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|Luminex Licenses Cystic Fibrosis Gene Patent From John Hopkins University|
"These genetic markers from John Hopkins are an important element in advancing the diagnosis and monitoring of cystic fibrosis," said Jeremy Bridge-Cook, Vice President of Luminex Molecular Diagnostics. "We are pleased to be able to provide our customers and distributors with the rights to these markers as part of our Tag-It(TM) Cystic Fibrosis Kit."
Cystic fibrosis (CF) is the most common autosomal recessive disorder in the Caucasian population. It is a chronic disease that affects the lungs and digestive system and can be found in more than 30,000 children and adults in the United States and 70,000 children and adults worldwide.
The Tag-It(TM) Cystic Fibrosis Kit aids in newborn screening and confirmatory CF diagnostic testing in newborns and children and can determine CF carrier status in adults. The 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. It also screens for 16 additional CFTR mutations prevalent in North America or the world.
The license from Johns Hopkins provides Tag-It(TM) CF Kit users and distributors rights to 4 mutations (549N, 551D, 553X, 559T) tested for in the kit and covers 2 mutations (553X and 551D) in the screening panel of 23 cystic fibrosis gene mutations recommended by ACMG and ACOG.
Performance testing has shown that the Tag-It(TM) CF Kit operates with 100 percent accuracy and greater than 99.9 percent reproducibility and precision. The 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 for diagnostic use in the United States. It has also received CE mark certification and Health Canada clearance, allowing the test to be marketed for diagnostic purposes in the European Union and Canada.
Luminex Molecular Diagnostics was created in March 2007 when Luminex acquired Tm Bioscience of Toronto, Canada. This division of Luminex Corporation specializes in DNA-based research and diagnostics and is focused specifically on the design, development, manufacture and commercialization of nucleic-acid based testing products for genetic testing, personalized medicine and infectious disease.
Luminex Corporation develops, manufactures and markets proprietary biological testing technologies with applications throughout the life sciences industry. The company's xMAP(R) system is an open-architecture, multi-analyte technology platform that delivers fast, accurate and cost-effective bioassay results to markets as diverse as pharmaceutical drug discovery, clinical diagnostics and biomedical research, including the genomics and proteomics research markets. The company's xMAP(R) technology is sold worldwide and is in use in leading research laboratories as well as major pharmaceutical, diagnostic and biotechnology companies. Further information on Luminex Corporation or xMAP(R) can be obtained on the Internet at http://www.luminexcorp.com.
Statements made in this release that express Luminex's or management's intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. The words "believe," "expect," "intend," "estimate," "anticipate," "will," "could," "should" and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results or performance could differ materially from those anticipated or projected in such forward-looking statements. Factors that could cause Luminex's actual results or performance to differ materially include risks and uncertainties relating to, among others, market demand and acceptance of Luminex's products, the Company's dependence on strategic partners for development, commercialization and distribution of products, concentration of the Company's revenue in a limited number of strategic partners, fluctuations in quarterly results due to a lengthy and unpredictable sales cycle and bulk purchases of consumables, Luminex's ability to scale manufacturing operations and manage operating expenses, gross margins and inventory levels, potential shortages of components, competition, the timing of regulatory approvals, the implementation, including any modification, of the Company's strategic operating plans, risks and uncertainties associated with implementing our acquisition strategy and the ability to integrate acquired companies, including Tm Bioscience Corporation ("Tm"), or selected assets into our consolidated business operations, including the ability to recognize the benefits of our acquisitions, the failure of the Tm acquisition to close for any reason, including the failure to obtain the Tm stockholders' approval or the occurrence of any event or circumstance that could give rise to a termination of the merger agreement, as well as the risks discussed under the heading "Risk Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward-looking statements contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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