Pinnacle BioLabs is a privately held corporation started in 2011 as a point-of-care in vitro diagnostics manufacturer of colorectal cancer test kits, drug of abuse testing, and various other disease states via urinalysis. Pinnacle BioLabs is a US Food and Drug Administration certified manufacturer of in vitro diagnostic tests. US FDA registration number: 3010982075. Our National Provider Identification (NPI number) is 1497269120. Outside of the United States, Pinnacle has locations in Lagos, Nigeria. Learn more at https://coloncancer.africa In early 2020, Pinnacle BioLabs announced a novel COVID-19 Rapid Point of Care test to detect active infections in both symptomatic and asymptomatic patients, modeled on the Second Generation FIT® lateral flow immunoassay. Early results show ~90% Sensitivity and near ~100% specificity.
Recognizing socio-economic changes, Pinnacle’s OTC division received the first and only OTC clearance for a colon cancer detection test, the patented Second Generation FIT® test. Within three years of FDA clearance, Second Generation FIT® became the number one colon cancer test kit in both units sold and total revenue in North America. In addition to OTC testing for colorectal cancer, Pinnacle manufactures, sells and distributes Second Generation FIT® in a CLIA waived test kit to physician office labs and hospitals. The companies origins were in the colorectal cancer market, still reflected in its vision: A World Without Colorectal Cancer.
In 2016 we pioneered direct-to-consumer lab test kits, and continue to expand our at home lab test portfolio through HomeLab, the novel at-home small sample volume lab test that allows customers to test for a wide range of useful laboratory tests. Current tests available are PSA, TSH, cholesterol, hemoglobin A1C, lipids, and triglycerides. Developmental tests include food intolerance, allergy, and STD testing. In 2015 Pinnacle BioLabs has been named one of the top ten companies in the world battling colorectal cancer. We own intellectual property in the in vitro diagnostic testing market covering diabetes, colon cancer, drug screening, kidney and liver disease states and fertility testing.