Colorectal Cancer Monitoring Tool Approved
The CellSearch System, from Veridex LLC, received expanded marketing clearance from the FDA. News of the broadened use of the detection system was publicized on the Johnson & Johnson subsidiary’s website.
The diagnostic tool identifies and counts the number of circulating tumor cells (CTCs) in serum samples procured from patients with colorectal cancer. The automated testing system is the first test that detects and quantifies the presence of CTCs. It is used to evaluate the likelihood that a patient will develop progression of their colon cancer.
The test is intended, in part, by using the test for ongoing monitoring of patients with multiple tests over time. In cooperation with other methods to monitor disease, the test can foster early identification of disease recurrence to ensure rapid treatment as soon after progression is noted. Testing can commence early, patients can be tested following the first treatment cycle.
The Comprehensive Blood and Cancer Center in California will be the first location to begin offering the product with this new indication. The team there notes the benefits of early detection of disease, such as been yielded in the use of the CellSearch System for breast cancer patients
The CellSearch System was originally approved for use in patients with breast cancer to determine if metastases have developed, as described on Hospital Buyer.
November 30, 2007 Related topics: Product Approval & Certification, Diagnostic, Hematology & Oncology