Veridex, LLC, a Johnson & Johnson company, has announced an agreement with LabCorp Clinical Trials that makes the CELLSEARCH circulating tumor cell, or CTC, test available for researchers conducting clinical trials in China.
CELLSEARCH is the FDA 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.
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 tool in developing new therapeutic options.
"The value of CTCs as an oncology biomarker is well documented in peer-reviewed literature," commented Robert McCormack, 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."