InSure® FIT™ Colorectal Screening Test

About Colon Cancer | About the Test | Using the Test | FAQ

One of the Most Common Cancers is Now Simple to Test For

Sampling In the Privacy of Your Own Home! "Lab Results in 1-2 Weeks"

You May Be At Risk If You...

Are Over 50 Years of Age & Don't Get Tested
Had Colon Cancer or Polyps or Cancer in the Past
Have Ulcerative Colitis of Crohn's Disease
Use Inferior Testing Methods
Eat a Diet High in Fat & Low in Calcium, Fiber, & Folate
Have a Family History of Colorectal Cancer
Smoke Cigarettes or Drink Alcohol

Synergy Labs can make colorectal cancer screening easier.

A Simple and Convenient Collection Kit with NO Fecal Handling in the Privacy of Your Own Home

Receive InSure FIT test in your mailbox.
Use one of the provided waste bags for the used toilet tissue.
Gently brush the surface of the stool from the first bowel movement for about 5 seconds.
Apply TOILET WATER SAMPLE from first stool to test card.
Repeat steps for second bowel movement.
Mail completed test card. Results in
1-2 weeks.

Each year, about 150,000 Americans are diagnosed with colorectal cancer, and about 50,00 die from the disease.

family However, fewer than half of people found to have colorectal cancer are diagnosed at an early stage when treatment is most effective. This means that many people are living with a serious risk that they don't even know about. Don't brush off your risk of getting colorectal cancer.

Colorectal cancer does not discriminate! You Owe it to yourself
and you owe it to your family to get tested once a year.

Clinical Studies
Studies have shown that the InSure® FIT™ test is highly sensitive for detecting blood in and around the stool, a key indicator of abnormalities in the colon and rectum that doctors use to help diagnose colorectal cancer.

Highly Accurate
Helps ﬁnd colorectal cancer at treatable, early stages in the privacy of your own home.

Easier to Use
The only screening test with the long-handled blue brush that eliminates the unpleasant fecal collection and smearing associated with traditional at-home collection methods.

There are no medicinal or dietary restrictions before or during taking the test.

Product Comparison

InSure Comparison Chart

About Colon Cancer

Colon Cancer: America’s Third Most Common Type of Cancer

Colorectal cancer is the third most common type of cancer among men and women in the United States.¹ The American Cancer Society estimates that about 108,070 new cases of colon cancer (53,760 in men and 54,310 in women) and 40,740 new cases of rectal cancer (23,490 in men and 17,250 in women) will be diagnosed in 2008.
In the United States, a man's average lifetime risk of colon cancer is about one in 17. For a woman, the risk is about one in 19.²
Medical experts advise that anyone at age 50 or older at average risk should, as one of their screening options, be screened annually with the fecal occult blood test (FOBT) or the newer fecal immunochemical (FIT) for this disease. Talk to your doctor about screening earlier if you believe you are at higher than average risk for colorectal cancer.³

Colorectal Cancer Screening is Important.
Are You a Doubter or a Doer? These Facts Will Turn You Around.

Colorectal cancer screening works! The number of deaths from colorectal cancer has been declining for the past 15 years, likely due in part to increased screening, which allows for earlier detection of cancer and precancerous polyps and earlier treatment. Because of this, there are now about 1 million colorectal cancer survivors in the United States.⁴
If caught earlier (in the localized stage), the relative five-year survival rate for colorectal cancer is higher than 90%, compared with only about 10% in people with advanced disease.

Screening is the most important tool for catching colorectal cancer early.²

Your risk of getting colorectal cancer increases with age. Men and women with a personal or family history of colorectal cancer and/or polyps or a history of inflammatory bowel disease may be at higher risk. Obesity, physical inactivity, heavy alcohol consumption, smoking, and diets high in red or processed meat may also increase the risk of developing colorectal cancer.⁴

Medical experts recommend, as one of the screening options, annual colorectal cancer screening using FOBT or FIT tests.^1,2 There are numerous screening options, including but not limited to:

A fecal immunochemical test (FIT) or fecal occult blood test (FOBT) every year; or
Flexible sigmoidoscopy every 5 years; or
An FIT or FOBT every year plus flexible sigmoidoscopy every 5 years (of these first 3 options, the combination of FIT or FOBT every year plus flexible sigmoidoscopy every 5 years is preferable.); or
Double-contrast barium enema every 5 years; or
Colonoscopy every 10 years.

