Epalinges, Switzerland, March 5, 2026 – Novigenix SA, a leader in immunotranscriptomic diagnostics, today announced the formal spin-out and launch of Novigenix AI, a new precision medicine company dedicated to transforming therapy development through AI-powered immune intelligence.

A Strategic Separation to Unlock Two High-Growth Markets

The new AI spin-out separates Novigenix’s colorectal cancer (CRC) screening business from its rapidly growing AI-driven biopharma and precision medicine platform, allowing each entity to pursue focused go-to-market strategies, tailored capital structures, and distinct partnership pathways.

Novigenix SA will continue advancing its CRC screening portfolio, including the Colox® and ColoxNGS® assays, distributed through Diagnosuite™ and clinical laboratory partners.

Novigenix AI will exclusively commercialize the LITOSeek® platform for biopharma, biotech, and precision medicine clinical applications globally.

“The tumor is only half the story. To deliver truly personalized medicine, we must understand how the patient’s immune system responds to disease and therapy. Spinning out Novigenix AI enables laser-focused investment, faster market penetration, and greater value creation for our shareholders and biopharma partners. This is the beginning of a new era in immune intelligence,” says Brian B. Hashemi, Ph.D., MBA, CEO & Chairman, Novigenix AI.

LITOSeek®

Dr. Miro Venturi, a board member of Novigenix AI and veteran in precision medicine and drug development says, “New therapy development is often compromised by heterogeneous patient response and sub-optimal clinical benefit, as well as severe grade 3-4 adverse events. The AI-enabled liquid biopsy solution of Novigenix AI provides longitudinal visibility into patient immune function to support translational medicine teams to effectively address these challenges.”

At the core of Novigenix AI is LITOSeek®, the first AI-powered immune intelligence platform designed to decode the systemic immune response longitudinally from simple blood samples. By analyzing immune-derived RNA using advanced machine learning, the platform transforms complex liquid biopsy data into clinically actionable insights. The platform supports tracking immune health, therapeutic response, resistance mechanisms, and adverse event risks in real time by providing:

  • ImmunoPharmacoDynamic (ImmunoPD™) response markers for longitudinal monitoring
  • Mechanistic insights into drug action and resistance
  • Predictive biomarkers of therapy response and resistance
  • Early indicators of immune-related toxicities and adverse events
  • Digital cytometry and cellular deconvolution powered by machine learning
  • A Scalable, cloud-based SaaS analytics integration

LITOSeek® is ISO 13485 certified and built for standardized, reproducible deployment across biopharma clinical trials and research environments—with secure cloud analytics infrastructure and de-centralized data-generation capabilities ensuring global readiness from day one.

Strong Commercial Traction and Validated Partnerships

Novigenix AI launches with established revenue and a proven commercial track record. While initial commercialization is centered on oncology, the platform’s immune intelligence capabilities extend to autoimmune, neurological, and other immune-mediated disease areas—creating a long-term expansion opportunity across multiple therapeutic categories.

About Novigenix AI

Novigenix AI is a Switzerland-based precision medicine company pioneering AI-powered immune intelligence. Its LITOSeek® platform analyzes blood RNA to generate predictive and mechanistic insights that guide therapy development, patient stratification, and clinical decision-making. The company is ISO 13485 certified and operates with global deployment capabilities across the U.S. and Europe.