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. his 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. Oncologists can use this information, in combination with other diagnostic tests and clinical methods for monitoring metastatic breast cancer, to assess a patient's overall prognosis and help predict progression free survival and overall survival.
An estimated 189,500 women in China are expected to be diagnosed with breast cancer by 2013. Nearly two-thirds of Chinese women with breast cancer are diagnosed in the later stages of the disease Further, the incidence of breast cancer is rising sharply at a rate of 4 percent per year.
"CellSearch® is a useful new tool to help improve the care provided to China's growing number of women affected by metastatic breast cancer," said Minetta C. Liu, M.D., of the clinical molecular diagnostics laboratory at Georgetown University's Lombardi Comprehensive Cancer Center and a key investigator in the CTC study. "The use of CellSearch® in conjunction with other diagnostic tests, such as imaging and routine blood work, provides oncologists with a more accurate and comprehensive understanding of their patients' prognoses."
"We are thrilled to make CellSearch® available for women in China with metastatic breast cancer," said Robert McCormack, Ph.D., Head of Technology Innovation at Veridex. "Oncologists tell us that knowing a patient's CTC count provides them with a second measurement, complementary to traditional imaging, to help them assess the prognosis of a patient."
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