New Abbott Test Can Help Doctors Detect the Presence of Two Important Health
ABBOTT PARK, Ill., March 28, 2013
ABBOTT PARK, Ill., March 28, 2013 /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.
AFP and Birth Defects^1, 2
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
AFP and Testicular Cancer^3, 4, 5
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 Brian Blaser, executive vice president, Diagnostics
Products, Abbott. "Abbott is pleased to offer this important assay to our
customers to positively affect patient care."
About the ARCHITECT AFP Assay
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.
The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay (CMIA)
for the quantitative determination of alpha-fetoprotein (AFP) in:
1.Human serum or plasma to aid in monitoring disease progression during the
course of disease and treatment of patients with nonseminomatous
2.Human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid
in the detection of fetal open neural tube defects (NTD). Test results
when used in conjunction with ultrasonography or amniography are a safe
and effective aid in the detection of fetal open NTD.
About Abbott Diagnostics
Abbott is a global leader in in vitro 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.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
^1 Burke, B. et al. Preventing Neural Tube Birth Defects: A Prevention Model
and Resource Guide. Department of Health and Human Services and the Centers
for Disease Control and Prevention. April 2009.
^2 Neural Tube Defects (NTDs) Overview. National Institute of Child Health and
Human Development, November 2012.
^3 Lange PH, McIntire KR, Waldmann TA, et al. Serum alpha fetoprotein and
human chorionic gonadotropin in the diagnosis and management of
nonseminomatous germ-cell testicular cancer. New England Journal of Medicine.
^4 Kohn J, Orr AH, McElwain TJ, et al. Serum-alpha-fetoprotein in patients
with testicular tumours. Lancet 1976; 2: 433-6.
^5 Testicular Cancer Treatment (PDQ^®): Health Professional Version. National
Cancer Institute. January 2012.
Contact: Media, Darcy Ross, +1-847-937-3655, Jessica Masuga, +1-847-935-0650,
Financial, Tina Ventura, +1-847-935-9390
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