Centocor Inc. has ceased U.S. sales of five experimentalmonoclonal antibody assays it had been selling forinvestigational use only, the company said Wednesday.
The products are CA 19-9 to detect pancreatic cancer, CA 15-5to detect breast cancer, CA 72-4 to detect gastric cancer, C219 to evaluate drug resistance, and a gamma interferon assay.
Centocor of Malvern, Pa., is conducting clinical trials of CA19-9 and CA 15-5 and said it hopes to submit CA 19-9 formarketing approval next year. The company has no currentplans to run clinical trials on the other products.
Centocor stopped sales because the Food and DrugAdministration asked the company to supply the assays underan investigational device exemption. The company previouslysupplied them under an investigational use only label, saidcompany spokesman Charles Cabot III.
The changes in the FDA's requirements "are extensive enough tomake it no longer profitable for us," said Cabot. Centocor(NASDAQ:CNTO) had total 1990 domestic sales of $2.9 millionfor these products. Cabot said the loss of sales, which wereless than 5 percent of total revenues, wouldn't affect earnings.
The products will continue to be sold in Europe, Canada andJapan, where they have received marketing approval.
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