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

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

  PR Newswire

  RARITAN, New Jersey, December 13, 2012

RARITAN, New Jersey, December 13, 2012 /PRNewswire/ --

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. 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-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. ^[ ^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® 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."

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® CTC Test

CELLSEARCH® 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

^[ ^2 ^] Decision Resources: Breast Cancer in China 2009

Contact: Kellie McLaughlin, +1-908-927-7477, +1-609-468-8356,
Kmclaugh@its.jnj.com; Frederick Wittock, +32(0)14-60-57-24,
fwittock@its.jnj.com
 
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