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.
TRUQUANT BR RIA detects the presence of CA27.29 antigen, a mucinous glycoprotein product of the MUC-1 gene that is present on breast cancer cells and is shed into the bloodstream in high levels as breast cancer metastasizes. Routine monitoring for CA27.29 antigen with the new assay is indicated for use in conjunction with other clinical methods for the early detection of breast cancer recurrence.
The test was evaluated in a 3-year prospective double-blind multicenter clinical trial of 166 breast cancer patients with stage II or III breast cancer who were clinically free of disease at the time of enrollment.
Researchers found that positive results with TRUQUANT BR RIA could predict with high probability the recurrence of disease, providing up to 12 months lead time (average, 5 months) over clinical symptoms and/or general or specific imaging techniques.