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Breast Cancer
Blood Test Receives Clearance to Monitor Cancer Treatment
November 24th, 1997
Biomira Inc., Edmonton, Alberta, Canada, announced clearance by the U.S. Food and Drug Administration (FDA) for the company's blood test kit, Truquant BR RIA (Radioimmunoassay) as an aid in monitoring response to therapy in patients with Stage IV breast cancer. The kit received 510(k) clearance for a monitoring claim, adding to the 1996 U.S. marketing clearance of Truquant BR blood test kit as an aid in the detection of recurrent breast cancer. Biomira launched its Truquant BR RIA blood test kit for the detection of recurrent breast cancer in the U.S. in 1996, after a three-year clinical trial in patients previously treated for Stage II or Stage III...
Source: Cancer Weekly (1997-11-24)
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