An FDA advisory committee unanimously agreed that Baebies’ Seeker analyzer should be approved to detect lysosomal enzymes in newborns.
The Clinical Chemistry and Toxicology Devices Panel had originally expressed concerns about false positives and negatives associated with the diagnostic test, but it ultimately decided that the benefits outweighed the risk and the Instruction for Use statement could indicate the limitations.
Baebies, Inc. is seeking a de novo classification for the system, which includes the Seeker analyzer, the Seeker 4-plex assay kit, Seeker cartridges, the Spot Logic software and quality control materials. The diagnostic uses digital microfluidic technology to measure lysosomal enzymes associated with Mucopolysaccharidosis Type 1 disease, Pompe disease, Gaucher disease and Fabry disease.
Reduced activity for any of the four enzymes identified should be followed up by other confirmatory diagnostics, the agency said.
The test does have numerous limitations. For example, enzymes vary by age and by seasons since enzymes are impacted by temperature and humidity. Thus, the Instructions for Use statement should recommend that users set their own cutoffs, the panel recommended.
Limitations were also noted with analytical performance of the device around the high risk cutoff. The panel noted that it was “somewhat concerned” with the analytical performance but concluded that it was adequate to support its proposed intended use within the limited population. — Tamra Sami