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FDA Clears Baebies' Newborn Screening Platform

NEW YORK (360Dx) – The US Food and Drug Administration has given de novo clearance of Baebies' Seeker platform for quantitatively measuring the activity of lysosomal enzymes α-L-iduronidase, α-D-glucosidase, β-glucocerebrosidase, and α-D-galactosidase A from newborn dried blood spot specimens, the company said recently.

Reduced activity of these enzymes may suggest lysosomal storage diseases (LSD) mucopolysaccharidosis type 1, Pompe, Gaucher, or Fabry, Baebies said. It added that Seeker is the only FDA-authorized test on the market for LSDs.

Baebies said that Pompe disease and MPS 1 were recently added to the recommended uniform screening panel (RUSP), a list of conditions for which it is recommended that every baby be screened.

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