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 CLIA certified laboratory and a US Food and Drug Administration certified manufacturer of in vitro diagnostic test kits. Pinnacle BioLabs in a federally licensed manufacturer of in vitro diagnostics testing, US FDA registration number: 3010982075. Pinnacle BioLabs is a CLIA licensed lab, CLIA license number: 44D2125377. Our National Provider Identification (NPI number) is 1497269120.
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 were one of the first companies to pioneer 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. Pinnacle BioLabs has been named one of the top ten companies in the world battling colorectal cancer. We own patents and intellectual property in the in vitro diagnostic testing market covering diabetes, colon cancer, drug screening, kidney and liver disease states and fertility testing.