Johnson and Johnson receives FDA clearance for CellSearch

Veridex, a Johnson & Johnson company, has announced that the US Food and Drug Administration (FDA) has given expanded clearance for its CellSearch system to be used in monitoring metastatic colorectal cancer.

CellSearch is already approved for monitoring metastatic breast cancer and works by identifying and counting circulating tumour cells (CTCs) in a blood sample to predict progression-free survival and overall survival.

CellSearch results can be used in conjunction with other clinical methods to help physicians assess disease progression and make informed care decisions earlier.
Robert McCormack, vice-president of medical and scientific affairs at Veridex, confirmed the importance of identifying CTCs in the fight against metastatic cancers.

“Elevated CTCs in the blood stream are associated with lower survival rates. We believe, based on the clinical research, that identifying CTCs as soon as possible can lead to improved patient outcomes.”

The CellSearch system was originally cleared by the FDA in January 2004 for use in the treatment of metastatic breast cancer.

Subsequent studies demonstrating the efficacy of CellSearch in metastatic colorectal patients provided the basis for this week’s FDA decision.

Veridex is focused on the provision of medical products for in-vitro diagnostic oncology that benefit patients through earlier detection of disease.