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Ambion Diagnostics First Molecular
Test Adopted
by The Blood Center of Southeastern Wisconsin
Austin, TX and Milwaukee, WI,
March 2, 2005--Ambion Diagnostics, a division of Ambion, Inc. (Austin, TX) announces the adoption
of its first molecular genetic test, Signature(TM) CF 2.0 ASR, by The Blood
Center of Southeastern Wisconsin. The Signature CF 2.0 ASR, for the detection
of mutations in the gene associated with cystic fibrosis (CF), represents a
new generation of molecular diagnostic tests that brings simplicity and speed
to genetic testing. Cystic Fibrosis is one of the most common genetic disorders
in Caucasian populations, carried by about 1 in 29 individuals. CF is much
less frequent in Asian Americans (carried by 1 in 90), in African Americans
(1 in 65), and in Hispanic Americans (1 in 46). The American College of Obstetrics
and Gynecology (ACOG) now recommends that obstetrician-gynecologists make DNA
screening for cystic fibrosis available to all couples seeking preconception
or prenatal care--not just those with a personal or family history of carrying
the CF gene, as previously recommended. The Signature CF 2.0 ASR, adapted for
a bead array platform, can be used to identify 25 mutations and 6 variants
of the cystic fibrosis transmembrane conductance regulator (CFTR) gene. These
mutations represent the most common genetic mutations in North America and
include the mutations recommended by the American College of Medical Genetics
(ACMG). "As the one of the leading centers for molecular diagnostics and
genetic testing in Wisconsin, the addition of cystic fibrosis testing is an
important step in expanding the genetic services offered at the Blood Center
of Southeastern Wisconsin. Ambion Diagnostics' Signature CF 2.0 ASR has a reliable,
rapid and easy-to-use format that will enable us to deliver outstanding service
to the patients that we serve. In addition, the Signature Script software will
assist our laboratory in monitoring the quality control of this complex genetic
test," said Daniel Bellissimo Ph.D., Director of the Molecular Diagnostic
Laboratory at The Blood Center. "We are very pleased to work with an institution
that has the scientific expertise and excellent reputation as that of The Blood
Center of Southeastern Wisconsin. The signing of this agreement reinforces
Ambion Diagnostics' commitment to Molecular Diagnostics by providing reliable
and easy-to-use solutions for genetic testing," said Dr. Jeff Williams,
General Manager of Ambion Diagnostics.
About Ambion Diagnostics Ambion Diagnostics,
a division of Ambion, Inc., develops, manufactures and markets
innovative products to detect diseases and enable the development
of pharmaceuticals. It leverages the core technologies and
RNA expertise of Ambion's Research Product Division to provide
solutions for the clinical and healthcare industries. With
a commitment to quality, Ambion Diagnostics is QSR/ISO compliant
and FDA registered. In addition to its Signature CF 2.0 ASR
for cystic fibrosis mutation screening, the Company will
soon release an Ashkenazi Carrier Panel screening product
for the simultaneous detection of multiple genetic diseases
associated with Jewish Heritage.
About The Blood Center of Southeastern Wisconsin The Blood
Center of Southeastern Wisconsin is a multi-faceted, world-
renowned organization focused on diagnostic testing, blood
collection, treatment, and research. The Diagnostic Laboratories
develop and perform highly specialized tests on patient samples
from throughout the United States and the world. They include
genetic testing, matching potential organ donors and recipients,
detecting risk factors for cancer and heart disease, and
identifying various bleeding and clotting disorders. Customers
rely on The Blood Center Diagnostic Laboratories for expert
assistant to solve complicated clinical cases. The organization's
mission is to save patients' lives by providing diagnostic
testing, blood products, medical expertise and scientific
discovery.
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