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.