The Spot-Light Her2 CISH kit has received FDA premarket approval in July 2008, as an aid in the assessment of breast cancer patients for whom trastuzumab (Herceptin) treatment is being considered.
The Spot-Light test uses standard histology laboratory methods and equipment to yield valuable gene status information.
Brett Williams, head of anatomical pathology business at Invitrogen, said: “We are pleased to bring this kit to market so quickly after receiving FDA approval. 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.”