RARITAN, N.J., Dec. 27, 2012 -- Veridex, LLC today announced that new Category I Current Procedural Technology (CPT) codes for circulating tumor cell (CTC) testing will go into effect in the United States on January 1, 2013. CPT codes are assigned by the American Medical Association (AMA) to medical, surgical, and diagnostic services to communicate uniform information about medical services and procedures among physicians, patients, payers and others for administrative, financial, and analytical purposes. The new codes for CTC testing will cover both the administration of the test (code 86152) and the interpretation of results by a qualified healthcare provider (code 86153).
The Centers for Medicare and Medicaid Services (CMS) established a national payment rate for the interpretation code; however, each Medicare contractor will establish its own payment rate for the test code based on gap fill methodology. The new rates will also become effective January 1, 2013.
Today's announcement is a demonstration of the increasing evidence of the clinical utility of CTC testing, in conjunction with other testing methods, as a predictor of overall and progression-free survival. Category I codes are assigned to services and procedures whose clinical efficacy has been well established and documented in U.S. peer-reviewed literature.
The Veridex CELLSEARCH® test, indicated for use in metastatic breast, colorectal, and prostate cancer patients, is the only CTC test that has been cleared through the FDA 510(k) review process. "We are pleased that these new codes and reimbursement rates are being implemented nationally," said Vicki Vakiener, Global Business Leader, Oncology Diagnostics, Veridex, LLC. "We are confident this will enable more physicians to better manage their patients with metastatic breast, colorectal, and prostate cancer. The data provided by CELLSEARCH® is vital for patients too, as it enables them to play an active role in making choices regarding their care."
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 an in vitro diagnostic (IVD) test that captures and counts CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer. It is the only IVD test for CTCs to be cleared by the U.S. Food & Drug Administration, approved by the China State Food & Drug Administration, meets the requirements of the European Commission, and is registered with the Health Authorities in Latin America. CELLSEARCH® can be administered at any time during the course of therapy as a routine blood test and is used, in combination with other tests and a clinician's assessment, to provide a more complete picture of a patient's prognosis.
For in vitro diagnostic use.
The CELLSEARCH® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.
The presence of CTC in the peripheral blood, as detected by the CELLSEARCH® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal or prostate* cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast, colorectal or prostate cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
*Metastatic prostate cancer patients in this study were defined as having two consecutive increases in the serum marker PSA above a reference level, despite standard hormonal management. These patients are commonly described as having androgen-independent, hormone-resistant, or castration-resistant prostate cancer.
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 www.veridex.com.