Immuno Concepts

Immuno Concepts is a privately held, commercial-stage diagnostics company focused on autoimmune disease testing, particularly for systemic rheumatic diseases like lupus. Its core innovation is the HEp-2000® substrate, a genetically improved cell line that offers superior sensitivity for detecting key autoantibodies, supported by over thirty publications. The company has expanded its portfolio to include FDA-cleared tests and offers automation solutions like the Image Navigator® automated microscope and AFT pipetting stations to streamline laboratory workflow. With a quality system certified to ISO 13485:2016, Immuno Concepts has built a reputation over four decades on product quality, customer education, and technological advancement in immunofluorescence testing.

Patented HEp-2000® cell substrate (genetically engineered for SS-A/Ro sensitivity) combined with automated immunofluorescence systems including the Image Navigator® automated microscope and AFT pipetting stations.

Operates in the specialized autoimmune diagnostics segment, competing with large diversified diagnostics companies (e.g., Thermo Fisher, Werfen/Inova, Bio-Rad) and other specialty suppliers. Differentiates primarily through the clinically validated performance of its HEp-2000® substrate and its integrated automation solution, rather than competing on price or breadth of menu.