Baebies receives FDA clearance for newborn screening

Baebies, producers of newborn screening and pediatric testing, has received de novo clearance from the U.S. Food and Drug Administration (FDA) for SEEKER.

SEEKER is a quantitative measuring tool for lysosomal enzymes α-L-iduronidase (IDUA), α-D-glucosidase (GAA), β-glucocerebrosidase (GBA) and α-D-galactosidase A (GLA) from dried blood samples. These additions to newborn testing aims to bolster early detection of diseases.

"Although these lysosomal storage diseases (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," said Vamsee Pamula, president of Baebies. "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 authorized test on the market."

"As LSDs are being added to the recommended uniform screening panel, state newborn screening programs are making plans to begin screening. FDA clearance enables state laboratories to confidently implement testing while minimizing the validation effort resulting in a cost effective implementation," said Bradford Therrell Jr., PhD, director of the National Newborn Screening and Global Resource Center.