The Nonequivalent “Equivalent Cutoff”

Newborn screening of lysosomal storage disorders (LSDs) can be performed using different methods, workflows, screening algorithms, assay protocols, reagents/kits and instruments, all of which impact the output of the test. “Equivalent cutoff” has been proposed as a method to normalize screening results across LSD screening platforms. In this white paper, we review the validity of the recently proposed “equivalent cutoff” and the critical shortcomings in the effectiveness of this idea, including how it ignores the cardinal rule of newborn screening: to minimize the chance of a false negative result.

Analytical Range is a Poor Metric for Comparing Newborn Screening Assay Performance

A major goal of any newborn screening laboratory is to adopt screening methods that best identify those at-risk for a particular disorder. Although the term analytical range has recently been presented as a metric for method performance comparison for newborn screening of lysosomal storage disorders, it is a poor comparator of assay platforms. Download our free white paper to learn why Z-factor is the superior metric over analytical range when comparing newborn screening assay performance.

Baebies Completes First Close on Series B Financing

Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced today it has completed a $5 million first close on its Series B financing. The company plans to raise an additional $5 million in the coming months. Baebies received clearance from the U.S. Food and Drug Administration (FDA) for its SEEKER newborn screening system earlier this month.

Baebies SEEKER FDA-Authorized Newborn Screening

Baebies Receives FDA de novo Clearance for First Lysosomal Storage Disease Newborn Screening Platform, SEEKER

Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced today it has received de novo clearance from the U.S. Food and Drug Administration (FDA) for SEEKER. SEEKER quantitatively measures the activity of lysosomal enzymes α-L-iduronidase (IDUA), α-D-glucosidase (GAA), β-glucocerebrosidase (GBA) and α-D-galactosidase A (GLA) from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of lysosomal storage diseases (LSDs) Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry, respectively.

FDA Advisors Back Approval of Baebies’ SEEKER Analyzer for Newborns

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 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.

Baebies to Exhibit and Display FINDER Prototype at 2016 AACC Annual Scientific Meeting

Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, today announced that the company will exhibit and display a prototype of FINDER at the 68th AACC Annual Scientific Meeting and Clinical Lab Expo. FINDER, currently under development, is a small, innovative and connected testing solution that uses a tiny blood sample to quickly perform time critical pediatric tests.

Baebies Appoints Former Medtronic CEO and Illumina Ventures Founding Partner to Its Board of Directors

Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, today announced that William A. Hawkins and Nicholas Naclerio, PhD have joined the company’s Board of Directors effective immediately. Mr. Hawkins is the retired Chairman and CEO of Medtronic, a world-renowned innovative medical technology company. Dr. Naclerio is the Founding Partner of Illumina Ventures, an early stage venture capital firm strategically aligned with Illumina, Inc.

Richard West honored with CEO of the Year Award

Richard West, CEO of Baebies, Inc was awarded with the 2016 Life Sciences CEO of the Year Award from Triangle Business Journal. The Triangle Business Journal hosted the 2016 Life Sciences Awards on Thursday, May 26, 2016 in Cary, North Carolina. The Life Sciences Awards recognize both individuals and research organizations that are breaking ground in this field. There are more than 600 life sciences companies in North Carolina, and the majority of them are either headquartered or have a significant presence in the Triangle, according to Triangle Business Journal.