NEW YORK (GenomeWeb News) – Biocare Medical will distribute Invitrogen’s new SPOT-Light HER2 CISH Kit in the US under an exclusive agreement announced Monday after the close of the market.
The test, which received US Food and Drug Administration clearance in early July, can be used to assess whether breast cancer patients should be treated with Genentech’s Herceptin (trastuzumab). It marked the first premarket approval Invitrogen has received from FDA for a diagnostic product.
Biocare is a supplier of immunohistochemistry reagents, multiplex stains, and automated platforms for the anatomic pathology market.
Laboratories purchasing Invitrogen’s HER2 test kit must complete Invitrogen’s HER2 CISH certification program, as required by the FDA clearance. The firm expects the primary users to be pathologists, oncologists, and histotechnologists who determine the best course of treatment for breast cancer patients.
“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,” Biocare CEO Roy Yih said in a statement.