FDA Approves Screening System that Detects Metabolic Disorders in Newborns
The Food and Drug Administration has approved the marketing of the Seeker System (Baebies, Inc.) for the screening of four rare lysosomal storage disorders (LSDs) in newborns.
The Seeker System is the first newborn screening test FDA-cleared to detect Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher, and Fabry disease. It includes the Seeker LSD Reagent Kit- IDUA|GAA|GBA|GLA and the Seeker Instrument, which measures the activity level of proteins needed for healthy lysosomal storage found in dried blood samples from a newborn's heel 24–48 hours after birth. The Instrument automates the analysis of the dried blood spots. If there is decreased enzymatic activity of the proteins associated with any of the four LSDs, it may indicate the presence of a disorder. These results need to be confirmed using other methods such as biopsies, genetic tests, and other laboratory tests.
The FDA reviewed data from a clinical study (n=154,412) of newborns in Missouri whose dried blood samples were tested for protein activity for MPS I, Pompe, Gaucher, and Fabry. Efficacy was established because the Seeker System was able to accurately detect at least one of the four LSDs in 73 of the newborns who were screened. The Missouri State Public Health Laboratory also conducted active surveillance of four of the state's metabolic centers for new diagnoses of these disorders. To determine cases of false negatives that were not detected during the study, the surveillance activities continued for 15 months after the study's completion. No false negative results were found through the study or through Missouri's 15-month surveillance program.
Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, added, "Accurate screening tests will help with early detection, treatment and control of these rare disorders in newborns, before permanent damage occurs. That's why availability of LSD screening methods that have been assessed for accuracy and reliability by the FDA are so important."
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