In a U.S. clinical study, colorectal cancer deaths were reduced by 33% when annual fecal occult blood tests were performed.⁵

Underuse of Screening

Colorectal cancer screening remains underused, despite the availability of effective screening tests.⁶

Screening for colorectal cancer lags far behind screening for breast and cervical cancers.
As many as 60% of deaths from colorectal cancer could be prevented if everyone age 50 and older were screened regularly.
In one study, the InSure® FIT™ test with the more convenient Blue Brush Method had as much as 66% better compliance compared to a leading guaiac-based FOBT screening test.⁷

References:

Centers for Disease Control and Prevention. Colorectal Cancer: Basic Information:
Mayo Foundation for Medical Education and Research (MFMER)
U.S. Preventive Services Task Force. Screening for Colorectal Cancer: Recommendations and Rationale. July 2002. Agency for Healthcare Research and Quality, Rockville, MD.
American Cancer Society. Colorectal Cancer: Early Detection. Accessed February 4, 2008.
Mandel, J.S., et al.: “Reducing mortality from colorectal cancer by screening for fecal occult blood”. N.Eng.J.Med 328:1365-1371, 1993
Centers for Disease Control and Prevention. Colorectal Cancer: Screening Rates.
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.

About The Test

The InSure® FIT™ test and its unique Blue Brush Method make it easier to screen for colorectal cancer.

Clinical studies have shown that the InSure® FIT™ test is highly sensitive for detecting blood in and around the stool, a key indicator of abnormalities in the colon and rectum that doctors use to help screen for colorectal cancer.

The InSure® FIT™ test has an 87% sensitivity for colorectal cancer.^1,2 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.²

An FOBT done during a digital rectal exam (DRE) in the doctor’s office is not sufficient for screening and is not recommended by American Cancer Society guidelines. If your doctor performs a DRE, you should ask him or her about the InSure® FIT™ test.
The guaiac-based FOBT tests have a risk of false positive results related to both red meat consumption and the use of certain medications around the time of sample collection, and therefore have drug and dietary restrictions. The InSure® FIT™ test has no drug or dietary restrictions.¹

InSure® FIT™ Test Makes Annual Screening Easier

The InSure® FIT™ test kit provides a more convenient sample collection method, making annual colorectal cancer screening easier to fit into your life. Doctors often say that the best test is the one that is completed.

The InSure® FIT™ test is easier to use. To get a reliable sample, patients only need to gently brush the surface of the stool in water for about 5 seconds with the convenient, long-handled blue brush.
In one study, the InSure® FIT™ test had as much as 66% better compliance compared to a leading guaiac-based FOBT.²

Here’s why:

No other take-home colorectal cancer screening test has this convenient, water-based collection method – if you have used a paintbrush, you can use the InSure® FIT™ test.
The InSure® FIT™ test can be used after meals and while taking any medications. There are no special food or medication restrictions.
With the InSure® FIT™ test, samples are collected in the privacy of your home, then submitted to your doctor’s office for analysis.

The InSure® FIT™ test is available from your doctor. The Patient Collection Kit contains everything you need to collect and submit test samples for analysis.

InSure® FIT™ product inserts
Smith A, Young GP, Cole SR, 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. The study was funded in part by Enterix Inc. (through Enterix Australia Pty. Ltd), the manufacturer of InSure FIT. Enterix is now owned by Quest Diagnostics Incorporated. However, neither Enterix nor Quest Diagnostics participated in the data analysis or influence the conclusions reached by the authors. One of the authors, GP Young, is a consultant for Enterix Australia Pty. Ltd.
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.

Using the InSure® FIT™ Patient Collection Kit
and Test Card

How it Works

The InSure® FIT™ Test method is based on the detection of human hemoglobin (Hb). Human Hemoglobin indicates the presence of blood in the stool. The test detects the globin (protein) portion of the Hb molecule. Because globin does not survive passage through the upper gastrointestinal (g.i.) tract, any globin in the stool indicates that there is bleeding in the lower colon or rectum, the region where colorectal cancers originate.

