CHEO Leverages Luminex Technology.

Publication: Health & Beauty Close-Up
Date: Monday, June 30 2008

The Ontario Newborn Screening Program, located at the Children's Hospital of Eastern Ontario (CHEO), recently announced that it 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 noted that it achieved the milestone on April 9, when it began offering genetic testing for Cystic Fibrosis (CF) using the xTAG Cystic Fibrosis Kit developed by Luminex Corp.

The Company said 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) 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, congenital adrenal hyperplasia 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 Cystic Fibrosis Kit, as noted in the release.

"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."

According to the Company, CF is the most common autosomal recessive 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. 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 (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 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 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 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 (ACMG) and American College of Obstetricians and Gynecologists (ACOG) 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 percent) test that provides superior mutation coverage for carrier screening in adults and as an aid to diagnosis in newborns, as noted in the release.

Luminex Corp. develops, manufactures and markets proprietary biological testing technologies with applications throughout the diagnostic and life sciences industries.

((Comments on this story may be sent to newsdesk@closeupmedia.com))

((Distributed via M2 Communications Ltd - http://www.m2.com))

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CHEO Leverages Luminex Technology.

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