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August 15, 2018

Lab Considerations for Implementation of New Conditions (Webinar)

New conditions are consistently being added to the Recommended Universal Screening Panel (RUSP) and new tests are being developed to create a more comprehensive screening landscape. Dr. Michele Caggana, Director of the NY Newborn Screening Program, walks through the steps that a state laboratory should take as they consider introducing a new test.

Video
August 15, 2018

Pompe Disease and the Missouri LSD NBS Experience (Webinar)

Tomi Toler, a Genetic Counselor, discusses her experience working with families and children diagnosed with Lysosomal Storage Disorders (LSDs) at Children's Hospital St. Louis, which serves as a referral site for babies identified through Newborn Screening (NBS). This webinar from 2016 includes an overview of the history of LSD screening in Missouri, demographics for identified cases, referral protocols for each condition, and treatment options for LSDs.

Video
August 2, 2018

SEEKER | Workflow

Watch the lab workflow of Baebies SEEKER, an innovative FDA authorized and CE marked newborn screening platform for lysosomal storage disorders.

Video
July 25, 2018

Not ‘Just Interns’

At Baebies, we recruit interns who work on real business cases. Our interns don’t file papers or make coffee runs. They assist in research and development to help more babies have a healthy start. “Our interns contribute to research projects that lead to commercialized products,” said Lisa Nelson, Senior Scientist at Baebies and direct manager to several current interns. “Similar to hiring staff, we look for interns who are intellectually curious,  self-driven, and passionate about research. These qualities are essential to our mission to save lives, and make lives better for millions of children.” This summer we have 8 interns who are actively working on the expansion of our assay pipeline and on new product FINDER (currently under development).

Announcement
July 24, 2018

Legislative Wins for Newborns including North Carolina, Colorado

In 2018, Baebies supported advocacy efforts for expanded newborn screening, especially efforts that sought to make the process of adding conditions to states’ menus more efficient. We have also been closely tracking legislative activity across the United States, including 55 bills introduced this year that impacted newborn screening in some way. Baebies especially appreciated the win for newborns in our own home state of North Carolina where a new approach to keeping at parity with the Recommended Uniform Screening Panel (RUSP) was passed.

Announcement
June 6, 2018

Incidence of 4 Lysosomal Storage Disorders from 4 Years of Newborn Screening

The Missouri State Public Health Laboratory (MSPHL) recently published findings on incidence rates from 4 years of full population newborn screening for Pompe, MPS I, Gaucher and Fabry lysosomal storage disorders (LSDs) using the digital microfluidic platform SEEKER. The Missouri program is the longest-running prospective and un-blinded newborn screening and follow-up study of LSDs in the United States. In the first 4 years of LSD screening, the MSPHL identified 133 newborns who were confirmed through diagnostic testing to have one of the four LSDs. The incidence rates for Pompe and Fabry found in Missouri correlate well with results from Taiwan but are higher than recently reported incidence rates in Illinois. Incidence rates for Gaucher and MPS I correlate well to other pilot studies. The MSPHL has not identified any missed LSD cases to date.

Publication
June 1, 2018

Celebrating Shipment of 3,000,000th Test!

Baebies is celebrating the shipment of more than 3 million tests which translates to more than 3 million chances for a healthy start. We proudly share this milestone and our growth with babies everywhere.

Announcement
April 17, 2018

Electrowetting Droplet Operations on a Digital Microfluidic Cartridge

Simple droplet operations of dispensing from a reagent reservoir, droplet transport across electrodes, merging two droplets into a larger combined droplet, mixing the combined droplet, and splitting the droplet are accomplished by strategically applying voltages to electrodes on the cartridge printed circuit board.

