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 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.
Clinical studies have shown that the Fecal Immunochemical Test t is highly sensitive for detecting human hemoglobin in and around the stool, a key indicator of abnormalities in the colon and rectum that doctors use to help screen for colorectal cancer. In a study of patients who were at average risk, high risk or had no symptoms at all, FIT was found to have 33% greater sensitivity for colorectal cancer than a leading guaiac-based FOBT screening test.
The science behind the most advanced biomarker for colorectal cancer is exacting. The 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 Fecal Immunochemical Test 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 Pinnacle’s FIT product apart from other tests.
Ease of use is the main concern behind every step of the design and manufacturing process. Often times physicians and nurses will perform rapid, in-vitro diagnostic tests and find themselves wondering “Is this a positive result or not?” Our Fecal Immunochemical Test simply doesn’t have that issue, as it is as decisive as it is accurate. So much so the FDA granted our FIT product OTC (over-the-counter) status, meaning that not only would medical professionals have no problem performing the test - but it was so intuitive and easy to read non-medical people would have no problem performing it.
The FIT test saves lives. Our packaging saves trees. In early 2014 we began working with Amazon.com on a new concept called “Frustration Free Packaging" which is been an overwhelming success. We save an estimated 1.5 trees per day in packaging, and at a reduced shipping cost (and its toll on the environment) of nearly 60%.