The InSure Test Should Help Reduce Colorectal Cancer Mortality and Incidence
LYNDHURST, N.J., Nov. 2 /PRNewswire-FirstCall/ -- A study published in the
journal CANCER found that InSure,(R) a Fecal Immunochemical Test (FIT) from
Quest Diagnostics Incorporated (NYSE: DGX) detected three times as many early-
stage colorectal cancers and nearly two times as many significant (pre-
cancerous) adenomas compared to Hemoccult II Sensa(R)(1), the traditional
guaiac fecal occult blood test.(2)
In the study published in CANCER, individuals sampled consecutive stools,
at home, to complete both the InSure and the Hemoccult II Sensa tests. Study
groups included a screening cohort (n=2,351) and a symptomatic diagnostic
cohort (n=161). Patients with positive screening results were referred for
colonoscopy to detect possible cancer or a significant adenoma. Following
colonoscopy, the cancer and type of polyp were subsequently confirmed by
histopathology. The InSure FIT demonstrated a true-positive result
significantly more often in the presence of cancer (n=24, 87.5% vs. 54.2%) or
significant adenoma (n=61, 42.6% vs. 23.0%) than did Hemoccult II Sensa. Of
all stage I cancers (where the tumor is limited to the lining of the bowel
wall), the InSure FIT was positive in 12 of 13 cases, compared to only 4 of 13
with the Hemoccult II Sensa (p=0.002). The study results also showed that the
InSure test is more capable than the Hemoccult II Sensa in detecting lower
gastrointestinal bleeding in early-stage lesions or significant adenomas.
The InSure test had a marginally higher false-positive rate than did
Hemoccult II Sensa (3.4% vs. 2.5%, respectively). This difference was due to
detection of non-neoplastic pathologies, which when excluded the difference in
false-positive rates became statistically insignificant (1.2% vs. 1.3%,
respectively for the InSure and Hemoccult II Sensa tests).
"Early detection of significant adenomas and their removal should lead to
a decrease in the number of people who will develop colorectal cancer," said
Graeme P. Young, MD, FRACP, Professor of Gastroenterology, Department of
Medicine, Flinders University of South Australia, where the study was
conducted. "Importantly, this technology also has distinct behavioral
advantages-people are more likely to complete and return the test owing to its
simpler sampling procedure and reduced number of samplings."
Colorectal cancer is the second leading cause of cancer death in the
United States. According to American Cancer Society (ACS) estimates, of the
approximately 55,000 people expected to die from colorectal cancer this year,
appropriate screening could save more than half. Patients with colorectal
cancer detected in its earliest stage have a 90 percent chance of 5-year
survival. ACS's latest guidelines for annual colorectal cancer screening
include an option for an annual fecal immunochemical test or fecal occult
blood test for people at average risk, 50 years of age and older.
"This is an important finding in the battle against colorectal cancer
where early detection is critical," said Joyce G. Schwartz, MD, Vice President
and Chief Laboratory Officer, Quest Diagnostics. "Since we began offering the
InSure test, we've seen more doctors recommending it to patients, most likely
because of the test's patient-friendly sample collection features."
About InSure
InSure FIT is a test that uses anti-human hemoglobin antibodies that are
highly specific to human globin, the primary protein in blood that is released
in stool when cancer and significant pre-cancerous adenomas are present in the
colon and rectum. In contrast, guaiac-based fecal occult blood tests detect
peroxidase activity of heme -- the part of hemoglobin that contains iron -- in
feces; dietary peroxidases and heme from red meat may cause false positives.
Quest Diagnostics is the only laboratory to offer the InSure Fecal
Immunochemical Test, an FDA-cleared test for use in screening for sources of
lower gastrointestinal bleeding. The InSure test has features that increase
the likelihood people will use the tests and return specimens. Among those
features:
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No unpleasant fecal collection and smearing is required. The InSure
test utilizes a patented long-handled brush to gently brush the
surface of the stool and collect the surrounding toilet water to dab
onto the collection card. Whereas, the standard guaiac-based fecal
occult blood test requires a wooden spatula collection of the stool
sample that is completely clear of toilet water to be smeared on a
test card.
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Only two specimens are required from consecutive bowel movements,
compared to traditional Hemoccult II Sensa, which require six
specimens from three bowel movements for analysis.
The study published in CANCER was funded by grants from the National
Health and Medical Research Council of Australia and Enterix Australia Pty.
Ltd. Enterix was acquired by Quest Diagnostics in September 2006. Neither
company participated in the study's data analysis or influenced conclusions
reached.
For more information on the study published in CANCER:
http://www3.interscience.wiley.com/cgi-bin/fulltext/113348447/PDFSTART
For more information on colorectal cancer:
American Cancer Society
http://www.cancer.org/docroot/CRI/content/CRI_2_6X_Colorectal_Cancer_Early_Det
ection_10.asp
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: http://www.questdiagnostics.com.
The statements in this press release that 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, competitive environment, changes in
government regulations, changing relationships with customers, payers,
suppliers and strategic partners and other factors described in the Quest
Diagnostics Incorporated 2005 Form 10-K and subsequent SEC filings.
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Hemoccult II Sensa is a trademark of Beckman Coulter, Inc.
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Smith, A., Young, G. et al. Comparison of a brush-sampling fecal
immunochemical test for hemoglobin with a sensitive guaiac-based fecal
occult blood test in detection of colorectal neoplasia. Cancer 2006;
107 (9) 2152-59.
SOURCE Quest Diagnostics Incorporated
CONTACT: Jennifer Somers, Media, +1-201-393-5700, or Laure Park,
Investors, +1-201-393-5030, both of Quest Diagnostics
Web site: http://www.questdiagnostics.com