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Quest Diagnostics ClariSure(TM) Postnatal Molecular Test Receives Clinical Laboratory Approval from New York State
Date:3/17/2009

to provide appropriate schooling and social support to their infants and children."

Scientists at Nichols Institute have validated the ClariSure test's ability to use a single blood specimen to identify chromosomal abnormalities associated with dozens of disorders, including Down, cri du chat, DiGeorge and Williams syndromes. A positive result may be confirmed using a fluorescence in situ hybridization (FISH) methodology.

aCGH technologies compare and contrast a specimen's DNA to the DNA of a healthy individual to identify, at a high resolution, extra or missing genetic material in the specimen. These technologies can detect a proportion of additional abnormalities even in patients who have already had extensive cytogenetic and/or FISH testing. aCGH tests are also more efficient, as multiple tests are required to generate the same amount of information produced from one microarray-based test. Chromosome abnormalities, such as extra copies of chromosomes and other copy number changes, have been implicated in some types of mental retardation, developmental disorder and congenital anomalies, as well as in autism and autism spectrum disorders.

In the U.S., the clinical laboratory testing services are regulated under the federal Clinical Laboratory Clinical Laboratory Improvement Amendments (CLIA). Laboratory-developed tests must fulfill CLIA requirements, including validation studies, before they can be introduced to their markets. New York has the only state licensure program which requires pre-approval of a laboratory's validation procedure prior to testing of patient samples. Under the state program, laboratory-developed tests must be able to demonstrate they perform as intended, according to clinical and analytical validation studies, before they can be used to conduct testing on specimens collected in the state.

Quest Diagnostics Nichols Institute will provide information about the ClariSure pos
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SOURCE Quest Diagnostics Incorporated
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