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# FDA Permits Marketing of Infant Seeker System
- URL: https://www.fdaweb.com/fda-permits-marketing-of-infant-seeker-system/
- Published: 2017-02-03T12:00:00.000Z
- Updated: 2026-09-14T22:04:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137903

FDA has permitted the marketing under the de novo process of Baebies Inc.’s Seeker System for screening four rare Lysosomal Storage Disorders (LSDs) in newborns. The device is designed to detect [Mucopolysaccharidosis Type I](http://email.prnewswire.com/wf/click?upn=Ga2Uazj4xWUc06Nd0K6Y2z1MXhhxESkot9OlwT2-2BJ4lK-2BClwTKiJN2NIFu94JaQu1YiViB4kkQe-2FJd3r-2FjzkIgDqFCQUwLPHmvJ-2FZAQrLH0-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuCby4jCYn1BqBLhxVvmmOdVrq7WzZ1jO6vChJLbG0ZRcCqF8705ioxVsfH0DMrq-2BjwG9lE1yjToxO8KP-2Byb5x7L68hLeqcL-2BAzYbGuFvjfIZMRnq27AL1TBrb9-2BuOvdQfpBdBW80QV7pgozGECEAhOLjEsx9JAJr-2BOpDmNyHD2ylbOBkdXBdLhQNT55Y5w-2Bf4fKIk7lLmvyYHPKrKnelbIOJAE06SJosJBtSU0Th4fczPApaVhWUI1JJAhac3sls-2F-2FlmhLbEaGrgFjAR9F-2FbjcA-3D-3D&ref=fdaweb.com) (MPS I), [Pompe](http://email.prnewswire.com/wf/click?upn=Ga2Uazj4xWUc06Nd0K6Y2z1MXhhxESkot9OlwT2-2BJ4kO-2F7yGUTQcD0UdoriwT4JrAvrbk5bUm-2FKy4r-2FaycNAEw-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuCby4jCYn1BqBLhxVvmmOdVrq7WzZ1jO6vChJLbG0ZRcCqF8705ioxVsfH0DMrq-2BjwG9lE1yjToxO8KP-2Byb5x7L68hLeqcL-2BAzYbGuFvjfIZMRnq27AL1TBrb9-2BuOvdQfnOgRkDjynsUxkuLKH73cOeHXvCKOlXm5qr6oVy8bh-2BqptoFbEhiX1YNszqKVim31DDa8tj-2BNEZXhQb37DQ-2BvzdeJEE0fUXWmeLEEtjYJrU0tyRa5fybBd459xKO71s3ywP1NRcsKI9SJGF10w-2BEA4g-3D-3D&ref=fdaweb.com), [Gaucher](http://email.prnewswire.com/wf/click?upn=Ga2Uazj4xWUc06Nd0K6Y2z1MXhhxESkot9OlwT2-2BJ4kho81NSWYxZCF-2F92c-2F471kAECryJ04oiPbPpE50WDVZQ-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuCby4jCYn1BqBLhxVvmmOdVrq7WzZ1jO6vChJLbG0ZRcCqF8705ioxVsfH0DMrq-2BjwG9lE1yjToxO8KP-2Byb5x7L68hLeqcL-2BAzYbGuFvjfIZMRnq27AL1TBrb9-2BuOvdQfsN5USE8TyC1nMUDN7Vdh-2BMr5O2iI3aehxkbK4cTOF-2FpTFThgoNny15-2FJX36IYamVVxQpOmy41BCgCVieR5d9sSpwQhRq9SNRyrcqNMWYOYoEwrxV4LY13dlQIb7mK0fnjIF-2Bj76zKZ-2BPSeW28-2BKdbQ-3D-3D&ref=fdaweb.com) and [Fabry](http://email.prnewswire.com/wf/click?upn=Ga2Uazj4xWUc06Nd0K6Y2z1MXhhxESkot9OlwT2-2BJ4mDR88ZjjII4eAVDDe-2Bl2IxH72HHWbgYn-2F1jG-2B7FNxmyA-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuCby4jCYn1BqBLhxVvmmOdVrq7WzZ1jO6vChJLbG0ZRcCqF8705ioxVsfH0DMrq-2BjwG9lE1yjToxO8KP-2Byb5x7L68hLeqcL-2BAzYbGuFvjfIZMRnq27AL1TBrb9-2BuOvdQfnUsHKlyyBDkp0UjSd8vRbdV1fHkpVtx6aD11DZWl8EbDXmDB4K9DX0R4QB7XtwgG94djWyOF-2FzNTE-2FKazL9-2FpklB-2FgjCIHUhOl82t8jArUcPFCy9bV-2BBJ2ExwbPfzr-2BRd7DndRDKucjPL1d3fSU8sw-3D-3D&ref=fdaweb.com). It is the first newborn screening test permitted to be marketed by FDA for these disorders, an [agency release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm539893.htm?ref=fdaweb.com) says. “LSDs are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body’s cells are not at normal levels or functioning properly,” it says.

  
The Seeker System works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from a newborn’s heel 24 to 48 hours after birth. “Reduced enzyme activity of proteins associated with any of the four LSDs detected by the kit may indicate presence of a disorder,” the agency says. “Results showing reduced enzyme activity must be confirmed using other testing methods, such as biopsies, genetic and other laboratory tests.”