- Test is Easy for Patients to Use, Non-Invasive, Sensitive and Specific -
TETERBORO, N.J., Aug. 7 /PRNewswire-FirstCall/ -- Quest Diagnostics
Incorporated (NYSE: DGX), a leading provider of cancer screening and
diagnostic testing, information and services, today announced that it has
begun to offer InSure(TM), an FDA-cleared fecal immunochemical test to detect
the presence of blood in stool samples. The test is intended to help
physicians screen for colorectal cancer at an early stage in patients who are
at average risk. Earlier this year, Quest Diagnostics and Enterix Inc., a
privately held colorectal cancer screening company, announced that they had
entered into an agreement for Quest Diagnostics to offer InSure.
"InSure meets the critical need for a broad-based colorectal cancer
screening test," said Joyce Schwartz, M.D., Vice President and Chief
Laboratory Officer of Quest Diagnostics. "It is sensitive, specific and easy
for patients to use."
"Increasing compliance with screening guidelines is the key to reducing
the number of cases of colorectal cancer, which is a preventable disease,"
noted Jack Mandel, Ph.D., M.P.H., Chairman of the Department of Epidemiology
at the Emory University Rollins School of Public Health and lead investigator
for the definitive clinical trial of guaiac-based fecal occult blood tests.
"InSure offers physicians a screening tool that has been shown to have greater
compliance than guaiac-based fecal occult blood tests."
InSure is a more effective alternative to guaiac-based fecal occult blood
testing because it is specifically designed to detect human hemoglobin only
from lower gastrointestinal bleeding, from sources such as the colon and
rectum, without requiring the patient to observe dietary and medicinal
restrictions. In addition, studies indicate that InSure provides 87%
sensitivity(1) for colorectal cancer detection and 97.8% specificity.
The American Cancer Society's 2003 guidelines for colorectal cancer
screening cite immunochemical tests' advantages over guaiac-based fecal occult
blood tests. Based on a recent review(2) of various colorectal cancer
screening technologies by The American Cancer Society's (ACS) Colorectal
Cancer Screening Advisory Group, the ACS's Recommendations for Screening and
Surveillance for the Early Detection of Adenomatous Polyps and Colorectal
Cancer for 2003 now include the statement: "In comparison with guaiac-based
tests for the detection of occult blood, immunochemical tests are more-patient
friendly, and are likely to be equal or better in sensitivity and
specificity." The Group also noted that " ... recent studies of InSure
combined with previously published reports on the performance of
immunochemical tests for stool occult blood provide a persuasive argument that
these tests offer enhanced specificity in colorectal cancer screening compared
with guaiac-based testing."
The new InSure technology provides uncomplicated specimen collection that
is easy for patients to use at home. Unlike other colorectal cancer screening
technologies, InSure is non-invasive and it requires no handling of fecal
matter. To date, guaiac-based fecal occult blood testing has been the
cornerstone of early colorectal cancer screening. Specimen collection for
guaiac-based fecal occult blood tests has proved awkward and embarrassing for
patients in the past and has been an impediment to patient adherence.
The current rate of patient adherence with recommended colorectal cancer
screening guidelines -- using any method -- is lower than for screening tests
for breast, cervical or prostate cancers. It is estimated that only 33% of
Americans over the age of 50 have been screened for colorectal cancer by fecal
occult blood testing within the past two years(3) -- versus 84% of American
women over the age of 45 who have been screened for cervical cancer by Pap
testing within the past three years.(4) For the 80 million people over the
age of 50 who are of average risk, the American Cancer Society recommends
annual colorectal cancer screenings. If detected and treated at an early
stage, the 5-year relative survival rate for colorectal cancer is 90%.
"We are confident that InSure will overcome the current challenge of
patient non-compliance associated with traditional testing methods and improve
the chances of detecting colorectal cancer in more patients at an early and
treatable stage," said Dr. Schwartz.
Physicians and patients who are interested in learning more about InSure
may call 800-531-3681, ext. 10, or may visit the InSure website at
www.insurefobt.com.
About Quest Diagnostics
Quest Diagnostics Incorporated is the nation's leading provider of
diagnostic testing, information and services, providing insights that enable
healthcare professionals to make decisions that improve health. The company
offers the broadest access to diagnostic testing services in the United States
through its national network of laboratories and patient service centers, and
provides interpretive consultation through its extensive medical and
scientific staff. Quest Diagnostics is the leading provider of esoteric
testing, including gene-based medical testing, and also empowers healthcare
organizations and clinicians with state-of-the-art connectivity solutions that
improve patient care. Additional company information is available at:
www.questdiagnostics.com.
The statements in this press release which are not historical facts or
information may be forward-looking statements. These forward-looking
statements involve risks and uncertainties that could cause actual results and
outcomes to be materially different. Certain of these risks and uncertainties
may include, but are not limited to, unanticipated expenditures, changing
relationships with customers, payers, suppliers and strategic partners,
competitive environment, changes in government regulations, conditions of the
economy and other factors described in the Quest Diagnostics Incorporated 2002
Form 10-K and subsequent filings.
(1) The sensitivity of InSure Fecal Occult Blood Test was assessed in a
study of a high-risk population.
(2) CA Cancer J Clin 2003; 53:44-55.
(3) National Health Interview Survey, 2000, National Center for Health
Statistics, Centers for Disease Control and Prevention, 2002 -
American Cancer Society, Surveillance Research.
(4) Data from the Centers for Disease Control's (CDC) Behavioral Risk
Factor Surveillance System (BRFSS) for 2000 and 2001.
SOURCE Quest Diagnostics Incorporated
-0- 08/07/2003
/CONTACT: Laure Park (Investors), +1-201-393-5030, or Jennifer Somers
(Media), +1-201-393-5700, for Quest Diagnostics/
/Web site: http://www.questdiagnostics.com/
(DGX)
CO: Quest Diagnostics Incorporated; Enterix Inc.
ST: New Jersey
IN: MTC HEA
SU: PDT