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

Raritan, New Jersey (ots/PRNewswire) -

Veridex, LLC today announced approval from the China State Food &
Drug Administration (SFDA) for the CellSearch(R) circulating tumor
cell (CTC) test as an in vitro diagnostic for women with metastatic
breast cancer. This makes CellSearch(R) 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(R) 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(R) 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(R) 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.[2] Nearly two-thirds of Chinese women
with breast cancer are diagnosed in the later stages of the
disease[1]. Further, the incidence of breast cancer is rising sharply
at a rate of 4 percent per year.[2]

"CellSearch(R) 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(R) 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(R) 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."

About Circulating Tumor Cells

Circulating tumor cells 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 is evolving as more research
data is gathered about the utility of these markers in monitoring
disease progression and potentially guiding personalized cancer
therapy.

About CELLSEARCH(R) CTC Test

CELLSEARCH(R) is the first and only U.S. 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.

About Veridex, LLC

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. Veridex's Clinical Research Solutions provide tools and
services that may be used for the selection, identification and
enumeration of targeted rare cells in peripheral blood for the
identification of biomarkers, aiding scientists in their search for
new, targeted therapies. For more information, visit
http://www.veridex.com.

[1]CancerMPact China 2010, Kantar Health and Draco Healthcare
Consulting LLC
[http://www.chinadaily.com.cn/china/2012-03/12/content_14814002.htm ]

[2]Decision Resources: Breast Cancer in China 2009
[http://www.chinadaily.com.cn/china/2010-10/25/content_11455432.htm ]

ots Originaltext: Johnson & Johnson and Janssen
Im Internet recherchierbar: http://www.presseportal.de

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