Seraseq® Newborn DNA Mix SMA - Child

The Seraseq® Newborn DNA Mix SMA are genomic DNA reference materials intended for the development, validation, and routine performance monitoring of next-generation sequencing (NGS) (and other amplified nucleic acid-based methods) used in newborn screening.

This reference material has been built using immortalized maternal and fetal cell lines collected from a healthy pregnant patient carrying a fetus diagnosed with spinal muscular atrophy (SMA).

This material addresses the need for newborn screening reference standards that are sustainable, consistent, and readily available.

FEATURES AND BENEFITS

• Inheritance-ready sample design (duo option): material available as matched maternal + affected offspring (duo) to support evaluation of inheritance analysis in rare disease workflows.
• Designed for newborn screening workflows: helps labs establish assay accuracy, precision, sensitivity/LoD, and reproducibility using standardized, ready-to-use reference materials.
• Clinically relevant SMA content: includes confirmed clinically significant variants relevant to SMA screening/confirmation
• Sustainable, scalable supply: cell line–based approach supports lot consistency and ongoing availability for repeated validation and longitudinal QC.
• Manufactured under quality systems: produced in cGMP-compliant, ISO 13485-certified facilities with stringent release testing.