Invitrogen Corporation, a provider of essential life science technologies for research, production and diagnostics, has received US Food and Drug Administration (FDA) pre-market approval (PMA) for its SPOT-Light HER2 CISH Kit, indicated as an aid in the assessment of breast cancer patients for whom trastuzumab (Herceptin) treatment is being considered. The approval marks the first PMA that Invitrogen has received from the FDA.

"The introduction of the SPOT-Light HER2 CISH Kit is another example of how Invitrogen technologies can be used in a clinical setting to have a direct impact on healthcare," said Greg Lucier, chairman and chief executive officer of Invitrogen. "The FDA's approval of this kit for the U.S. market also demonstrates our ability to apply Invitrogen technologies into high-growth applied markets."

The kit is based on a technology called chromogenic in situ hybridization (CISH). The test uses a DNA probe for the HER2 gene, which is amplified in 18 to 30 per cent of breast cancers and predicts whether a breast cancer patient is a candidate for trastuzumab treatment. Current medical practice requires that all patients who are considered for trastuzumab treatment be tested for HER2 amplification or over-expression. CISH test results are visualized under a standard bright-field microscope, as opposed to fluorescent in situ hybridization tests, in which the results must be visualized using a fluorescent microscope. This specialized microscope frequently requires that the analysis is done at a reference lab. In addition, HER2 CISH test results are quantifiable; removing the subjectivity inherent in tests based on immunohistochemistry (IHC) interpretation schemes.

"The current protocol for assessing HER2 gene status is for labs to initially screen tissue samples with immunohistochemistry to gauge whether there is an overabundance of the HER2 protein, as an indirect measure of gene amplification," said August Sick, vice president and general manager of Invitrogen's Cellular Analysis Business. "In the case of an inconclusive test, the samples are typically sent to an outside lab for confirmation. Because the SPOT-Light HER2 CISH Kit doesn't need specialized equipment, any histology lab can now assess amplification of the HER2 gene while simultaneously examining tissue morphology."

"Given the emerging potential use of trastuzumab in the adjuvant setting, the need to accurately determine the front-line HER2 status in breast cancer has never been more critical," said Jeffrey Ross, M.D., Cyrus Strong Merrill Professor and Chair, Department of Pathology and Laboratory Medicine, Albany Medical College. "The CISH method has shown a high concordance with fluorescent in situ hybridization (FISH)-based assays for the identification of HER2 gene amplification, now considered the standard for confirming eligibility to receive the drug. Testing for HER2 status in breast cancer by CISH takes advantage of the best attributes of FISH using familiar, fast and low cost IHC detection techniques. This is a true marriage between the two procedures."