New Abbott Test Can Help Doctors Detect the Presence of Two Important Health Issues
ABBOTT PARK, Ill., /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the ARCHITECT AFP test, which may help doctors detect serious birth defects and the progression of testicular cancer, received U.S. Food and Drug Administration (FDA) approval. Biomarkers, such as alpha-fetoprotein (AFP), are substances in the body that physicians can measure to identify the progress of diseases or conditions as well as to evaluate the effectiveness of treatments. AFP has unique traits that help doctors detect two very different health issues: fetal birth defects and the progression of testicular cancer.
Neural tube defects (NTDs) are serious fetal birth defects of the brain and spine that occur very early in development. When the neural tube, a structure that develops into the brain and spinal cord, 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 (the absence of a large part of the brain and the skull) and spina bifida (the incomplete closing of the backbone and spinal canal). 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 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 , executive vice president, Diagnostics Products, Abbott. "Abbott is pleased to offer this important assay to our customers to positively affect patient care."
The new assay runs on Abbott's fully-automated ARCHITECT 2000, 2000SR, 8200, and 16200 analyzers, and is available in , CE marked, and non-regulated countries.
The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of alpha-fetoprotein (AFP) in:
Abbott is a global leader in diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 22,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs.
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
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