• This test expands Roche's early diagnostics portfolio by screening for Spinal Muscular Atrophy (SMA), Severe Combined Immunodeficiency Disease (SCID), and Sickle Cell Disease (SCD) simultaneously.
• Catching these conditions shortly after birth empowers clinicians to choose life-changing treatments sooner, before irreversible symptoms or permanent damage manifest.
• The IVDR-approved test provides private and academic hospital laboratories with a ready-to-use solution that easily integrates into existing workflows. 

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced that TIB MOLBIOL, a subsidiary of Roche Diagnostics, has launched the LightMix® Newborn TREC/SMN1/HBB kit, an in vitro diagnostic test for newborn screening in countries accepting the CE mark. The test simultaneously screens for Spinal Muscular Atrophy (SMA), Severe Combined Immunodeficiency Disease (SCID), and Sickle Cell Disease (SCD). This launch provides a crucial, ready-to-use solution for private and academic hospital labs, enabling the early detection of devastating conditions to drastically improve patient outcomes.

"When a baby is born with a condition like SMA or SCID, every single day counts," said Marcus Droege, CEO of TIB MOLBIOL. "Catching these diseases before symptoms appear isn't just about early diagnosis; it's the difference between a child thriving or facing severe, lifelong disability. By expanding our compliant newborn screening tools across Europe, we are helping laboratories transition to high-precision solutions that ensure no critical diagnosis is delayed."

Early diagnosis empowers clinicians with clear, actionable information, providing answers for patients and their families and enabling them to access the appropriate treatments sooner.  This screening test exemplifies Roche's integrated approach to healthcare by acting as a first-tier trigger for immediate follow-up testing and therapeutic intervention.

For example, after identifying SMA, a rare disorder causing progressive muscle weakness and nerve degeneration, at birth, clinicians can immediately initiate treatment with targeted therapies. Catching SMA early may halt severe nerve damage, prevent permanent disability, and allow for normal growth milestones¹.

Similarly, early detection of SCD allows for timely interventions, including preventive penicillin and specialised immunisations, which can drastically lower infant mortality².  In conditions like SCID, historically known as "bubble boy disease", infants lack a functioning immune system and are highly susceptible to severe infections. Early detection allows for lifesaving treatments such as bone marrow transplants before dangerous infections occur³.