CellSearch® 'Liquid Biopsy' Approved for Breast Cancer Patients in China

CellSearch® 'Liquid Biopsy' Approved for Breast Cancer Patients in China PR Newswire RARITAN, New Jersey, December 13, 2012 RARITAN, New Jersey, December 13, 2012 /PRNewswire/ -- Veridex, LLC today announced approval from the China State Food & Drug Administration (SFDA) for the CellSearch® circulating tumor cell (CTC) test as an in vitro diagnostic for women with metastatic breast cancer. This makes CellSearch® the first and only approved CTC test for cancer patients in China, which is the seventh country outside of the United States and European Union to clear CellSearch® for use as an aid in the monitoring of patients. The SFDA approval is based on the results of a multi-center, prospective study of 294 women with metastatic breast cancer. The objective of the study was to evaluate whether CTC count, using the CellSearch® test, is predictive of progression-free survival (PFS) and overall survival (OS) in Chinese metastatic breast cancer patients. Results of the study confirmed that women with fewer than 5 CTCs have a more favorable prognosis compared to women with 5 or more CTCs. Median PFS was 42.0 weeks for the group with fewer than 5 CTCs compared to 24.9 weeks for those with 5 or more CTCs. The risk of death in the group with 5 or more CTCs was 4.85 times that of the group with fewer than 5 CTCs. CellSearch® is administered as a routine blood test, a highly sensitive liquid biopsy that can identify as few as one CTC in 7.5 ml of blood.