Baebies has bagged the FDA’s de novo clearance for its newborn screening device that detects lysosomal storage diseases, such as Gaucher, Pompe and Fabry disease.
The Seeker device quantitatively measures the activity of four lysosomal enzymes in newborn dried blood spot specimens, according to a statement. Decreased activity of these enzymes, which include α-L-iduronidase and α-D-glucosidase, can indicate the presence of lysosomal storage diseases.
Lysosomal storage diseases refer to a group of about 50 rare, inherited disorders stemming from dysfunction in the lysosomes—organelles that contain enzymes to break down large molecules.
While these diseases have FDA-approved treatments, Seeker is the first FDA-cleared device that screens for them, said Baebies President Vamsee Pamula. “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,” he said.
Each year, more than 4 million babies born in the U.S. undergo screening for congenital disorders, according to the American Academy of Pediatrics. Approximately 4,000 infants are diagnosed with conditions each year, while about 1,000 have conditions that go undetected. The lysosomal diseases Pompe and mucopolysaccharidosis type I were recently added to the Recommended Uniform Screening Panel.
"As LSDs are being added to the RUSP, state newborn screening programs are making plans to begin screening,” said Bradford Therrell Jr., director of the National Newborn Screening and Global Resource Center. “FDA clearance enables state laboratories to confidently implement testing while minimizing the validation effort resulting in a cost effective implementation."
Baebies is also working on a device, dubbed Finder, that will perform tests on "tiny droplets of blood." While it isn't cleared for use in any market, the company expects it to cut down on testing time, making it suitable for time-sensitive tests.