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
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.