Biotechnology company Baebies has secured de novo clearance from the US Food and Drug Administration (FDA) for the use of its newborn screening platform SEEKER in diagnosis of lysosomal storage diseases (LSDs).
The new device is designed to quantitatively measure the activity of lysosomal enzymes α-L-iduronidase (IDUA), α-D-glucosidase (GAA), β-glucocerebrosidase (GBA) and α-D-galactosidase A (GLA) in dried blood spot samples of newborns.
The detection of a decrease in the activity of these lysosomal enzymes indicates the presence of LSDs such as Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry.
Baebies president and co-founder Vamsee Pamula said: "Although these LSDs have FDA approved therapies, this is a significant milestone for the LSD community, as SEEKER is the first FDA cleared product for LSD testing.
"FDA's clearance of SEEKER resulted from a thorough and rigorous review.
"We look forward to providing SEEKER kits to implement safe, effective, easy and reliable screening for LSDs. SEEKER is the only FDA authorised test on the market."
Initiated to ensure the screening of all babies for certain serious conditions at birth, the Newborn screening health programme currently includes more than 30 metabolic and genetic diseases.
The Pompe disease and MPS I were recently included in the Recommended Uniform Screening Panel (RUSP), enabling early detection of LSDs via newborn screening.
It is expected that the FDA clearance will allow to reduce the validation effort with the implementation of the cost effective screening.
Baebies develops new technologies and tests for advance newborn screening and pediatric testing.
Image: SEEKER Instrument. Photo: courtesy of Baebies.