Roche subsidiary launches newborn screening test in Europe

Roche announced on Sept. 30, 2026, that its diagnostics subsidiary TIB MOLBIOL launched the LightMix Newborn TREC/SMN1/HBB kit. The in vitro diagnostic test is designed for newborn screening in countries that accept the CE mark, expanding Roche's early diagnostics offering.

The IVDR-approved diagnostic kit runs on established LightCycler systems and provides a ready-to-use option for private and academic hospital laboratories. It screens simultaneously for three severe genetic conditions: Spinal Muscular Atrophy, Severe Combined Immunodeficiency, and Sickle Cell Disease.

Marcus Droege, CEO of TIB MOLBIOL, stated that catching these diseases before symptoms appear can prevent severe, lifelong disability and noted that the company is expanding compliant newborn screening tools across Europe to ensure laboratories avoid delays in critical diagnoses.

Early detection enables healthcare providers to initiate targeted therapies rapidly. Interventions include immediate therapies for spinal muscular atrophy, bone marrow transplants for severe combined immunodeficiency before dangerous infections take hold, and preventive penicillin or specialised immunisations for sickle cell disease.