ANOTHER FIRST FOR GAMMA BIOLOGICALS; COMPANY RECEIVES FIRST EVER LICENSE FOR MONOCLONAL COOMBS REAGENTS
ANOTHER FIRST FOR GAMMA BIOLOGICALS; COMPANY RECEIVES
FIRST EVER LICENSE FOR MONOCLONAL COOMBS REAGENTS
HOUSTON, March 2 /PRNewswire/ -- Gamma Biologicals, Inc. (AMEX: GBL), has received the first license ever issued by the Food and Drug Administration for four antihuman globulin (Coombs) reagents manufactured totally from monoclonal antibodies. The Coombs test is one of the most widely performed procedures in clinical medicine, and these reagent products are used routinely in the testing of all blood donors and obstetrical and presurgery patients.
Chairman and President David E. Hatcher said, "This new line of superior products will have a positive effect on the company's revenues and earnings during the coming quarters."
Antihuman globulin reagents are the company's largest dollar sales product line. Gamma obtained the first U.S. license for a monoclonal blood grouping reagent and is the company with the most (14) such products.
Gamma completed field testing on the monoclonal Coombs reagents and filed with the FDA in November 1990. Because of FDA budget limitations, the review process took longer than the normal six months.
Gamma owns the clones for the total Coombs line and cultures the raw materials in-house, which guarantees supply and substantially reduces cost.
Since 1945, the Coombs reagent source has been immunized rabbit blood serum. The newly approved monoclonal reagents will allow the company to retire its rabbit colony within two years.
Gamma Biologicals manufactures and markets a wide range of highly refined and specialized testing products, known as diagnostic reagents, as well as specialized instrument systems. The company markets to hospitals, blood banks, medical laboratories, physicians' offices and research institutions.
/CONTACT: David E. Hatcher, chairman and president, or John J. Moulds, executive vice president of Gamma Biologicals, 713-681-8481/
(GBL) CO: Gamma Biologicals Inc. ST: Texas IN: MTC SU : SM -- NY030 -- 3856 03/02/92 10:30 EST