MALVERN, Penn--Centocor Diagnostics has introduced Centocor CA 125 II, a second-generation radioimmunoassay for the management of ovarian cancer. The new assay, a more sensitive version of Centocor CA 125, uses the same tracer antibody, OC125, but a new capture antibody, M11, to measure serum CA 125 levels.
According to the company, the new capture antibody enhances resolution, which translates into superior analytical precision, especially at low CA 125 concentrations.
The assay is used to detect residual epithelial ovarian cancer after primary therapy; to determine tumor recurrence, progression, or regression; and to evaluate postmenopausal women with suspected ovarian masses when used in conjunction with other tests.
A large-scale National Cancer Institute trial is underway to determine if routine screening of asymptomatic individuals with CA 125 II and other screening tests for major cancers can save lives.
Investigators are randomizing 148,000 men and women to receive either a specified regimen of screening tests or only those screening tests recommended by their physicians. Women in the intervention group will receive an annual CA 125 II assay, chest x-ray, physician examination of the ovaries, transvaginal ultrasound, and sigmoidoscopy.