Video
March 29, 2018

Baebies Supports Recommendation for Expanded Newborn Screening in NC

At Baebies, our mission drives us to support the acceleration of expanding newborn screening wherever and whenever possible. Baebies was mentioned in a recent report generated by the North Carolina Advisory Council on Rare Diseases called, “Newborn Screening and Early Intervention for the Treatment of Rare Diseases: A Win-Win for Children with Rare Diseases and North Carolina.” North Carolina pioneered universal screening of newborns using tandem mass spectrometry for metabolic disorders, developed at Duke University by Prof. David Millington (Baebies Advisor). The report, published earlier this year, highlights the ecosystem in NC comprising academia (Duke and UNC), non-profit (Research Triangle Institute), and industry (Baebies) that can drive innovations in newborn screening with significant impact for babies around the world.

Announcement
March 15, 2018

Understanding Enzyme Assays for Lysosomal Storage Disorders – The Influence of Substrate Concentration and Incubation Time (Part IV)

The fourth and final white paper in our series reviews several concepts of enzyme assays for lysosomal storage disorders (LSDs). To wrap up the series, Baebies examines all the factors that determine enzyme activity and highlights how enzyme assays can be performed with shorter incubation times without incurring additional cost or compromising assay performance. This is especially significant in the case of newborn screening of Pompe disease, where timely intervention results in better outcomes for the patients.

White Paper
November 30, 2017

Understanding Enzyme Assays for Lysosomal Storage Disorders – Integration of X-linked Adrenoleukodystrophy and SEEKER Workflows for Same-Day Referrals (Part III)

The recent additions of two lysosomal storage disorders (Pompe and MPS I) and a peroxisomal metabolic disorder (X-ALD) to the RUSP have led several labs to discuss adding these disorders to their screening panels. Our “Understanding Enzyme Assays for Lysosomal Storage Disorders” white paper series has examined key differences between enzymatic versus metabolic assays on digital microfluidics (FDA authorized) or tandem mass spectrometry (MS/MS) platforms. The series continues with a focus on the different screening methods for LSDs and X-ALD and how to optimize laboratory workflows when adding X-ALD.

White Paper
November 3, 2017

Understanding Enzyme Assays for Lysosomal Storage Disorders – How to Measure Product Formation (Part II)

Enzyme assays for lysosomal storage disorders (LSDs) are performed by using either digital microfluidics (FDA authorized) or tandem mass spectrometry (MS/MS) platforms. Part 1 of the “Understanding Enzyme Assays for Lysosomal Storage Disorders” series outlines the difference between natural and artificial substrates and how they are deployed on each platform. Although MS/MS platforms are often already installed in most labs for metabolic assays, key differences in assay protocols and workflows need to be evaluated to examine if it would be feasible to share the equipment. Part 2 of this series explains this further and examines the time it takes for each method workflow, including the steps and equipment necessary.

White Paper
October 31, 2017

Baebies Announces Completion of $10 Million Series B Financing

Baebies, a growth-stage company that delivers innovative products and services for newborn screening and pediatric testing, today announced that it has secured $10 million in Series B financing in an oversubscribed round anchored by BOE Technology Group Co., Ltd. BOE is a global leader in semiconductor display industry as well as an IoT company providing intelligent interface products and services for information interaction and human health. Baebies also received funding from family offices, with continued support from current investors and the North Carolina Biotechnology Center.

Press Release
October 13, 2017

Understanding Enzyme Assays for Lysosomal Storage Disorders – Synthetic Substrates (Part I)

High throughput testing of multiple lysosomal storage disorders (LSDs) from dried blood spots can be performed using digital microfluidics (FDA authorized) or tandem mass spectrometry. Although both methods use “artificial” substrates to perform enzymatic reactions, digital microfluidics runs each reaction at its optimal pH. Download this free white paper to learn key differences between natural and artificial substrates for LSD assays and how they are deployed on each platform.

