Molecular Pathology Laboratory Network, Inc. (MPLN) continues to expand its oncology test menu with an additional application of the CellSearch™ System now available to monitor circulating tumor cells (CTCs) in patients with metastatic prostate cancer. CellSearch is also used to monitor CTCs in metastatic breast and metastatic colon cancers.
CellSearch is an advanced diagnostic platform commercially available from Veridex, LLC that enables the capture, identification and classification of rare CTCs in the blood stream that detach from solid tumors.
The U.S. Food and Drug Administration recently granted expanded clearance for the CellSearch test as an aid in monitoring patients with metastatic prostate cancer. In 2004, CellSearch was approved for detecting and counting CTCs in metastatic breast cancer and in 2007 the FDA approved the test for metastatic colon cancer.
“Information about the number of CTCs can provide early warning signs about the progression of cancer and help physicians determine the best treatment options for their patients,” said Dr. Roger Hubbard founder, president and chief executive officer of MPLN, which is one of the first regional reference laboratories in the Southeast to offer CellSearch.
A prospective, multi-center clinical trial was conducted to validate the expanded clearance for CellSearch. Data showed that patients with less than five CTCs at baseline had significantly better survival rates versus patients with more than five CTCs. Data also showed that CTCs are a strong independent predictor of progression-free survival and overall survival, and that the combination of CTC measurement and prostate specific antigen (PSA) testing provides the most accurate assessment of disease status.
According to the American Cancer Society, one in six men will develop prostate cancer during his lifetime. While only one in 34 will die of the disease, prostate cancer is second only to lung cancer as the leading cause of cancer-related deaths in men in the United States. CellSearch helps physicians predict disease progression and overall patient survival any time during therapy by detecting as low as one CTC in 7.5 ml of whole blood.
“It’s extremely important that the numbers of CTCs stay as low as possible. In situations where CTCs are considered too high, the physician may wish to alter therapy,” Hubbard said.
To help determine if a change in therapy is needed, CellSearch measures CTC levels in the blood sample of patients before a new therapy is initiated and again at routine follow-up visits and in conjunction with imaging. Elevated CTC levels determined by CellSearch from baseline and to subsequent follow-up visits, suggests a patient’s therapy may need to be re-evaluated. Serial testing of CTCs using CellSearch combined with other clinical methods such as CT imaging for monitoring cancer provides the most accurate assessment of disease status.
The CellSearch System is the first diagnostic test to automate the detection and enumeration of CTCs. CellSearch CTC test works by using antibodies conjugated to microscopic iron particles, called ferrofluid particles, which attach very specifically to CTCs. Powerful magnets then “pull” the CTCs out of the blood sample. They are then stained with additional bio-molecules and chemicals so that they can be positively identified as CTCs.
For more information about CellSearch, visit www.MPLNet.com, or contact an MPLN client services specialist at 865-273-1111 or toll free at 866-726-1833.