The newborn screening (NGS) is conducted for all newborns throughout Germany (>99%). It serves the early detection of congenital metabolic, hormonal, blood, immune, and neuromuscular diseases, as well as cystic fibrosis in newborns. The goal is to identify the diseases early, before they lead to serious damage, disabilities, or even death, and to initiate timely treatment.
Guideline Change 05/2025
The last amendment to the child guidelines was adopted on May 15, 2025. The screening portfolio will be expanded from the previous 16 diseases by 4 additional diseases: 17. Vitamin B12 deficiency, 18. Homocystinuria, 19. Propionic acidemia, 20. Methylmalonic aciduria by May next year.
A successful implementation of these specific requirements can only be realized if sufficient measurement time is provided on the mass spectrometers (MS). Since the rapid processing of samples in NGS is of essential importance, all analytical methods must be available in sufficient quantity. The two current MS are fully utilized by the daily routine analytics of NGS as well as by maintaining the previous second-tier methods of NGS and other parameters of the central laboratories.
In order to meet the innovations of the G-BA, the newborn screening therefore requires another mass spectrometer as soon as possible.
LOT-0001
55/2025/EU/E15
Mass Spectrometer.
The newborn screening (NGS) is conducted for all newborns throughout Germany (>99%). It serves the early detection of congenital metabolic, hormonal, blood, immune, and neuromuscular diseases, as well as cystic fibrosis in newborns. The goal is to identify the diseases early, before they lead to serious damage, disabilities, or even death, and to initiate timely treatment.
Guideline Change 05/2025
The last amendment to the child guidelines was adopted on May 15, 2025. The screening portfolio will be expanded from the previous 16 diseases by 4 additional diseases: 17. Vitamin B12 deficiency, 18. Homocystinuria, 19. Propionic acidemia, 20. Methylmalonic aciduria by May next year.
A successful implementation of these specific requirements can only be realized if sufficient measurement time is provided on the mass spectrometers (MS). Since the rapid processing of samples in NGS is of essential importance, all analytical methods must be available in sufficient quantity. The two current MS are fully utilized by the daily routine analytics of NGS as well as by maintaining the previous second-tier methods of NGS and other parameters of the central laboratories.
In order to meet the innovations of the G-BA, the newborn screening therefore requires another mass spectrometer as soon as possible.