First commercial test available nationally
LYNDHURST, N.J., Aug. 30 /PRNewswire-FirstCall/ -- A molecular diagnostic
test that detects chromosome abnormalities associated with 85 developmental
disorders affecting children now is commercially available from a national
diagnostic testing company, affording testing and reimbursement by leading
health plans across the U.S. Quest Diagnostics Incorporated (NYSE: DGX), the
nation's leading provider of diagnostic testing, information and services,
developed its ClariSure(TM) microarray-based comparative genomic hybridization
(CGH) test to enable physicians to use results obtained from a single blood
test to diagnose patients with mental retardation and dozens of other
disorders, including Down, cri du chat, DiGeorge and Williams syndromes.
"Our ClariSure test is an important advance in diagnostic testing
resulting from the Human Genome Project(1). This project gave us the map of
the human genome and knowledge of DNA required to develop and commercialize
our assay," 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.
"Using today's conventional analytical techniques, physicians may
inadvertently miss the genetic cause of a patient's developmental disorder.
Our ClariSure test is a powerful tool that physicians can use to produce an
accurate diagnosis more quickly."
The ClariSure test is a laboratory-developed assay that uses proprietary
technologies from Nichols Institute as well as licensed methodologies.
Scientists at Nichols Institute have validated the ClariSure test's ability to
use a single blood specimen to identify chromosomal abnormalities associated
with up to 85 developmental disorders. A positive result may be confirmed
using a licensed fluorescence in situ hybridization (FISH) methodology. The
company expects to provide test results from its ClariSure assay to physicians
within five days of receiving a specimen at a Quest Diagnostics laboratory.
"While CGH microarrays often are used for research purposes, the
considerable expertise and development required to commercialize these
technologies has limited their use for diagnostic testing," said Joyce
Schwartz, M.D., vice president and chief laboratory officer. "Our ClariSure
assay bridges the gap between scientific research and real-world testing,
affording physicians with a faster technique for diagnosing patients suspected
of having a developmental disorder. With better diagnostic insights, parents
can provide their child with appropriate schooling and social support, and
understand the likelihood that other offspring may have the same disorder."
Quest Diagnostics owns the intellectual property underlying its microarray
technology, which is used to analyze information contained within an
individual's genetic makeup. CGH microarray 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 substantial proportion of additional abnormalities
even in patients who have already had extensive cytogenetic and/or
fluorescence in situ hybridization testing.(2) CGH microarray technologies are
also more efficient, as multiple FISH tests are required to generate the same
amount of information produced from one microarray-based test.
Quest Diagnostics' ClariSure test will be first introduced to physicians
at pediatric and children's hospitals, with an emphasis on pediatricians,
geneticists and pediatric neurologists.
Future ClariSure Test Applications
Nichols Institute also is developing additional ClariSure tests to
identify chromosome abnormalities associated with hematological malignancies,
such as Leukemia. The ClariSure test is able to detect abnormalities even if
cell division has yet to occur, which may enable it to detect abnormalities
that suggest the presence of cancer in a higher percentage of patients than is
possible using conventional cytogenetic and FISH techniques. The company
expects to begin to provide ClariSure assays for hematological malignancies to
hospital physicians, including oncologists and hematologists, by the end of
this year.
About Mental Retardation
Mental retardation and developmental delay are characterized by
significant limitations in intellectual functioning and impaired conceptual
and social development. Causes of mental retardation range from chromosome
abnormalities to pre-natal environmental conditions. Array CGH techniques
will detect chromosome abnormalities in as many as five percent to 17 percent
of individuals with mental retardation.(3) With an accurate diagnosis,
children are more likely to receive counseling, education and other support
appropriate for their condition.
About Quest Diagnostics
Quest Diagnostics is the 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 national 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 new diagnostic tests and advanced healthcare information technology
solutions that help improve patient care. Additional company information is
available at www.questdiagnostics.com.
This communication contains certain forward-looking statements. These
forward-looking statements, which may include, but are not limited to,
statements concerning the proposed acquisition, are based on management's
current expectations and estimates and involve risks and uncertainties that
could cause actual results or outcomes to differ materially from those
contemplated by the forward-looking statements. Certain of these risks and
uncertainties may include, but are not limited to the risks and uncertainties
described in the Quest Diagnostics Incorporated 2006 Form 10-K and subsequent
filings.
(1) The Human Genome Project was the international, collaborative research
program whose goal was the complete mapping and understanding of all
the genes of human beings. The full sequence was completed and
published in April 2003. Source: National Institutes of Health.
(2) Source: Journal of Pediatrics, 2006;149:98-102.
(3) Source: Shaffer and Bejjani, Cytogenet Genome Res 115:303-309 (2006).
SOURCE Quest Diagnostics
CONTACT:
Laure Park, Investors,
+1-201-393-5030,
or Wendy Bost, Media,
+1-201-393-5700,
both of Quest Diagnostics
Web site: http://www.questdiagnostics.com