Easy Sample Collection

Your healthcare professional will give you an InSure® FIT™ Patient Collection Kit to take home with you.
Take these instructions, Brush Kit and Test Card into the bathroom.
Flush the toilet BEFORE your bowel movement.
After your bowel movement, DO NOT PLACE USED TOILET PAPER IN THE TOILET BOWL. Instead, use one of the waste bags provided. DO NOT FLUSH the toilet.
Lift the flap marked "A" or "LIFT HERE FOR SAMPLE 1" on the Test Card to uncover the small white square underneath.
USING ONE OF THE BLUE BRUSHES, GENTLY BRUSH THE SURFACE OF THE STOOL FOR ABOUT 5 SECONDS.
If the stool is loose, simply stir the water around the stool.
Remove the brush from the water and gently shake it once to remove excess water and any clumps of stool.
Transfer the WATER sample by gently dabbing the bristles of the brush onto the small white square on the Test Card for about 5 seconds (some staining of the square may occur).
Put the used brush into the kit waste bag and throw away in your rubbish bin.
For the first sample, PRINT YOUR NAME, DATE OF BIRTH, AND THE DATE THE SAMPLE WAS COLLECTED on one of the labels located on these instructions for use.
Peel off the label and use it to reseal the flap marked "A" or "SAMPLE 1". See diagrams above for the correct positioning of label.
Using the second blue brush, waste bag and the Test Card flap marked "B" or "LIFT HERE FOR SAMPLE 2", repeat steps 1- 6 shown above. Use the other label to reseal the B flap or SAMPLE 2.
Place the Test Card in the envelope.
Return to the indicated laboratory or medical professional office either by post or personal delivery.

PDF Instructions for Use

Warnings & Precautions

Some conditions may cause a wrong result - you should not perform this test if:

You have hemorrhoids that are bleeding.
You have blood in your urine, or if you see blood in the toilet bowl. In this case, contact your doctor.
It is during or within 3 days of your menstrual period.
You have any bleeding cuts or wounds on your hands.
The test card has passed its expiration date.
The test kit is damaged, dirty, or appears to have been tampered with in any way.
If your toilet water is saltwater or rusty.

Limitations of the Test

Because colorectal conditions may not bleed all the time, also blood may not be uniformly distributed in the stool, the test result may be negative even when blood or lower gastrointestinal disease is present. As with any fecal occult blood test, results obtained with the InSure® FIT™ test should not be considered conclusive evidence of the presence or absence of bleeding or disease. Your physician will make a diagnosis based on further testing and evaluation.

FAQ

I know the screening test is important. Why should I take this test? And… why now?

American Cancer Society guidelines recommend yearly FIT or FOBT tests for people at least 50 years of age at average risk, as one of the recommended screening options.1,2

Colorectal cancer is the second leading cause of cancer death in the U.S., yet one of the few cancers that is largely curable if detected in the early stages and can even be prevented in some cases by removing polyps.
When colorectal cancers are detected at an early stage, the five-year survival is 90%; however, only 39% of colorectal cancers are diagnosed at this stage.

According to the United States Centers for Disease Control and Prevention (CDC), up to 60% of deaths from colorectal cancer could be avoided if people over 50 received the recommended screening tests.3
An FOBT done during a digital rectal exam in the doctor's office is not sufficient for screening and is not recommended by American Cancer Society guidelines. If your doctor performs a DRE, you should ask him or her about the InSure® FIT™ test.

Are FITs (fecal immunochemical tests) effective for detecting colorectal cancer?

The InSure® FIT™ test has demonstrated an 87% sensitivity for colorectal cancer.5,6 FIT tests are one of the screening options recommended by the guidelines from the American Cancer Society.

What do specificity and sensitivity mean?

Sensitivity is a measure of the ability of a test to find the disease when it is present. A highly specific test is one that rarely indicates abnormality when no abnormality is present.

Where can I get an InSure® FIT™ screening test?

You can get the InSure® FIT™ test for colorectal cancer from your Doctor.

Are the InSure® FIT™ tests covered by my insurance?

Colorectal cancer screening tests are covered by most insurance plans. For more information, review your health insurance policy or discuss with your health insurance provider.

Will I need to follow a special diet in order to use the InSure® FIT™ test?

No. You do not need to change your diet in any way before using the InSure® FIT™ test. Unlike traditional guaiac-based FOBTs, you don't need to avoid any foods before using this test.

