Veridex, LLC, a Johnson & Johnson company, has announced that new Category I Current Procedural Technology (CPT) codes for circulating tumour 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 US 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."

Circulating tumour cells are cancer cells that have detached from the tumour 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.

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 US 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.

Veridex, LLC, a Johnson & Johnson company, is an organization dedicated to providing physicians with high-value diagnostic oncology products.