The China State Food & Drug Administration (SFDA) has granted approval for Veridex's CellSearch circulating tumour 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-centre, 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 favourable 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, 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, 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."
Circulating tumour cells are cancer cells that have detached from the tumour and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs is evolving as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.
CellSearch is the first and only US Food and Drug Administration-cleared in vitro diagnostic (IVD) test to capture and count CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer. The test can be administered at any time during the course of therapy as a routine blood test. It is used in combination with other tests and a clinician's assessment, to provide a more complete picture of a patient's prognosis.
Veridex, LLC, a Johnson & Johnson company, is an organization dedicated to providing physicians with high-value diagnostic oncology products. Veridex's IVD products may significantly benefit patients by helping physicians make more informed decisions that enable better patient care.