Clinical trials of Epigen Inc.'s first product, an in vitro blood test thatdetermines if a breast cancer patient is being treated successfully, willbegin in April, the Wellesley, Mass., company announced Tuesday.The product, called the "COD Test," measures nanogram levels ofHCA, an antigen that appears on the surface of tumors and correlateswith tumor burden. Once the cancer is in remission, the test will revealwhether there have been recurrences.Epigen President Jim Mongiardo told BioWorld that a retrospectivetrial to test banked breast cancer serum samples will be conducted first.That will be expanded into a prospective trial, required by the FDA, inwhich new patients will be tested and followed for about two years. Hesaid the retrospective trial is all that is required by European regulatoryauthorities, and the COD Test should be on the market there in a year.Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.