A new screening device called the Seeker System, which detects lysosomal storage disorders (LSDs) like Gaucher disease in newborns, has received de novo clearance from the U.S. Food and Drug Administration (FDA).
The de novo classification offers an alternative pathway to classify novel types of medical devices of low to moderate risk.
The FDA approved the Seeker System for the screening of four rare LSDs in newborns, namely Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher and Fabry diseases. This is the first newborn screening test available for these disorders.
LSDs are a consequence of malfunctioning enzymes that trigger the accumulation of toxins inside cells. The damage that results from this accumulation, particularly in neurons, might lead to learning, development and movement problems in children.
If physicians can screen for LSDs and detect them early, children might be able to receive appropriate treatment before the harm caused by the diseases is irreparable.
According to a press release, the Seeker System was developed with funding from a National Institutes for Health’s (NIH) Small Business Innovation Research program, at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The NICHD started supporting the development of the screening device 10 years ago, with a project designed to test the feasibility of screening for LSDs using dried blood spots, collected routinely after birth in several screening programs nationwide.
In 2013, the researchers had an important breakthrough and were able to demonstrate that the device could accurately detect several LSDs from a single dried blood spot. The process reportedly takes less than three hours from sample preparation to results and is faster than conventional methods for screening dried blood spots.
The FDA recently added Pompe and MPS I to its list of routine recommended newborn screening programs and anticipates that additional states will begin requiring use of screening tests to detect these disorders, according to Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
“Accurate screening tests will help with early detection, treatment and control of these rare disorders in newborns, before permanent damage occurs," Gutierrez said in an FDA press statement. "That’s why availability of LSD screening methods that have been assessed for accuracy and reliability by the FDA are so important."