC or FISH, provide additional relevant information, enabling the clinician to make better patient management decisions and recommendations

Talk with your physician about ordering the HerScan™ test today.

Recent scientific publications demonstrate the importance of detecting genome-wide abnormalities in breast cancer when evaluating whether a patient has high, intermediate or low risk disease. Below are some recent studies and news reports on breast cancer.

Articles of Interest About the HER2 Gene and Breast Cancer

Cancer Research 64: 8541-8549; 2004

Journal of National Cancer Institute 99:1064-1065; 2007

Links of Interest

http://www.herceptin.com/herceptin/patient/index.jsp?s_cid=0001&s_src=googleppc&segmentID=1530

http://www.aacr.org/home/public--media/for-the-media/fact-sheets/cancer-concepts/her2.aspx