While the fecal immunochemical test is considered the standard of care in asymptomatic, population-based colon cancer screening¹, concern of hemoglobin degradation rates, or the rate at which the biomarker dissipates in the collection tube due to time and temperature. Temperatures above 86º F are not recommended according to manufacturing instructions, affecting FIT samples significantly. Recently, studies show samples in summer months conclude far fewer positives than colder months according to Chausserie et. al. in "Seasonal variations do not affect the superiority of fecal immunochemical tests over guaiac tests for colorectal cancer screening." Second Generation FIT® ensures 0.0% hemoglobin degradation, when performed and interpreted at the point of care according to the package insert.
Colorectal cancer kills almost 53,000 people in the U.S. every year — men and women equally, and no one is immune. While therapies to treat colon cancer have improved, our strongest weapon against this deadly disease is reliable colorectal cancer testing and early detection. With early detection, five-year survival rates are above 90%. Once the disease has progressed to other organs and systems of the body, survival rates fall to 14%. Second Generation FIT® is changing the outcomes of colon cancer with simplified testing for all, designed to get the right people to colonoscopy.
Fecal immunochemical tests detect colon cancer, diverticulitis, colitis, Crohn’s disease, and other lower GI disease states by looking for nano particles of a protein in blood, — a universally accepted biomarker for colorectal cancer et. al. While colonoscopies are generally recommended for those age 45 and over, the truth is that many younger people are discovering they have early stage colorectal cancer, and the FIT test is an easy detection method. Many people were shocked by the death of Black Pantherstar Chadwick Boseman at the age of 43 from colon cancer. A tragedy like this just underscores the necessity of an annual at-home colon cancer test - no matter your age.
National guidelines suggest a fecal immunochemical test (FIT) can be used as the primary noninvasive screening modality for early-stage colorectal cancer, but a significant proportion of patients still receive a more expensive alternative test called Cologuard®.¹ Data used for national screening guidelines has shown no difference between the two tests at detecting adenoma versus colorectal malignancy.² These results align with previous studies out of Japan and the Netherlands examining FIT as an appropriate screening modality that is more cost effective than other types of noninvasive colorectal screening tests.³
¹ ² ³ Rao, PK et al. Comprehensive Cost Implications of Commercially Available Non-invasive Colorectal Cancer Screening Modalities: American College of Surgeons Clinical Congress 2022.
The company was founded in 2011 and started producing consumer tests in 2016. The FIT test can be ordered over-the-counter for use in testing for blood in the stool. Pinnacle BioLabs indicates that its test detects globlin (proteins found in blood) levels at 50 ng/mL (50 billionths of a gram) with 98% sensitivity and 96% specificity.
Their test has been the bestselling colon cancer screening test in the United States for 6 consecutive years. Pro's of the Second Generation FIT® test include it's OTC designation with the US Food and Drug Administration, it's affordability compared with similar products, ease of use, easy to find, and the fastest results.