FDA Panel recommends Biomira's TRUQUANT(R) BR(TM) blood test for detection of recurrent breast cancer.EDMONTON, Alberta--(BUSINESS WIRE)--Sept. 21, 1995--Biomira Inc. (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). , ME: BRA, 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 : BIOMF) today announced that the U.S. Food and Drug Administration's (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. ) Immunology Devices Advisory Panel had recommended the approval of TRUQUANT(R) BR(TM) RIA blood test for the detection of recurrent breast cancer. The Premarket Approval Application (PMA) was submitted by Biomira Diagnostics Inc., a wholly-owned subsidiary located in Toronto. The Advisory Panel had recommended approval of the PMA, subject to certain conditions being met by the company. The clinical trials were conducted at five hospitals in the U.S.: The Bowman Gray School of Medicine, University of California, Los Angeles UCLA comprises the College of Letters and Science (the primary undergraduate college), seven professional schools, and five professional Health Science schools. Since 2001, UCLA has enrolled over 33,000 total students, and that number is steadily rising. , University of Minnesota (body, education) University of Minnesota - The home of Gopher. http://umn.edu/. Address: Minneapolis, Minnesota, USA. , the Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. and the University of Texas M.D. Anderson Cancer Center. "The unanimous recommendations of the Panel to the FDA that this product be approved was supported by data which demonstrated that the TRUQUANT(R) BR(TM) blood test is safe and effective in the diagnosis of recurrent breast cancer. This blood test could lead to improved diagnosis in the disease management of over one million breast cancer survivors in the United States who are at risk of recurrent disease. "We are pleased with this positive recommendation of the FDA Panel and now await the final decision of the FDA on the approval for this product on the United States," said Alex McPherson, M.D., Ph.D., Biomira's president and CEO. Biomira is a biotechnology company developing an integrated line of products for cancer management. CONTACT: Biomira Inc. Jane Jack, 403/490-2812 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion