Healthcare Industry News:  cell therapy 

Diagnostics FDA

 News Release - September 15, 2008

Invitrogen, Biocare to Market FDA Approved Breast Cancer Test

HER2 CISH Gene Amplification Test Now Available

CARLSBAD, Calif.--(HSMN NewsFeed)--Invitrogen Corporation, (NASDAQ:IVGN ), a provider of essential life science technologies for research, production and diagnostics, has signed an exclusive U.S. distribution agreement with Biocare Medical LLC, a leading provider of immunohistochemistry reagents, multiplex stains, and automated platforms for the anatomic pathology market, for the new SPOT-Light® HER2 CISH Kit. The kit received U.S. Food and Drug Administration premarket approval in July, as an aid in the assessment of breast cancer patients for whom trastuzumab (Herceptin®) treatment is being considered.

Approximately one million people worldwide are screened each year for HER2 amplification or over-expression. The importance of genetic tests like HER2 CISH is growing because some targeted cancer therapies (like trastuzumab) are most effective in patients who overexpress the HER2 gene. The primary users will be pathologists, oncologists, and histotechnologists who will determine the best course of treatment for breast cancer patients. The SPOT-Light® test uses standard histology laboratory methods and equipment to yield valuable gene status information.

“We are pleased to bring this kit to market so quickly after receiving FDA approval,” said Brett Williams, head of Invitrogen’s Anatomical Pathology Business. “Working with the Biocare sales force, we believe we will be able to more rapidly and efficiently deliver this critical diagnostic product to clinicians who are making life-saving decisions for their breast cancer patients.

“Biocare’s rapid growth has been fueled by providing award winning technical and customer service in addition to novel products for anatomic pathology and research laboratories,” said Roy Yih, Biocare Chief Executive Officer. “We are enthusiastic about being selected as the exclusive U.S. distribution channel for the SPOT-Light HER2 CISH Kit. This product is the first FDA approved product to provide the confidence and objectivity of in-situ hybridization with the ease of immunohistochemistry, enabling a wider number of anatomic pathology laboratories to perform this critical test.”

Per FDA requirements, laboratories must be certified prior to purchasing the SPOT-Light® HER2 CISH Kit for use on patient specimens. One user per laboratory must successfully complete Invitrogen’s HER2 CISH certification program. Full certification details are available at After certification, the SPOT-Light® HER2 CISH Kit may be ordered by calling (800) 799-9499 or at

About Invitrogen

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

About Biocare Medical

Biocare Medical LLC is an innovator in developing and supplying world class automated immunohistochemistry instrumentation, and the full range of reagents for IHC lab testing. Biocare is the market leader in simultaneous multiplex stain IHC and antibody cocktail development which solves difficult clinical problems and accelerates turnaround time

The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets using tissue immunostaining. Biocare medical is headquartered and has manufacturing facilities in Concord, Calif., and has a global distribution network.

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; a) Invitrogen and Biocare will be able to offer the product rapidly and efficiently to clinicians. Potential risks and uncertainties include, but are not limited to; 1) the SPOT-Light HER2 CISH Kit may or may not be the first FDA approved product to provide the confidence and objectivity of in-situ hybridization with the ease of immunohistochemistry; 2) the SPOT-Light HER2 CISH Kit may or may not enable a wider number of anatomic pathology laboratories to perform this critical test; as well as 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® is a registered trademark of Genentech. No sponsorship or endorsement by Genentech is implied herein.

Source: Invitrogen

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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