Roche Holding announces newborn screening test launch

Roche said its subsidiary TIB MOLBIOL launched a newborn screening kit in countries accepting the CE mark. The test screens simultaneously for three severe genetic conditions.

Roche said on September 30, 2026, that TIB MOLBIOL, a subsidiary of Roche Diagnostics, launched the LightMix® Newborn TREC/SMN1/HBB kit in countries accepting the CE mark.

Newborn screening launch

The in vitro diagnostic test is designed to screen simultaneously for Spinal Muscular Atrophy, Severe Combined Immunodeficiency and Sickle Cell Disease. According to the company release, the IVDR-approved kit is intended for private and academic hospital laboratories and runs on established LightCycler systems.

Roche diagnostics portfolio

Roche’s media releases describe the company as operating across diagnostics and pharmaceuticals. TIB MOLBIOL is headquartered in Berlin and supplies molecular PCR assays for medical diagnostics, research and industrial manufacturing, according to the release.