 |
| Seeker Instrument |
The U.S.Food and Drug Administration permitted marketing of the Seeker System for the
screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns on
February 3,2017.[i]
It is the
first newborn screening test permitted by FDA to diagnose Mucopolysaxxharidosis
type1 (MPS), Gaucher, Pompe and Fabry. These are a group of lysosomal disorders
(LSD) and are often under diagnosed because of the multisystem involvement of
many organs.
According to
the U.S. Department of Health and Human Services’ Advisory Committee on
Heritable Disorders in Newborns and Children, MPS I, Pompe, Gaucher and Fabry
occur in approximately 1 in 1,500 to no more than 1 in 185,000 newborns and
children, depending on the disorder. If not detected and treated in a timely
manner, these disorders may cause permanent organ damage, neurological
disability or death.
Currently each
US state have its own newborn screening program that includes hearing test, screening
for congenital heart diseases and endocrinal and metabolic disorders. Several
state mandate Lysosomal storage disease screening however, until the Seeker
System got clearance there were no FDA-authorized devices for screening of
these disorders.
Seeker
measures the activity of lysosomal enzymes from newborn dried blood spot
specimens collected from heel prick 24-48 hours’ afterbirth. Reduced enzyme activity
of these proteins may be indicative of a lysosomal storage disease listed above.
Seeker system
received de novo clearance because of its novel technology, low risk and lack of similar approved device in markets
currently. FDA also evaluated data from a clinical study 154,412 newborns in
Missouri whose dried blood samples were tested for protein activity associated
with MPS I, Pompe, Gaucher and Fabry. The system correctly identified one of each
four diseases in the newborns screened, with no false negative results after
15months of follow up.
The Seeker
System was created with funding from the Small Business Innovation Research program in National
Institutes of Health’s Eunice Kennedy Shriver National Institute of Child
Health and Human Development. It is manufactured by Baebies Inc., located in
Durham, North Carolina.
 |
| Seeker Workstation |
For more information contact:
Sales
Support
+1 (919) 328-8320
info@baebies.com
+1 (919) 328-8320
info@baebies.com
Yes, there is a necessity of neonatal screening for lysosomal storage disease as many infants in our country do suffer from G I upsets . I believe few of them -who suffer from long term G I upsets may have such cong deficiency? What will be treatment-can U pl highlight? Brief overview in few lines pl.
ReplyDelete