Abbott announced that the FDA has approved Architect AFP, a test to help detect serious birth defects and the progression of testicular cancer. Alpha-fetoprotein (AFP) is a biomarker that can identify the progress of diseases or conditions as well as evaluate the effectiveness of treatments.

Regarding neural tube defects, AFP is thought to leak directly from the fetus into the mother’s amniotic fluid. When the tube fails to close, high levels of AFP are present in the mother’s blood. This test can help determine if a woman is carrying a fetus affected with birth defects such as anencephaly and spina bifida.

In nonseminoma germ cell cancer, a specific type of testicular cancer, elevated AFP levels are present in the patient’s bloodstreams.  This test can be used to evaluate response to treatment and monitor disease progression.

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

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