Abbott has announced that the ARCHITECT AFP test, which may help doctors detect fetal birth defects and the progression of testicular cancer, has received U.S. Food and Drug Administration (FDA) approval. The new assay runs on Abbott’s fully automated ARCHITECT i2000, i2000SR, ci8200, and ci16200 analyzers, and is available in the United States, CE marked, and non-regulated countries.
Biomarkers, such as alpha-fetoprotein (AFP), are substances in the body that physicians can measure to identify the progress of diseases or conditions and to evaluate the effectiveness of treatments. AFP has unique traits that can help doctors detect both health issues.
Neural tube defects (NTDs) are serious fetal birth defects of the brain and spine that occur very early in development. When the neural tube fails to close properly, AFP is thought to leak directly from the fetus into the mother’s amniotic fluid, causing unexpectedly high levels of AFP in the mother’s blood. A blood test that measures AFP can help doctors determine if a woman is carrying a fetus affected with birth defects, such as anencephaly and spina bifida. Treatments for NTDs focus on closing the defect with surgery (including surgery before birth) and treating or addressing related symptoms such as excess fluid in the brain and bladder and bowel problems.
Men with one type of testicular cancer, called nonseminoma germ cell, 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 highly treatable and usually curable. Learn more from Abbott.