Hemagen receives FDA clearance to market test for Chagas disease.WALTHAM, Mass.--(BUSINESS WIRE)--May 31, 1995--Hemagen Diagnostics Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : HMGN HMGN Hemagen Diagnostics, Inc. (stock symbol) ) today reported it has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance to market a test to detect Chagas disease, a widespread and often fatal disease in Latin America which is becoming an increasing concern in the United States. Dr. Carl Franzblau, president of Hemagen, said that Chagas, also known as American trypanosomiasis, is an insect-borne parasitic disease which also can be transmitted by standard blood transfusion. Chagas is a progressive and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction disease affecting and estimated 24 million people throughout Latin America. A majority of those with the disease die within 10 to 15 years, generally from heart failure caused by the parasite. Franzblau said blood banking leaders in the United States have expressed a growing concern over the possibility of Chagas transmission through donated blood, particularly because of the rapid increase in immigration immigration, entrance of a person (an alien) into a new country for the purpose of establishing permanent residence. Motives for immigration, like those for migration generally, are often economic, although religious or political factors may be very important. from Latin America. He said, however, that Chagas testing is not yet a part of the donated blood screening routine in the United States, although such testing is required in most South American blood banks. Hemagen recently developed a Chagas test which is being introduced to the South American market by Boehringer Mannheim, one of the largest international producers of clinical diagnostic products. Hemagen also sells Chagas tests under its own label in Brazil, where it is used in blood banks and clinical laboratories. Franzblau said Hemagen's Chagas test cleared by the FDA is in the increasingly popular enzyme immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. (ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent. ELISA n. ) format which the company is using for most of the new assays it is developing. Hemagen Diagnostics Inc. develops, manufactures and markets proprietary medical diagnostic test kits used to aid in the diagnosis of autoimmune and infectious diseases. The company also is developing a line of tests for use in blood banks. Hemagen focuses on niche markets which offer significant growth opportunities. CONTACT: Hemagen Diagnostics, Waltham Peter von Stein, 617/890-3766 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion