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.

To read the full story....

Register for Free.

...and receive Daily News bulletins.

Already have an account?
Login Now.