360° Coverage : FDA OKs mental disability blood test for infants

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FDA OKs mental disability blood test for infants

Jan 17 2014, 2:54pm CST | by

FDA approves novel genetic test that screens infants for predictors of mental handicaps WASHINGTON (AP) — The Food and Drug Administration on Friday cleared a first-of-a-kind blood...

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32 weeks ago

FDA OKs mental disability blood test for infants

Jan 17 2014, 2:54pm CST | by

FDA approves novel genetic test that screens infants for predictors of mental handicaps

WASHINGTON (AP) — The Food and Drug Administration on Friday cleared a first-of-a-kind blood test that can help diagnose mental disabilities in babies by analyzing their genetic code.

The laboratory test from Affymetrix detects variations in patients' chromosomes that are linked to Down syndrome, DiGeorge syndrome and other developmental disorders. About 2 to 3 percent of U.S. children have some sort of intellectual disability, according to the National Institutes of Health.

The test, known as the CytoScan Dx Assay, is designed to help doctors diagnose children's disabilities earlier and get them appropriate care and support. It is not intended for prenatal screening or for predicting other genetically acquired diseases and conditions, such as cancer.

While there are already genetic tests used to detect conditions like Down's syndrome, doctors usually have to order them individually and they can take several days to develop. Pediatricians said Friday that Affymetrix's test should offer a faster, more comprehensive screening approach. Dr. Annemarie Stroustrup stressed that such tests are generally only used after children exhibit certain physical or behavioral signs that suggest a disorder.

"When there's something about the child that strikes us as unusual or pointing to a potential genetic disease, that's when we would use this testing," said Stroustrup, an assistant professor of pediatrics at Mount Sinai Hospital in New York. "This is not a screening test to be done on all newborns to predict how they are going to do in school when they are 5."

Currently hospitals in all 50 states are required to screen newborns for at least 29 disorders that can be detected though laboratory testing, including sickle cell anemia and cystic fibrosis. Generally those tests pickup irregularities in metabolism, not genetic variations. The mandatory screening program, begun a half-century ago, is considered one of the nation's most successful public health programs.

The FDA said it approved the new test based on studies showing it accurately analyzes a patient's entire genome and can accurately spot variations associated with intellectual disabilities.

Affymetrix Inc. is based in Santa Clara, Calif. Shares of the company declined 17 cents to $9.31 in afternoon trading.

Source: AP Business

 
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2 days ago

Khazanah throws MAS RM6b lifeline

Aug 29 2014 5:01pm CDT | Source: Business Times Singapore

August 30, 2014 1:15 AMKHAZANAH Nasional will inject RM6 billion (SS$2.4 billion) over three years to resuscitate loss-making Malaysia Airlines (MAS) under a recovery plan that includes even an Act of Parliament. Other key moves are migrating its operations, assets and liabilities to a new company (NewCo) and slashing the workf ...
Source: Business Times Singapore   Full article at: Business Times Singapore
 

 
Update
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3 days ago

MAS posts loss of RM307m for Q2

Aug 28 2014 5:00pm CDT | Source: Business Times Singapore

August 29, 2014 1:13 AMMALAYSIA Airlines (MAS) registered a loss of RM307 million (S$122 million) for the second quarter to end-June, but warned of worse to come in the second half when the "full financial impact of the double tragedies of MH370 and MH17" ...
Source: Business Times Singapore   Full article at: Business Times Singapore
 

 

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