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FDA Gives Clearance to the First Cystic Fibrosis DNA test
May 10, 2005 - 9:18:00 AM, Reviewed by: Dr.
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"Clearance by the FDA of a genetic assay for cystic fibrosis provides a highly standardized product for laboratories that offers tremendous benefits to the genetic testing industry, physicians and to patients."
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By Tm Bioscience,
Tm Bioscience Corporation (Toronto, Ontario; TSX: TMC), a leader in the commercial genetic testing market, is pleased to announce that its Tag-It(TM) Cystic Fibrosis (CF) Kit is the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration (FDA) as an in vitro device (IVD) for diagnostic use in the United States.
This DNA based test is used to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens in order to determine CF carrier status in adults, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. Performance testing has established that the Tag-It(TM) CF Kit operates with 100% accuracy and greater than 99.9% reproducibility and precision.
"This clearance establishes Tm as a unique supplier of CF tests to our rapidly expanding customer base against such competitors as ABI (NYSE:ABI - News) and Third Wave (NASDAQ:TWTI - News)," said Greg Hines, President and CEO of Tm Bioscience. "The Tag-It(TM) Cystic Fibrosis Kit is the only CF testing system that has performance characteristics which have been established through extensive studies reviewed by the FDA. Having the first CF test and second multiplexed genetic test behind Roche's (RHHBF.PK) AmpliChip CYP450 to be cleared as an IVD, sets the regulatory pathway for other tests in our broad and growing pipeline and positions Tm as a leader in the commercial genetic testing market."
"Clearance by the FDA of a genetic assay for cystic fibrosis provides a highly standardized product for laboratories that offers tremendous benefits to the genetic testing industry, physicians and to patients." said Dr. Michael Watson, Executive Director, American College of Medical Genetics.
Cystic Fibrosis (CF) is the most common autosomal recessive disorder in the Caucasian population, with an incidence of approximately 1 in 3,200 live births. The Tag-It(TM) Cystic Fibrosis Kit simultaneously screens for the 23 cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations and 4 variants (polymorphisms), as recommended by the American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG) in 2004. In addition, the kit screens for 16 additional mutations prevalent in North America or the world.
Performance Results
The Tag-It(TM) Cystic Fibrosis Kit is sold with the following FDA cleared performance characteristics:
-Accuracy of the Tag-It(TM) CF Kit was established in a method comparison study using DNA sequencing as reference methods. Based on comparison of 2,924 genotyping calls for the 43 mutations and variants tested for by the Tag-It(TM) CF Kit, concordance between the Tag-It(TM) CF Kit and the reference tests was 100% (95% CI(equal sign)99.9% to 100%).
-Reproducibility was established as greater than 99.9% in a multi-site study by testing DNA samples obtained from the Coriell Institute for Medical Research (Camden, NJ) repository using three different lots and three operators.
-Precision was tested using synthetic positive controls representing all potential genotyping calls for all 43 mutations and variants tested for by the Tag-It(TM) CF Kit. Overall, study results showed that all genotyping calls that can be made by the Tag-It(TM) CF Kit were made correctly and reproducibly under the evaluated conditions with a precision of greater than 99.9%.
The kit is not indicated for fetal diagnostic, pre-implantation testing or for stand-alone diagnostic purposes.
About Tag-It(TM) reagents and genetic tests
Tm Bioscience's product menu is focused in the fields of human genetic disorders, pharmacogenetics and infectious disease. The Company has commercialized Analyte Specific Reagents(x) and a series of Tag-It(TM) tests(xx) for a variety of genetic disorders. All genetic tests from Tm Bioscience are based on the Tag-It(TM) Universal Array platform, which utilizes a proprietary universal tag system that allows for easy optimization, product development and expansion. Assays from Tm operate on the Luminex xMAP� system, a well-established bead based instrument. Combined, the Universal Array and Luminex instrument enable the rapid production of flexible, high-throughput, low-cost DNA-based tests. 
- U.S. Food and Drug Administration (FDA)
www.tmbioscience.com
(x)Analyte Specific Reagent. Analytical and performance characteristics are not established.
(xx) For Investigational Use Only. The performance characteristics of these products have not been established.
About Tm Bioscience - Putting the Human Genome to Work(TM)
Tm Bioscience is a DNA-based diagnostics company developing a suite of genetic tests. Tm Bioscience's product pipeline includes tests for genetic disorders, drug metabolism, and infectious diseases. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be found at www.tmbioscience.com.
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