HOUSTON--(BUSINESS WIRE)--Sept. 23, 1997--Gamma Biologicals Inc. (AMEX: GBL) announced today that the Food and Drug Administration has approved the company's 510K application to market the Gamma-ReACT(TM) Test System. ReACT is a microcolumn gel technology designed for the rapid and labor-saving detection of red blood cell antibodies.
Gamma submitted the 510K application in October 1996. The company has shipped demonstration units to its domestic sales representatives and to certain international distributors
"Gamma is now able to market ReACT systems world-wide to customers who have been requesting the gel technology. Until now, all we could do in the United States was demonstrate the product," said David E. Hatcher, chairman, president and chief executive officer. "Internationally, we have been limited to sales to our subsidiary in the Netherlands. Our preliminary marketing information indicates that the ReACT system could contribute over $3,000,000 of revenues during the first full year of sales."
Last week, the U.S. Patent Office issued the first of three patents that Gamma applied for regarding ReACT adherence technology. Studies also show that Gamma's unique red cell product line developed specifically for ReACT functions well in other gel column systems.
ReACT's advantages over conventional tube test procedures include prefilled strips, no washing (which manual tests require), ease of use, stable and reproducible results, fast and short centrifuge time (less than three minutes per test compared with up to 10 minutes for available methods), and clear differentiation between positive and negative results.
The ReACT system consists of a centrifuge, an incubator and a disposable strip containing an immunoreactive agarose. The strip is a microcolumn panel of six or eight different tests. Products based on ReACT (Red cell Adherence Column Technology) employ a microcolumn format that minimizes human error and allows subsequent viewing of test results by others. Microcolumn testing has been successfully marketed in Europe since 1988.
Gamma Biologicals manufactures and sells a wide variety of highly refined and specialized testing products known as in-vitro diagnostic reagents. The Company markets to blood donation centers (commonly called "blood banks"), transfusion departments of hospitals, medical laboratories and research institutions through a direct sales force and a distributor network to more than 50 countries. The company's common stock trades on the American Stock Exchange using the symbol GBL. Information about the company is available at www.gammabio.com .
CONTACT:
Gamma Biologicals, Houston
David E. Hatcher, 713/681-8481
or
Jimmie L. Turner, 713/681-8481
KEYWORD: TEXAS
BW0070 SEP 23,1997
|
