FDA Approves Assay That May Help Detect the Progression of Testicular Cancer 


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Abbott announced that the ARCHITECT AFP assay, which may help doctors detect the progression of testicular cancer as well as serious birth defects, has received FDA approval.

The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay for the quantitative determination of alpha-fetoprotein (AFP) in human serum or plasma to aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer; and human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects.

AFP and Testicular Cancer

Men with nonseminomatous germ cell tumors, have elevated AFP levels present in their bloodstream, and blood tests to measure AFP can be used to evaluate responses to treatment. By monitoring disease progression and seeking treatment when necessary, testicular cancer can be a highly treatable and usually curable cancer.

“The ARCHITECT AFP assay is a valuable tool that will help physicians obtain reliable measurements of this protein for use in guiding critical patient treatment decisions,” said Brian Blaser, Executive Vice President, Diagnostics Products, Abbott.

The new assay runs on Abbott’s ARCHITECT i2000, i2000SR, ci8200, and ci16200 analyzers, and is available in the United States, CE-marked, and nonregulated countries. ■



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