Posted 11/4/2018 by Candice Brannen, PhD, Senior Director of Lab Products
At Baebies, we are striving to make innovative products with high reliability to ensure babies are given a healthy start. Our newborn screening platform SEEKER® was the first FDA-cleared product for screening of lysosomal storage disorders (LSDs) in February 2017.
Almost a year and a half later, a second product received FDA clearance for LSD screening: NeoLSD™. The FDA recently published the product’s clinical data that was submitted with the 510(k) application.
The chart below compares clinical trial data from both SEEKER and NeoLSD 510(k) submissions* for four LSDs: Pompe (GAA), MPS I (IDUA), Fabry (GLA), and Gaucher (GBA).
NeoLSD’s false positive rates are roughly double those of SEEKER. This data is consistent with the state labs’ experience as published in a series of letters to the editor by Duke University’s Dr. David S. Millington and Dr. Deeksha Bali.**
Higher false positive rates lead to higher costs for the labs and unnecessary stress on families in these ways:
- False positives require repeat tests which are costly.
- Getting babies back in to collect repeat DBS specimens is variable and generally not 100%.
- Parents and families experience psychological effects due to uncertainty.
For follow-up programs, additional and unnecessary communication to the families is required – this is often overlooked when considering the addition of a test. With only half the false positives, Baebies SEEKER saves time and money in comparison to NeoLSD.
Share this competitive comparison with your newborn screening network! Contact me by email email@example.com to:
- Discuss screening with SEEKER in your lab
- Schedule a presentation of this data at your next NBS advisory committee meeting
- Explore opportunities to collaborate with Baebies
*NeoLSD data obtained from 510(k) summary: NeoLSD K173829 (NeoLSD is a trademark of PerkinElmer.)
*SEEKER data obtained from 510(k) summary: SEEKER Newborn Screening System DEN150035
**Letter to the Editor: “Misinformation regarding tandem mass spectrometric vs fluorometric assays to screen newborns for LSDs”. MGM Reports. 2017. Authors: David S. Millington and Deeksha Bali