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First Test to Monitor Pancreatic Cancer Receives FDA Clearance

First Test to Monitor Pancreatic Cancer Receives FDA Clearance

Fujirebio Diagnostics recently announced that its CA 19-9 radioimmunoassay for monitoring of pancreatic cancer patients received marketing clearance from the US Food and Drug Administration (FDA). The CA 19-9 radioimmunoassay is the first blood test cleared for use in pancreatic cancer.

"This is great news," said Herbert A. Fritsche, PhD, professor, biochemist, and chief of clinical chemistry at M. D. Anderson Cancer Center in Houston. "Recent reports, mainly from Europe, have shown that serial measurements of serum CA 19-9 can reflect the response of patients to chemotherapy. The availability of the CA 19-9 test in the United States will give us a new tool for early assessment of the effectiveness of the many new drugs that are becoming available for the treatment of metastatic cancer of the pancreas."

CA 19-9 is already available in many countries around the world and is used by oncologists to measure the effectiveness of pancreatic cancer treatment. A decrease in CA 19-9 values correlates with a positive response to therapy; an increase may indicate progressive disease and the need for reassessment of the treatment regimen. Pancreatic cancer is the fourth leading cause of cancer death in the United States.

Enables Clinical Decisions

"The CA 19-9 assay has now been clinically proven in studies performed in the United States to correlate with disease status," said Daniel J. O’Shannessy, PhD, chief scientific officer, Fujirebio Diagnostics. "Since it is a simple blood test, the CA 19-9 assay should aid significantly in the management of this devastating disease by providing information to aid in the assessment of disease status and modify therapies appropriately."

According to the American Cancer Society, an estimated 29,200 new cases of pancreatic cancer were diagnosed in the United States in 2001, with 28,900 deaths reported. The overall 1-year survival rate is approximately 19% and the 5-year survival rate is approximately 3%. Clinical management of the disease is very difficult because most cases have spread beyond the pancreas at the time of diagnosis.

"CA 19-9 is an extremely useful marker of disease status, especially when assessed frequently since, in conjunction with clinical assessment, it enables clinical decisions with respect to treatment options to be made earlier to the benefit of the patient," said Jules Harris, MD, The Judd and Majorie Weinberg Presidential Professor of Medicine, professor of Immunology and Microbiology, Rush Medical College in Chicago. "The availability of CA 19-9 in the United States will positively impact the care and management of patients with pancreatic cancer."

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