FDA Grants Invitrogen Premarket Approval of Breast Cancer Test
HER2 Gene Amplification Test Will Aid in Assessing Breast Cancer Patient Candidacy for Herceptin(R) Treatment
CARLSBAD, Calif., Jul 08, 2008 (BUSINESS WIRE) -- Invitrogen Corporation, (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its SPOT-Light(R) HER2 CISH Kit, indicated as an aid in the assessment of breast cancer patients for whom trastuzumab (Herceptin(R)) treatment is being considered. The approval marks the first PMA that Invitrogen has received from the FDA.
"The introduction of the SPOT-Light(R) 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 percent 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 overexpression. 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(R) 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."
The SPOT-Light(R) HER2 CISH Kit will be available in the U.S. in mid-August.
Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.
Safe Harbor Statement
Certain statements contained in this press release are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, and it is Invitrogen's intent that such statements be protected by the safe harbor created thereby. Forward-looking statements include, but are not limited to 1) Because the SPOT-Light(R) HER2 CISH Kit doesn't need specialized equipment; any histology lab can now assess amplification of the HER2 gene while simultaneously examining tissue morphology. Potential risks and uncertainties include, but are not limited to the risks that the market will not accept the companies' products and services, or that the companies will be unsuccessful in their efforts to develop new products and services, as well as other risks and uncertainties detailed from time to time in Invitrogen's Securities and Exchange Commission filings.
Herceptin(R) is a registered trademark of Genentech. No sponsorship or endorsement by Genentech is implied herein.