Will I need to follow a special medication routine, or change my current medications, in order to use the InSure® FIT™ screening test?

No. Unlike the traditional guaiac-based take-home FOBTs, you do not need to change any medications or medication routines.

Will I have to handle my stool when using the InSure® FIT™ screening test?

No! The InSure® FIT™ test with the patented long-handled blue brush, allow you to perform the screening test with no fecal handling or smearing. After each of two different bowel movements, use the patented long handled blue brush to gently brush the surface of the stool in water for about 5 seconds, and then dab it onto the test card. We call this the Blue Brush Method!

Why will I need to provide two samples?

Because colorectal conditions may not bleed all the time, or blood may not be uniformly distributed in the stool, multiple sample FOBT or FIT take-home tests are recommended by the American Cancer Society (ACS) as one of the screening options. A single FOBT done during a digital rectal exam in the doctor's office is not sufficient for screening and is not recommended by the ACS. The InSure® FIT™ test requires one sample from two different bowel movements.

How is the InSure® FIT™ screening test different from traditional guaiac-based fecal occult blood tests (FOBTs)?

With the InSure® FIT™ test, the sampling procedure is more user-friendly. Unlike traditional guaiac-based FOBTs and some other FIT tests, the patented InSure® FIT™ brush requires no fecal handling, and requires only two samples. Because InSure® FIT™ test detect human hemoglobin from blood, there are no drug or dietary restrictions required to complete the test.

How is the InSure® FIT™ test different from a stool DNA (sDNA) test?

Unlike the InSure® FIT™ test, stool DNA tests require patients to pack an entire bowel movement in a kit and send the sample to a laboratory for testing. InSure® FIT™ tests are more convenient and easier-to-use than sDNA tests because of their unique Blue Brush Method for sample collection. After each of two different bowel movements, the patient uses the patented long-handled blue brush to gently brush the surface of the stool in water for about 5 seconds, and then dab it onto the test card.

Should I use the InSure® FIT™ test if I see blood in the toilet bowl?

No. You should not use InSure® FIT™ test if you see blood in the toilet bowl. If you see blood in the toilet bowl, you should immediately consult your physician.

Should I use the InSure® FIT™ screening test if I have hemorrhoids that are bleeding?

No. You should not use the InSure® FIT™ test if you have any hemorrhoids that are actively bleeding. Because the InSure® FIT™ screening test detects blood in and around the stool, active bleeding from hemorrhoids could provide a false positive test result.

Can I do the test if I am menstruating?

No. You should not perform the test three days before, during, or three days after your menstrual period. Because the InSure® FIT™ screening test detects blood in and around the stool, active bleeding from menstruation could provide a false positive test result.

Can I do the test if someone in my house is menstruating?

You can perform the test if someone else in the house is menstruating, provided that you flush the toilet before beginning your sample collection process.

Does a positive result mean I have cancer?

Not necessarily. A positive test only indicates that blood was detected in the samples collected. This blood may be from conditions other than colorectal cancer. If you have a positive result, we strongly urge you to discuss the findings with your physician to establish the source of the bleeding and determine treatment, if appropriate. In general, a further test of the colon and rectum (such as a colonoscopy) may be required.

American Cancer Society. Colorectal Cancer Screening Guidelines. Accessed February 4, 2008.
U.S. Preventive Services Task Force. Screening for Colorectal Cancer: Recommendations and Rationale. July 2002. Agency for Healthcare Research and Quality, Rockville, MD.
Centers for Disease Control and Prevention. Colorectal Cancer: Screening Rates. http://www.cdc.gov/cancer/colorectal/statistics/screening_rates.htm
American Cancer Society. Detailed Guide: Colon and Rectum Cancer - What Are the Risk Factors for Colorectal Cancer?
InSure® FIT™ product inserts
Smith A, Young GP, Cole SR, 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. The study was funded in part by Enterix Inc. (through Enterix Australia Pty. Ltd), the manufacturer of InSure® FIT™ . Enterix is now owned by Quest Diagnostics Incorporated. However, neither Enterix nor Quest Diagnostics participated in the data analysis or influence the conclusions reached by the authors. One of the authors, GP Young, is a consultant for Enterix Australia Pty. Ltd.