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Enterix releases new point-of-care test for colorectal cancer screening

Quest Diagnostics : 09 May, 2008  (New Product)
Enterix , a wholly-owned subsidiary of Quest Diagnostics , has introduced the InSure Quik F I T faecal 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 USA (Ref 1), screening rates for the disease are low compared to screenings for cervical and prostate cancers (Ref2, 3), and colorectal cancer claims the lives of up to 50,000 Americans each year (Ref 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 percent greater sensitivity for colorectal cancer than a leading guaiac-based FOBT screening test (Ref 4).

The InSure Quik FIT 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 FIT, alongside our national challenge called 'Do You Have The Guts,' can help to do just that,' said Stephen C Suffin, MD, corporate clinical pathologist and interim chief laboratory officer, Quest Diagnostics. 'The availability of InSure Quik FIT 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 FIT 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 programmes. 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 percent more compliant in completing their InSure test compared to a leading guaiac-based FOBT test (Ref 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.

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 and HemoCue, 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.

Ref 1 - American Cancer Society - Cancer Facts and Figures 2008.

Ref 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.

Ref 3 - Ferrini R et al. Screening for prostate cancer in American men. American College of Preventive Medicine Practice Policy Statement.

Ref 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.

Ref 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.
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