False Positive Rate Comparison: SEEKER vs. NeoLSD

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:

  1. False positives require repeat tests which are costly.
  2. Getting babies back in to collect repeat DBS specimens is variable and generally not 100%.
  3. 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 cbrannen@baebies.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

Email Candice

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*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