Raritan, NJ – January 17, 2013 – Veridex, LLC today announced an agreement with LabCorp Clinical Trials that makes the CELLSEARCH®circulating tumor cell (CTC) test available for researchers conducting clinical trials in China. This marks the first clinical reference laboratory in China that offers CTC testing and comes on the heels of China’s State Food & Drug Administration approval of CELLSEARCH® as an in vitro diagnostic to manage patients with metastatic breast cancer.
Under this agreement, LabCorp’s Beijing central laboratory will offer CTC testing on the CELLSEARCH® platform to customers conducting clinical trials in China. Drug developers use CTCs in their development programs to perform “liquid biopsies” and assess the number and nature of CTCs in study participants’ blood streams. An increase or decrease in the number of CTCs can be an early and strong indicator of a drug’s efficacy. The highly sensitive CELLSEARCH® test can identify as few as one CTC in a tube of blood, offering researchers a powerful tool in developing new therapeutic options.
“The value of CTCs as an oncology biomarker is well documented in peer-reviewed literature,” commented Robert McCormack, Ph.D. and Head of Technology Innovation at Veridex. “As the number of clinical trials in China continues to rise, drug companies conducting trials there now have another compelling reason to incorporate CTCs into their protocols. Local testing will provide faster results for clinical trial investigators.”
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 potential clinical benefit of capturing and counting CTCs is being investigated as more research data is gathered about the potential utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.
About the CELLSEARCH ® CTC Test
CELLSEARCH® is the first and only United States Food & Drug Administration 510(k)-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 IVD products may significantly benefit patients by helping physicians make more informed decisions that enable better patient care. Veridex 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 www.veridex.com.
Media Contact:
Kellie McLaughlin
Communications Lead
Oncology Therapeutic Area and the Global Medical Organization
Janssen Global Services, LLC
Office: 908-927-7477
Email: kmclaugh@its.jnj.com