Enterix Inc. Launches Its Point-of-Care Test for Colorectal Cancer Screening
- New test provides laboratory-quality results in physician's office -
May 8, 2008
Enterix Inc., a wholly-owned subsidiary of Quest Diagnostics Incorporated , today announced the availability of the InSure® Quik F I T™ fecal immunochemical test, a point-of-care version of the company's lab-based InSure® FIT™ test, that provides physicians with the sensitivity and specificity of the laboratory-based InSure FIT test.
The availability of the CLIA-waived InSure Quik F I T test is intended to help physicians increase patient compliance with an annual colorectal cancer screening test. Although colorectal cancer is the second leading cause of cancer in the U.S.(1), screening rates for the disease are low compared to screenings for cervical and prostate cancers(2),(3), and colorectal cancer claims the lives of up to 50,000 Americans each year.(1) The American Cancer Society (ACS) recommends yearly screening with a fecal occult blood test (FOBT), such as the fecal immunochemical test (FIT) as an alternative to colonoscopy every ten years, for people 50 and older at average risk, to improve rates of early detection of this disease, which is largely treatable if detected in its early stages.
Studies have shown that the InSure FIT test is highly sensitive for detecting blood in or around the stool. In a study of patients who were at average risk, high risk or had no symptoms at all, InSure FIT was found to have 33% greater sensitivity for colorectal cancer than a leading guaiac-based FOBT screening test.(4) The InSure Quik F I T test uses the same patient-friendly blue brush collection method as the InSure FIT and is considered substantially equivalent to the InSure FIT test.
"Quest Diagnostics is committed to helping increase the number of people getting screened annually for colorectal cancer -- and the launch of InSure Quik F I T, alongside our national challenge called 'Do You Have The Guts,' can help to do just that," said Stephen C. Suffin, M.D., corporate clinical pathologist and interim chief laboratory officer, Quest Diagnostics. "The availability of InSure Quik F I T reinforces two of our company's priorities - - providing physicians and patients with diagnostic insights that can help improve preventive care, and improving and simplifying patient care with a growing portfolio of point-of-care testing options. Colorectal cancer is often treatable and even preventable when caught early, which is why annual screening with the InSure Quik F I T test is so important."
FIT tests detect blood in the stool that might indicate colorectal cancer or other lower gastrointestinal diseases. FIT tests help identify individuals that are candidates for colonoscopy, even if they do not have overt symptoms of colorectal cancer. This may mean the disease is in its early, more treatable stages, or that they may have precancerous polyps that can be removed during colonoscopy.
In addition to sensitivity and specificity, the unique features of the InSure family of tests have been shown to increase patient compliance with annual colorectal cancer screening programs. InSure FIT and InSure Quik F I T feature a unique long-handled blue brush to collect two water-based samples -- rather than the solid samples required by other FIT or FOBT tests. In addition, InSure Quik F I T does not require any change in patient diet or medication, enhancing its ease of use. In one study, patients were 66% more compliant in completing their InSure test compared to a leading guaiac-based FOBT test.(5)
To further encourage patient participation in yearly colorectal cancer screening, Quest Diagnostics recently launched an innovative, online educational campaign entitled: "It's Time To Challenge Colon Cancer: Do You Have The Guts?" The campaign aims to increase compliance with annual FOBT screening by breaking down barriers to patient action. The campaign has announced a goal of reaching five million people over 50 in five years. To learn more about the Challenge and the InSure family of tests, visit www.doyouhavetheguts.com.
Both InSure Quik F I T and InSure FIT are manufactured by Enterix Inc. Physicians can purchase the new InSure Quik F I T point-of-care test from Enterix Inc. and HemoCue, Inc., which distributes the test. The laboratory services for the InSure FIT test are provided by Quest Diagnostics, and collection kits for the InSure FIT test can be obtained from Quest Diagnostics. Both HemoCue and Enterix are companies owned by Quest Diagnostics. For more information, call 800-531-3681.
About Colorectal Cancer
Colorectal cancer, which refers to cancer of the colon and rectum, is expected to have caused approximately 52,000 deaths in the U.S. in 2007. Patients with colorectal cancer detected in its earliest stage have a 90 percent chance of five-year survival. Although guidelines from the American Cancer Society (ACS) recommend that all men and women of average risk should begin regular screening at 50 years of age or older, a recent study found that only about one in four patients receiving Medicare received guideline-based follow-up screening between 1998 and 2004. Screening methods include colonoscopy, once every ten years, as well as flexible sigmoidoscopy, double-contrast barium enema and FOBTs.
About Enterix Inc.
Enterix Inc., a Quest Diagnostics Company, is a U.S.-based biotechnology company founded in 1997. Enterix manufactures, markets, and distributes a leading-edge product for colorectal cancer screening called InSure®, a fecal immunochemical test (FIT) that is a useful screening aid for detecting primarily lower gastrointestinal bleeding disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other gastrointestinal lesions that can bleed. Health professionals recommend FIT tests for use in screening for colorectal cancer or other sources of lower gastrointestinal bleeding. Enterix Inc. was acquired in August 2006, by Quest Diagnostics, and is a wholly owned subsidiary of Quest Diagnostics Incorporated. Additional information is available at: www.insuretest.com.
The HemoCue family of companies, acquired by Quest Diagnostics in 2007, is a global leader in a field of diagnostics known as near patient, or point-of-care, testing. In 1982, HemoCue AB, based in Angelholm, Sweden, introduced the first system making accurate hemoglobin testing possible in near-patient settings. Since then, more than 250,000 HemoCue systems have been sold worldwide. The company also manufactures point-of-care tests for glucose, urine albumin, and total white blood cell count. HemoCue subsidiaries, affiliates, franchises, and third-party distributors generate revenue in more than 100 countries, including England, Finland, Germany, the Netherlands, Switzerland, Norway, Denmark, Sweden and the U.S. HemoCue, Inc., is a U.S. distributor of products made by HemoCue AB and of the InSure Quik F I T point-of-care fecal immunochemical test. Additional company information is available at www.hemocue.com.
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 information is available at: 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 2007 Form 10-K and subsequent SEC filings.
(1) American Cancer Society - Cancer Facts & Figures 2008. (2) Solomon D et al. Cervical Cancer Screening Rates in the United States and Potential Impact of Implementation of Screening Guidelines. CA Cancer J Clin 2007; 57; 105-111. (3) Ferrini R et al. Screening for prostate cancer in American men. American College of Preventive Medicine Practice Policy Statement. (4) Smith A, 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; 107:2152-2159. (5) Cole SR, Young GP, Esterman A, Cadd A, Morcom J. A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. J Med Screen 2003;10:117-122.
SOURCE: Quest Diagnostics
CONTACT: Investors: Laure Park, +1-973-520-2900, or Media: Barb Short,
+1-973-520-2800, both for Quest Diagnostics