AUSTIN, Texas and MILWAUKEE, March 2 /PRNewswire/ -- 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.
Cindy R. WalkerPeach, Ph.D.
Director, Development & cGMP Operations
Ambion Diagnostics of Ambion, Inc.
Brian K. DuChateau, Ph.D., D(ABMLI)
Director, Product Development, Diagnostic Laboratories
The Blood Center of Southeastern Wisconsin
(414) 937 6379
CONTACT: Cindy R. WalkerPeach, Ph.D., Director, Development & cGMPOperations of Ambion Diagnostics, +1-512-651-0200; or Brian K. DuChateau,Ph.D., D(ABMLI), Director, Product Development, Diagnostic Laboratories of TheBlood Center of Southeastern Wisconsin, +1-414-937-6379