Breast Cancer Test Introduced
The Food and Drug Administration issued marketing clearance to Invitrogen Corporation for the company’s new genetic breast cancer test. The SPOT-Light HER2 CISH kit is indicated to determine the number of HER2 gene copies in malignant tissue.
Testing requires procurement of a small tumor specimen. The sample is stained and the number of HER2 gene copies are determined. Staining changes the color of the HER2 genes, which allows specimen assessment with a standard microscope. The technique used is chromogenic in situ hybridization (CISH), which quantifies HER2 expression.
This eliminates the requirement for expensive and complex fluorescent microscopy tools. Another advantage of this new tool is that laboratories may store specimens, which allows samples to be assessed in the future.
The test is intended to support clinicians in determining the appropriate treatment regimen for a given patient. Patients with an overproduction of HER2 are generally treated with Herceptin, which is intended to reduce HER2 production.
This is the company’s first approval from the FDA. The test will be made available in the U.S. over the next few weeks.
July 17, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Laboratory Equipment, Diagnostic