SPOT-Light HER2 CISH: New Breast Cancer Genetic Test, FDA-Approved

The US FDA has recently approved a new genetic test for breast cancer: the SPOT-Light HER2 CISH kit.

This novel genetic test – a product of Invitrogen Corporation – determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs.

Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

Read more from FDA News.