Children's Hospital of Eastern Ontario Achieves Newborn Screening Mandate with Luminex Technology.Implementation of xTAG(TM) Cystic Fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. Kit Completes Two-Year Effort to Identify 28 Genetic Diseases in Children More Quickly OTTAWA & AUSTIN, Texas -- The Ontario Newborn Screening newborn screening Neonatology The analysis of a neonate's blood for metabolic or other disorders to prevent mental retardation, disability or death Program, located at the Children's Hospital of Eastern Ontario The Children's Hospital of Eastern Ontario (CHEO) is a major university teaching children's hospital located at 401 Smyth Road, Ottawa, Canada (Tel (613) 737-7600). It is affiliated with The Ottawa Hospital and the University of Ottawa. (CHEO CHEO Children's Hospital of Eastern Ontario ), has accomplished the Ministry of Health and Long-Term Care's mandate to screen all babies born in Ontario for 28 different rare genetic disorders. CHEO achieved this milestone on April 9, 2008 when it began offering genetic testing Genetic Testing Definition A genetic test examines the genetic information contained inside a person's cells, called DNA, to determine if that person has or will develop a certain disease or could pass a disease to his or her offspring. for Cystic Fibrosis (CF) using the xTAG[TM] Cystic Fibrosis Kit developed by Luminex Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : LMNX). From 1978 through 2005, newborn screening in Ontario was virtually unchanged. In November 2005, the Ministry announced that it would be expanding newborn screening in the province and centralizing testing at CHEO in Ottawa. The Ontario Newborn Screening Program (ONSP ONSP Optical Network Signaling Protocol ) at CHEO was designed to ensure that all babies born in Ontario have access - from day one - to the most accurate and effective healthcare possible. As part of the program, blood samples from all babies born in Ontario are sent to the ONSP and screened for metabolic and genetic disorders including sickle cell anemia sickle cell anemia n. A chronic, usually fatal inherited form of anemia marked by crescent-shaped red blood cells, occurring almost exclusively in Blacks, and characterized by fever, leg ulcers, jaundice, and episodic pain in the joints. , congenital adrenal hyperplasia Congenital Adrenal Hyperplasia Definition CAH is a genetic disorder characterized by a deficiency in the hormones cortisol and aldosterone and an over-production of the hormone androgen, which is present at birth and affects sexual development. and cystic fibrosis. The expansion of newborn screening in Ontario officially began in April 2006 when the ONSP was launched at CHEO, offering testing for three rare genetic diseases. CHEO extended its test offerings for the next two years, finally achieving the 28-test mandate this April with CF testing using the xTAG[TM] Cystic Fibrosis Kit. "The Luminex CF kit provides a robust, user-friendly system to test a large number of samples for a broad panel of clinically relevant CF mutations, allowing us to screen more than a hundred samples every week from newborn babies that have been identified as being at high risk for having CF," said Dr. Pranesh Chakraborty, pediatrician and laboratory director for the Ontario Newborn Screening Program at CHEO. "This, in turn, means that babies who have CF can be diagnosed earlier and their health can be improved by starting treatment at an earlier age." CF is the most common autosomal recessive Autosomal recessive A pattern of inheritance in which both copies of an autosomal gene must be abnormal for a genetic condition or disease to occur. An autosomal gene is a gene that is located on one of the autosomes or non-sex chromosomes. disorder in the Caucasian population. It is estimated that one in every 3,600 children born in Ontario is affected with the disease. Early detection and treatment of CF has been shown to reduce therapeutic needs, lower rates of complications, and increase life expectancy Life Expectancy 1. The age until which a person is expected to live. 2. The remaining number of years an individual is expected to live, based on IRS issued life expectancy tables. . Late diagnosis of the disease is frequently associated with chronic lung infections and compromised growth. CF screening begins by assessing an infant's blood IRT IRT Item Response Theory IRT In Regard To IRT Incident Response Team IRT In Reference To IRT In Regards To IRT Icing Research Tunnel (wind tunnel) IRT Interborough Rapid Transit (immunoreactive trypsinogen) level from a dried blood spot sample obtained from a heel prick. A high IRT suggests possible CF and requires further testing. Those samples showing an IRT level above the 96th percentile are then tested with the Luminex xTAG[TM] Cystic Fibrosis Kit, which simultaneously screens for the 39 most common CF gene mutations and 4 variants. Within the first six weeks of genetic testing for CF, CHEO's Newborn Screening Program conducted 826 tests using the Luminex test. From that group, 47 babies were identified as