Home >> MARKETPLACE >> FDA clears lysosomal storage disorder test

FDA clears lysosomal storage disorder test

Print Friendly, PDF & Email

September 2018—PerkinElmer has received FDA 510(k) clearance for its NeoLSD MSMS kit, an in vitro diagnostic that uses tandem mass spectrometry to screen for six lysosomal storage disorders in newborns via a single dried blood spot sample. The kit is intended for the quantitative measurement of the activity of the enzymes acid β-glucocerebrosidase, acid sphingomyelinase, acid α-glucosidase, β-galactocerebrosidase, α-galactosidase A, and α-L-iduronidase in dried blood spots from newborn babies. The test enables early diagnosis of LSDs including Gaucher, Niemann-Pick A/B, Pompe, Krabbe, Fabry, and MPS I.

PerkinElmer, 203-925-4602

x

Check Also

PerkinElmer buys Tulip Diagnostics, 4/17

April 2017—PerkinElmer has entered into a definitive agreement to acquire Tulip Diagnostics Private Ltd. Tulip, based in Goa, India, is a large domestic provider of in vitro diagnostic reagents, kits, and instruments to diagnostic labs and government and private health care facilities.

X