Test aiding diagnosis of mental retardation, birth defects, and autism
spectrum and developmental disorders now approved for use on patients in New
York
MADISON, N.J., March 17 /PRNewswire-FirstCall/ -- Quest Diagnostics
Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing,
information and services, today announced that its ClariSure(TM)
microarray-based comparative genomic hybridization (aCGH) postnatal test is
now available for testing on patients in the state of New York. With licensure
by the State Department of Health Clinical Laboratory Evaluation Program,
Quest Diagnostics operates one of only three laboratories in the U.S. approved
to perform aCGH testing on postnatal samples collected on patients in New
York. The state has approved the use of the ClariSure aCGH postnatal test as
an aid in detecting copy-number chromosomal abnormalities implicated in dozens
of medical conditions, including mental retardation, birth defects, and autism
spectrum and developmental disorders, which conventional laboratory tests may
fail to detect.
"With approval by New York State, our advanced ClariSure test has
demonstrated that it fulfills test validation requirements widely regarded as
among the most rigorous in the lab industry," said Charles (Buck) Strom, M.D.,
Ph.D., medical director of the genetic testing center of Quest Diagnostics
Nichols Institute, the esoteric testing laboratory and research and
development center of Quest Diagnostics. "Since its launch in mid-2007,
physicians outside of New York have used our ClariSure test to identify the
genetic etiology of congenital anomalies, autism and other disorders for
dozens of patients whose conditions had eluded prior diagnostic efforts. We
look forward to providing broader access to our ClariSure test, so that more
parents have the diagnostic insights they need 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 postnatal test at its exhibit at the 2009 American College of
Medical Genetics (ACMG) conference in Tampa, Florida. The exhibit will be open
from March 26 to March 28.
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing,
information and services that patients and doctors need to make better
healthcare decisions. The company offers the broadest access to diagnostic
testing services through its network of laboratories and patient service
centers, and provides interpretive consultation through its extensive medical
and scientific staff. Quest Diagnostics is a pioneer in developing innovative
diagnostic tests and advanced healthcare information technology solutions that
help improve patient care. Additional company information is available at
www.questdiagnostics.com.
The statements in this press release which are not historical facts may be
forward-looking statements. Readers are cautioned not to place undue reliance
on forward-looking statements, which speak only as of the date that they are
made and which reflect management's current estimates, projections,
expectations or beliefs and which involve risks and uncertainties that could
cause actual results and outcomes to be materially different. Risks and
uncertainties that may affect the future results of the company include, but
are not limited to, adverse results from pending or future government
investigations, lawsuits or private actions, the competitive environment,
changes in government regulations, changing relationships with customers,
payers, suppliers and strategic partners and other factors discussed in
"Business" in Part I, Item 1, "Risk Factors" and "Cautionary Factors that May
Affect Future Results" in Part I, Item 1A, "Legal Proceedings" in Part I, Item
3, "Management's Discussion and Analysis of Financial Condition and Results of
Operations" in Part II, Item 7 and "Quantitative and Qualitative Disclosures
About Market Risk" in Part II, Item 7A in the company's 2008 Annual Report on
Form 10-K and other items throughout the Form 10-K and Current Reports on Form
8-K.
SOURCE Quest Diagnostics Incorporated
-0- 03/17/2009
/CONTACT: Media, Wendy Bost, +1-973-520-2800, or Investors, Laure Park,
+1-973-520-2900/
/Web Site: http://www.questdiagnostics.com /
(DGX DGX)
CO: Quest Diagnostics Incorporated
ST: New Jersey
IN: HEA BIO MTC
SU: TRI SVY
PR
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4573 03/17/200910:00 EDThttp://www.prnewswire.com