FDA OKs test for detecting testis Ca progression

April 1, 2013

Abbott has announced that the ARCHITECT AFP test, which may help physicians detect the progression of testicular cancer, received FDA approval.

Abbott has announced that the ARCHITECT AFP test, which may help physicians detect the progression of testicular cancer, received FDA approval.

The approval also includes the assay’s use as an aid in the detection of certain fetal birth defects.

The ARCHITECT AFP test measures levels of the biomarker alpha-fetoprotein (AFP) in serum. Men with nonseminomatous testicular cancer have elevated AFP levels present in their bloodstreams. 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, Abbott said in a statement.

"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 of Abbott.

The new assay runs on Abbott’s automated ARCHITECT i2000, i2000SR, ci8200, and ci16200 analyzers.

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