At a Glance: The Pinnacle BioLabs Second Generation FIT® test is reliable, accurate, and affordable. As the #1 selling colon cancer screening test in the United States for six straight years, the Second Generation FIT® Fecal Immunochemical Test is a proven and recommended colon cancer screening test used by doctors and hospitals nationwide - now available over-the-counter. The test is easy to perform in the comfort of your own home and results are ready within five minutes. With Second Generation FIT®, no prescription, doctors visit, or mailing a sample back to a laboratory is required. Second Generation FIT® is tax free and ships free.
Second Generation FIT® is an at-home colon cancer screening test utilizing the same biomarker as our clinical kits - used by doctors and hospitals nationwide - bringing laboratory-grade diagnostics direct to your home. Second Generation FIT® detects globin antibodies at cutoff levels of 50 ng/mL, or 50 billionths of a gram with 98% sensitivity and 96% specificity.
Colon Cancer Kills
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 screening 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 screening for all, and getting the right people to colonoscopy.
Getting Tested Is Key
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 Panther star 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.
At Home Testing vs. Colonoscopy
The FIT test is considered as effective a screening tool for colorectal cancer as a colonoscopy according to the most recent American College of Gastroenterology Colon Cancer Screening Guidelines. Colonoscopies can be very disruptive to daily life for asymptomatic screening, with multi-day preparatory period in which you are allowed to eat very little, and a notorious bowel preparation (colon cleaning part of the process) regimen. With Pinnacle's at home FIT test, the entire process takes five to ten minutes, with results that approach the diagnostic accuracy of colonoscopy.
In 2014, the Second Generation FIT® test was FDA cleared to aid in the detection of colorectal (colon) cancer, colitis, diverticulitis and other lower GI disease states. There are no diet restrictions, no medicine restrictions and the entire test is performed in the privacy of your own home in about five minutes. Additionally, Second Generation FIT® does not require a prescription or doctor’s visit.
Second Generation FIT® and other fecal immunochemical tests have been used in clinical settings in large hospitals and teaching institutions with great success. The FIT test has been featured in more than one hundred studies, which has lead to the American College of Gastroenterology, the American Gastroenterological Association, the US Joint Preventative Task Force and the American Cancer Society recommending FIT for colon cancer screening, with outcomes similar to screening with colonoscopy. Continue reading to see how the Second Generation FIT® test is changing the landscape of colon cancer screening for all average risk people.
Unfortunately, only 58% of the population is current with CRC screening. It is estimated that new CRC cases (actual instances of colon cancer) would drop by 277,000 if 80% of the population would be current, with another 203,000 deaths prevented. As you would guess, screening rates are dangerously low at only 20% for under-insured persons and 37% for people with no high school diploma. Second Generation FIT® is the only test that breaks down these financial barriers and socio-economic barriers.
A positive Second Generation FIT® should almost always be followed up with a colonoscopy. Consult a physician with your results. The FIT test is designed to look for human globin antibodies, part of hemoglobin - the top bio-marker for colon cancer, diverticulitis, colitis, and other lower GI disease states. The Second Generation FIT® test is highly sensitive, designed to illicit a positive result at just 50 nanograms of globin. Studies show that any positive FIT test should be followed up with colonoscopy and a good goal is two to three months from the positive FIT. Remember, only a colonoscopy can prevent or cure colon cancer as a physician can excise polyps during the procedure. The goal of Second Generation FIT® is to get the right people to colonoscopy. If your results are negative, the next step is to simply re-test in 12 months.
The Second Generation FIT® test is over-the-counter cleared for home use, but it is also used by hospitals, laboratories and physician’s offices around the country and around the world. Pinnacle BioLabs is an FDA registered manufacturer of in vitro diagnostic tests and the Second Generation FIT® test is designed in Nashville, TN and manufactured entirely in the United States of America.
If you have a family history of colorectal cancer, your physician may recommend colonoscopy ten years prior to the onset of your family member’s cancer diagnosis. There are other medical conditions you may have which make this the right choice.
Second Generation FIT® is the affordable, accessible test available without a prescription that is right for most average risk persons. Results are easy to interpret and the test can be performed quickly and intuitively with easy-to-understand instructions. Experts agree that the best colon cancer test is the one that gets done, which is why you can find Second Generation FIT® at CVS stores, RiteAid stores, walmart.com, amazon.com, and always our best price, tax free and with free shipping on our flagship site.
For screening, people are considered to be at average risk if they do not have:
Cancer prevention tests have the potential to image both cancer and polyps, whereas cancer detection tests have low sensitivity for polyps and typically lower sensitivity for cancer compared with that in cancer prevention tests (imaging tests). The ACG supports the division of screening tests into cancer prevention and cancer detection tests, but recommends a preferred cancer prevention test—colonoscopy every 10 years (Grade 1 B) and a preferred cancer detection test—annual fecal immunochemical test (FIT) to detect occult bleeding (Grade 1 B). Full text at https://gi.org/guidelines/
The MSTF has recently issued detailed recommendations on the technical performance of FIT and considers FIT an essential element of the CRC screening armamentarium for all practitioners. FIT is commonly the test of choice in programmatic screening, an excellent second choice for practitioners using sequential testing who offer colonoscopy first, and should likely always be one of the tests included in a multiple-options approach. Disadvantages of FIT include the need for repeated testing, which can be problematic in the non-programmatic (opportunistic) setting, and poor or no sensitivity for serrated class precursor lesions. However, there is no evidence that cancers arising through serrated class lesions are less likely to bleed than those arising via adenomas. Full text at https://www.gastro.org/practice-guidance/gi-patient-center/topic/colorectal-cancer-crc