What is the Second Generation FIT® test?

The Fecal Immunochemical Test, or FIT, detects elevated globin (the most predictive biomarker of colon and rectal cancer) in the lower GI tract.  This biomarker can be indicative of many things, such as colon or rectal cancer, diverticulitis, colitis, Chron’s disease, IBD, and IBS just to name a few.  A positive fecal immunochemical test should always be reported to your primary care physician or gastroenterologist.

The Fecal Immunochemical Test (FIT) tests human hemoglobin in the stool, which can be an early sign of cancer. FIT only detects human blood from the lower intestines. Medicines and food don't interfere with the test, so it tends to be more accurate and have fewer false positives than other tests.  The Second Generation FIT® specifically targets globin levels in access of 50 ng/mL in the stool sample. Elevated goblin, a component of hemoglobin, the oxygen transport mechanism of blood, has been identified as the preeminent biomarker for colorectal cancer.

The fecal immunochemical test has been around since 2000 in developmental phases.  Once it could be proven that the FIT test could reduce mortality and morbidity, with increased accuracy vs. the guaiac test, it was FDA approved.  With the FIT test's FDA approval, came a CLIA (Clinical Laboratory Improvement Amendment Act of 1988) waiver. This meant the FIT test could be performed in doctor's offices, not just hospital labs.   Pinnacle BioLab's Second Generation FIT® obtained an even higher stature from the FDA - "Over the Counter" clearance.  This simply means that in addition to the rigors of FDA clearance and CLIA waived testing, the test can also be performed by the layperson (that's you) with little to no chance that you would interpret the test incorrectly.  Essentially, Pinnacle has cut out the ambiguity of reading the results, and provided studies showing it can be done by anyone.  Hence, "Second Generation".

Second Generation FIT® is FDA over the counter cleared to aid in the detection of colon and rectal cancer, diverticulitis, colitis, Crohn's Disease, Irritable Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS).

This answer varies depending on who you ask.  Some things are for certain:  If you are 50 or older, you should be screening for colon cancer.  If you are African American, you should begin at 45.  If you have a first degree relative (mom or dad, brother or sister) you should begin screening 10 years prior to when they were diagnosed.  

Food for thought:  The guideline to begin screening at 50 is arbitrary.  What does that mean? It means actuaries at insurance companies came up with this number a long time ago.  Keep in mind, there was no $25 test to screen for colon cancer at that time, just a colonoscopy.  Recently, the national news media has reported millennials being diagnosed with colorectal cancer at unprecedented rates.  Healthcare is becoming more personal than ever.  With Second Generation FIT®, the decision of when to begin screening is yours.

How does it work?

The science behind the most advanced biomarker for colorectal cancer is exacting.  A Second Generation FIT Fecal Immunochemical Test will generate a positive result at equal to or greater than 50 nanograms of spiked globin levels in feces.  A nanogram is 1 billionth of a gram.  The Second Generation FIT® is counting billionths of the colorectal cancer biomarker.  To visualize a nanogram consider a paperclip, which weighs approximately 1 gram. Now imagine dividing it into one million pieces. Now divide just one of those pieces into 1,000 pieces. That would be a nanogram.

The manufacturing of the FIT is precise.   Pinnacle BioLabs FIT tests are designed in Nashville, TN and made entirely in the USA.  While assembly lines and high tech equipment are necessary for design, the actual tests themselves are all hand made.  The colloid-gold double sandwich dye conjugate assays underneath the plastic cassettes are cut and placed, by hand, ensuring the glass fibers match up to the wells exactly for optimal performance, all of which is done in a state-of-the-art facility.  Simply put:  beautiful, thick, clear, rose-colored bands set Second Generation FIT® apart from other tests.  

Taking the test

Yes, nearly all of them.  Annual FIT is recommended by the American Cancer Society for screening programs for the early detection of adenomatous polyps, precursors to cancer, and colorectal cancer, in individuals of average risk starting at age 50 years. FIT, along with colonoscopy, is also recommended as ‘Tier 1’ preferred tests for colorectal cancer screening programs by the U.S. Multi-Society Task Force.

 The American College of Gastroenterology recommends a FIT test ANNUALLY for persons over 50 with African Americans beginning an annual test at 45.  For persons unwilling or unable to have a colonoscopy, the FIT test has been shown to be nearly as effective as colonoscopy for detecting colorectal cancer.  Please note that while a FIT test may detect colon cancer or other disease states mentioned above, ONLY a colonoscopy can confirm these disease states.

You do not need to do anything to prepare for the test.  Continue all prescribed medications (because hey, they're prescribed for a reason) and your normal diet routine can stay the same too.

Some people may be squeamish about collecting the sample. But you won't feel anything during the test, as it is an in vitro diagnostic.  "In vitro" means "outside the body".  It's as simple as getting a small sample of fecal matter off of toilet paper.

Colon cancer is the second leading cause of death among all cancers in the United States.  Preventative medicine, such as the Second Generation FIT® test, can actually prevent cancer in some cases.  FIT tests have also shown to catch cancers relatively early (Stage 1, Stage 2) where the five year survivability outcomes are above 95%.  Blood in the stool is a possible early sign of colon cancer. This test is performed to detect blood in the stool that you can't see. This type of screening can detect problems that can be treated before cancer develops or spreads.

Still have questions?  Talk with your doctor about when you should have colon screenings.  

Reading the results

Included with every Second Generation FIT® test kit is a package insert.  This is the two-sided document with pictures on one side.  The quick reference guide (picture side) tells most people all they need to know to perform and result the test.  Lost yours?  Download it here.  

A negative result, or one line at the control (C) region, is the optimal outcome for the Second Generation FIT® test.  You are considered screening for colon cancer and your next step is to re-screen in a year.  Pinnacle BioLabs will even send you a reminder and 10% off twelve months after you order.

 Keep in mind, there are rare instances of false negative results, so stay "in tune" with your body and notify your physician of changes you deem concerning.   

Don't panic.  You're ahead of the game.  Remember, the Second Generation FIT® test is FDA cleared to aid in the detection of Colorectal Cancer, Diverticulitis, Colitis, and Crohn's Disease.  One thing is for sure:  Studies have shown that "Time to Colonoscopy" is the number one variable in obtaining better outcomes with respect to disease treatment and prevention.  Schedule a colonoscopy.  Also let your gastroenterologist know that you've taken a FIT test and the results came back positive.  Ideally, your colonoscopy should be within six months of the positive Fecal Immunochemical Test.  

This is the most common phone call we receive.  You perform the test with no issues, get your results and discard your test.  30 or 40 minutes later you look in the waste basket and the Second Generation FIT® test now reads positive!  This is absolutely normal.  In fact, no results should be interpreted after ten minutes for this reason.