TORONTO, Jan. 11 /PRNewswire-FirstCall/ - Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced that its Tag-It(TM) Cystic Fibrosis (CF) Kit now has the CE Mark (“Conformite Europeene”), allowing the genetic test to be marketed for diagnostic purposes in the European Union and other countries that recognize the CE Mark.
“Having the CE Mark on our Tag-It(TM) CF test expands our reach into the European market for CF testing and further asserts our leadership position in the clinical genetic testing market,” said Greg Hines, President and CEO of Tm Bioscience.
“A proven, highly accurate and affordable cystic fibrosis molecular test is needed for the European market for carrier screening and as a tool for diagnosis of newborns,” said Dr. Jeremy Bridge-Cook, Vice-President, Marketing and Business Development. “The Tag-It(TM) CF Assay has a demonstrated track record of meeting this need in the North American market and we look forward to providing European customers these same capabilities.”
The Tag-It(TM) Cystic Fibrosis Kit is used to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood or blood spot 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.
The Tag-It(TM) Cystic Fibrosis (CF) Kit is also 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.
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 39 cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations and 4 variants (polymorphisms) prevalent worldwide.
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. 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(R) system (Luminex Corporation, Austin, Texas), 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. Tm Bioscience is located in Toronto, Ontario. Additional information about Tm Bioscience can be found at 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 Forward-Looking Statements
This press release contains forward-looking statements, which by their nature necessarily involve risk and uncertainties that could cause the actual results to differ materially from those contemplated by such statements. Tm Bioscience considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions readers that these assumptions may ultimately prove to be incorrect due to certain risks and uncertainties including, without limitation, the difficulty of predicting regulatory approvals, market acceptance and demand for new products, the availability of appropriate genetic content and other materials required for Tm Bioscience’s products, Tm Bioscience’s ability to manufacture its products on a large scale, the protection of intellectual property connected with genetic content, the impact of competitive products, currency fluctuations, risks associated with Tm Bioscience’s manufacturing facility and any other similar or related risks and uncertainties. If any of these risks or uncertainties were to materialize, or if assumptions underlying the forward-looking statements of management were to prove incorrect, actual results of Tm Bioscience could vary materially from those that are expressed or implied by these forward-looking statements. Tm Bioscience disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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CONTACT: INVESTOR RELATIONS: Tm Bioscience - Canada, James Smith, TheEquicom Group, Tel.: (416) 815-0700, Email: jsmith@equicomgroup.com; TmBioscience - U.S.: Sharon Weinstein, Account Supervisor, Euro RSCG LifeNRP, Tel.: (212) 845-4271, Email: sharon.weinstein@eurorscg.com; To requesta free copy of this organization’s annual report, please go tohttp://www.newswire.ca and click on Tools for Investors.