AsianScientist (Dec. 24, 2012) – A new circulating tumor cell test developed by New Jersey-based Veridex, LLC for metastatic breast cancer has been approved by the China State Food & Drug Administration (SFDA).
Circulating tumor cells (CTCs) are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs in personalized cancer therapy is evolving as more research data is gathered on its utility.
CellSearch®, the first and only approved CTC test for cancer patients in China, is also approved by the U.S. Food and Drug Administration as a diagnostic test to determine the prognosis of patients with metastatic breast, colorectal, or prostate cancer.
The SFDA approval is based on the results of a multi-center, prospective study of 294 women with metastatic breast cancer, which evaluated whether CTC count using the CellSearch® test is predictive of progression-free survival (PFS) and overall survival (OS) in Chinese metastatic breast cancer patients.
The Veridex study showed that women with fewer than five CTCs have a more favorable prognosis compared to women with five or more CTCs.
Median PFS was 42.0 weeks for the group with fewer than five CTCs compared to 24.9 weeks for those with five or more CTCs, while the risk of death in the group with five or more CTCs was 4.85 times that of the group with fewer than five CTCs.
Administered as a routine blood test, Veridex says the test 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 a clinician’s assessment, to provide a more complete picture of a patient’s prognosis.
“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 Dr. Minetta C. Liu, 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.”
An estimated 189,500 women in China are expected to be diagnosed with breast cancer by 2013, and the incidence of breast cancer is rising sharply. Nearly two-thirds of Chinese women with breast cancer are diagnosed in the later stages of the disease.
——
Source: Johnson & Johnson; wellcome images/Flickr/CC.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.
