Invitrogen Corp, Carlsbad, Calif, a provider of essential life science technologies for research, production and diagnostics, has signed an exclusive US distribution agreement with Biocare Medical LLC, for the new SPOT-Light® HER2 CISH Kit. The kit received US 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 CEO.  “We are enthusiastic about being selected as the exclusive US 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, and one user per laboratory must successfully complete Invitrogen’s HER2 CISH certification program. Full certification details are available on Invitrogen’s Web site.