NEW YORK (GenomeWeb News) – Chinese regulators approved Veridex's CellSearch circulating tumor test for aiding in the diagnosis of women with metastatic breast cancer, Veridex announced on Wednesday.
The Johnson & Johnson firm said the test is the first and only approved CTC test for cancer patients in China, and the approval from the China State Food and Drug Administration makes China the seventh country outside of the US and the European Union to clear CellSearch as an aid in the monitoring of patients.
Veridex offers tests on the CellSearch platform for prostate and colorectal cancers, and melanoma, in addition to metastatic breast cancer.
Veridex said the test can identify as few as one CTC in 7.5 milliliters of blood, and in combination with other diagnostic tests and clinical methods, CellSearch can be used by doctors to assess a patient's overall prognosis and predict progression-free survival, as well as overall survival.
An estimated 189,500 women in China are expected to be diagnosed with breast cancer in 2013.