The Second Generation FIT, or Fecal Immunochemical Test, detects blood in the lower GI tract. Blood in the lower GI tract 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 FIT test should always be reported to your primary care physician or gastroenterologist.
Clinical studies have shown that the Pinnacle BioLabs Second Generation FIT Colorectal Cancer Detection Test 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, The Pinnacle BioLabs Second Generation 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 Second Generation FIT will generate a positive result at equal to or greater than 50 nano grams 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 Second Generation FIT is exacting. Designed in Nashville, TN, with specific parts from The Netherlands, Germany and China - this test travels the world before it gets to your door. 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 receiving an “A” grade from the US Food and Drug Administration. is the final step in the process. Beautiful, thick, clear, rose-colored bands set Pinnacle’s FIT product apart from other tests. Often times physicians and nurses will perform rapid, in-vitro diagnostic tests and find themselves wondering “Is this a positive result or not?” Our FIT product simply doesn’t have that issue, as it is as decisive as it is accurate. So much so the FDA granted Pinnacle 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 ease of use is the final step in the process. Thick, clear, rose-colored bands set Pinnacle’s FIT product apart from other tests. Often times physicians and nurses will perform rapid, in-vitro diagnostic tests and find themselves wondering “Is this a positive result or not?” Our FIT product simply doesn’t have that issue, as it is as decisive as it is accurate. So much so the FDA granted Pinnacle 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%.