ImmunoIVD

Executive Summary

ImmunoIVD is a Swedish diagnostics company focused on newborn screening for rare, life-threatening diseases. Founded in 2016, the company has developed CE-marked in vitro diagnostic assays under its SPOT-it™ product line, targeting conditions such as Severe Combined Immunodeficiency (SCID), Spinal Muscular Atrophy (SMA), and X-linked Agammaglobulinemia (XLA). The assays are designed for routine screening laboratories, requiring minimal equipment and space, thus enabling broad accessibility. By enabling early detection, ImmunoIVD’s kits address a critical unmet need in neonatal care, potentially improving outcomes for affected infants. The company's mission aligns with global trends toward expanded newborn screening programs, positioning it well in a growing market that values simplicity and reliability.

Upcoming Catalysts (preview)

• Q3 2026U.S. FDA 510(k) submission for SPOT-it SCID assay60% success
• Q4 2026Commercial partnership for European distribution expansion70% success
• Q1 2027Launch of next-generation SPOT-it multiplex assay covering additional diseases50% success