Epigen Inc. Tuesday reported that clinical trials of its COD Test tomonitor breast cancer patients yielded significant results in trackingrecurrence of the disease.James Mongiardo, president of the Wellesley, Mass.-based company,said he expects to begin an expanded study of the breast cancer bloodtest in the fall and, depending on the results, file a premarket approvalapplication (PMA) with the FDA next year.The trial just completed involved 54 patients at two sites, ColumbianPresbyterian and Milton S. Hershey medical centers. The COD Testwas used to analyze 273 blood samples taken and frozen at variousintervals following the patients' cancer treatments. The results of theCOD Test were compared, retrospectively, with the findings ofphysicians who monitored the patients for cancer progression.In the study at Hershey Medical Center in Hershey, Pa., all 20 patientsexperienced recurrence. Mongiardo told BioWorld the COD Test of131 blood samples successfully detected the disease's progression in62.5 percent of them. And Mongiardo said that "in most cases"Epigen's test recognized the cancer "one to eight months" before thephysicians did.The trial at Columbian Presbyterian in New York involved 34 patientsand 142 blood samples. The performance of the COD Test wascompared not only with the physicians' findings, but with results fromtwo other experimental blood tests, CEA and CA15.3.Mongiardo said the COD Test results matched the analysis of thephysicians in 100 percent of the patients whose cancer stabilized and50 percent of the patients who experienced recurrences. In bothinstances, he said, the COD Test was more accurate than the CEA andCA15.3 tests.In prospective trials expected to begin this fall, COD Tests will beconducted on blood samples as they are taken from patients to trackcancer progression following treatments.The COD Test measures nanogram levels of human carcinoma antigen(HCA) in the blood. Epigen said that because HCA is a tumor-associated antigen, "there is a direct correlation between the size of thetumor and the quantity of HCA in the blood."The company said the U.S. has no FDA-approved blood tests formonitoring breast cancer. n

-- Charles Craig

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