First Serum Tumor Marker for Detecting Recurrent Breast Cancer

May 1, 1996

TORONTO--TRUQUANT BR RIA, Biomira Diagnostics Inc.'s radio-immunassay, has been cleared for marketing for the early detection of recurrent breast cancer in patients previously treated for stage II or III cancer. According to the company, it is the first breast tumor marker test to receive expedited review by the FDA and is the first such test to be approved. The test is expected to cost approximately $50, the company said.

TORONTO--TRUQUANT BR RIA, Biomira Diagnostics Inc.'s radio-immunassay,has been cleared for marketing for the early detection of recurrentbreast cancer in patients previously treated for stage II or IIIcancer. According to the company, it is the first breast tumormarker test to receive expedited review by the FDA and is thefirst such test to be approved. The test is expected to cost approximately$50, the company said.

TRUQUANT BR RIA detects the presence of CA27.29 antigen, a mucinousglycoprotein product of the MUC-1 gene that is present on breastcancer cells and is shed into the bloodstream in high levels asbreast cancer metastasizes. Routine monitoring for CA27.29 antigenwith the new assay is indicated for use in conjunction with otherclinical methods for the early detection of breast cancer recurrence.

The test was evaluated in a 3-year prospective double-blind multicenterclinical trial of 166 breast cancer patients with stage II orIII breast cancer who were clinically free of disease at the timeof enrollment.

Researchers found that positive results with TRUQUANT BR RIA couldpredict with high probability the recurrence of disease, providingup to 12 months lead time (average, 5 months) over clinical symptomsand/or general or specific imaging techniques.