being at high risk for having CF and referred to a treatment centre for a follow up assessment with a specialist. "Through its newborn screening mandate, the government of Ontario The Government of Ontario refers to the provincial government of the province of Ontario. Its powers and structure are set out in the Constitution Act, 1867. In modern Canadian use, the term "government" refers broadly to the cabinet of the day, elected from the Legislative has recognized the significant health benefits that early detection affords people who are diagnosed with CF," says Jeremy Bridge-Cook, Vice President of Luminex Molecular Diagnostics. "We salute the Newborn Screening Program at CHEO for having accomplished its ambitious goal and are honored that Luminex's cystic fibrosis kit has aided in its endeavor. Knowing that our work is helping Ontario families keep their children healthy really brings home Luminex's mission to improve the health, safety, and quality of life of people around the world." Luminex's xTAG[TM] Cystic Fibrosis Kit simultaneously screens for 39 common CF gene mutations and 4 variants, including the 23 CFTR gene mutations and 4 variants (polymorphisms) that were recommended by the American College of Medical Genetics The American College of Medical Genetics (ACMG) is an organization composed of biochemical, clinical, cytogenetic, medical and molecular geneticists, genetic counselors and other health care professionals committed to the practice of medical genetics. (ACMG ACMG American College of Medical Genetics ACMG Association of Canadian Mountain Guides ACMG Air Cargo Management Group ) and American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S. (ACOG ACOG American College of Obstetricians and Gynecologists. ACOG American College of Obstetricians & Gynecologists ) in 2004, plus 16 of the world's most common and North American-prevalent mutations. With validated performance criteria, the CF Kit is a highly accurate and reproducible (99.9%) test that provides superior mutation coverage for carrier screening in adults and as an aid to diagnosis in newborns. In May 2005, the xTAG[TM] Cystic Fibrosis Kit became the first multiplexing assay to be cleared for diagnostic use by the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). It received CE mark certification for sale in Europe in December 2005, and was approved by Health Canada in July 2006. Luminex's future plans for advances in CF screening include seeking approval in the US, Canada, and Europe for a second CF genotyping assay which will allow detection of more than 39 mutations and will increase the mutation coverage rates within different ethnic groups, especially within the Hispanic and African-American populations. About the Ontario Newborn Screening Program To learn more about the Ontario Newborn Screening Program, Cystic Fibrosis, or other genetic disorders that are part of the newborn screening panel, visit www.newbornscreening.on.ca About Luminex Corporation Luminex Corporation develops, manufactures and markets proprietary biological testing technologies with applications throughout the diagnostic and life sciences industries. The Company's xMAP[R] multiplex solutions include an open-architecture, multi-analyte technology platform that delivers fast, accurate and cost-effective bioassay Bioassay A method for the quantitation of the effects on a biological system by its exposure to a substance, as well as the quantitation of the concentration of a substance by some observable effect on a biological system. 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 technology is sold worldwide and is already in use in leading clinical laboratories as well as major pharmaceutical, diagnostic and biotechnology companies. Further information on Luminex Corporation or xMAP technology can be obtained at www.luminexcorp.com. Statements made in this release that express Luminex' 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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' actual results or performance to differ materially include risks and uncertainties relating to, among others, Luminex' ability to execute on the growth potential of its proprietary xMAP Technology-based products and platforms, Luminex' ability to continue to develop new products that address unmet clinical and customer needs in growth market segments, Luminex' ability to expand its assay product line and obtain regulatory approvals of any new products, market demand and acceptance of Luminex' 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' ability to scale manufacturing operations and manage operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , 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, or selected assets into our consolidated business operations, including the ability to recognize the benefits of our acquisitions, as well as the risks discussed under the heading "Risk Factors" in Luminex' 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' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. |
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