White Paper
September 28, 2017

What is Infantile Onset Pompe Disease vs. Late Onset Pompe Disease? Baebies interviews Dr. Priya Kishnani

In our discussions with state public health laboratories, Baebies has observed confusion and ambiguity on the difference between Infantile Onset Pompe disease and Late Onset Pompe disease. We interviewed world-renowned expert on Pompe disease, Dr. Priya Kishnani, to disseminate insights into the clinical manifestations of Infantile Onset Pompe disease and Late Onset Pompe disease and to elucidate the significance of newborn screening for Pompe disease to public health laboratories who may be interested in adding Pompe disease to their screening panels. Dr. Kishnani is Division Chief of Medical Genetics and Director of the Y.T. and Alice Chen Pediatric Genetics and Genomics Research Center at Duke University Medical Center (DUMC). She also serves as Director of the Lysosomal Storage Disease Program, Biochemical Genetics Training Program and Metabolic Clinic at DUMC.

White Paper
September 8, 2017

Baebies Announces Partnership with Trivitron’s Labsystems Diagnostics to Bring Latest Technologies to Newborn Screening Worldwide

Baebies, a company focused on advancing newborn screening and pediatric testing, today announced that it has signed a bilateral distribution agreement with Trivitron’s Labsystems Diagnostics Oy to deliver a wider range of newborn screening solutions across several global markets. Baebies will distribute Labsystems’ newborn screening products in the U.S. after obtaining regulatory clearance, while Labsystems will distribute Baebies’ SEEKER® platform internationally; SEEKER is FDA authorized and CE marked. SEEKER is a high throughput laboratory solution for newborn screening and is currently configured to perform testing for certain lysosomal storage diseases.

Press Release
September 8, 2017

SEEKER | Days Matter

Baebies SEEKER is an innovative FDA authorized newborn screening platform for lysosomal storage disorders. With SEEKER, time from punch to referral can be as little as one day! Earlier detection and referral can lead to earlier treatment and can dramatically improve the baby's outcome.

Video
September 6, 2017

SEEKER | No Maintenance

Baebies SEEKER is an innovative FDA authorized newborn screening platform for lysosomal storage disorders. SEEKER is a product you can count on from day one, requiring no daily maintenance or upkeep!

Video
August 24, 2017

SEEKER | Ease of Use

Baebies SEEKER is an innovative FDA authorized newborn screening platform for lysosomal storage disorders. SEEKER's ease of use can simplify the newborn screening process in your lab. If you can pipette, you can use SEEKER!

Video
August 10, 2017

SEEKER | Simple Installation

Baebies SEEKER is an innovative FDA authorized newborn screening platform for lysosomal storage disorders. SEEKER installs easily into your newborn screening lab, requiring no renovations or additional equipment. Simply plug it in!

Video
August 1, 2017

SEEKER | Introduction

Introduction video for SEEKER, an innovative FDA authorized newborn screening platform for lysosomal storage disorders. SEEKER is the ideal solution to empower your newborn screening lab and integrates easily into your workflow.

Video
August 1, 2017

Newborn Screening Legislation Expands Test Panels in Several US States

Missouri will be the first state in the US to screen for mucopolysaccharidosis II (MPS II), otherwise known as Hunter syndrome and spinal muscular atrophy (SMA), two life threatening genetic diseases. The state is already screening for several LSDs using the SEEKER platform. Florida recently passed legislation that requires the Advisory Council to consider every condition added to the RUSP within 1 year, and if recommended, the NBS lab would be required to screen for that condition within 18 months.

Announcement
July 31, 2017

Baebies Announces CE Mark for SEEKER, an Innovative Newborn Screening Platform for Lysosomal Storage Diseases

Baebies is pleased to announce that SEEKER, a high throughput newborn screening laboratory solution, now has CE Mark and available in Europe and other countries that recognize CE Mark. SEEKER quantitatively measures the activity of lysosomal enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry disease.

Press Release
July 31, 2017

Baebies Announces Assays for FINDER Launch Panel: G6PD, Total Serum Bilirubin, Albumin and Direct Bilirubin

Baebies, Inc., a company focused on advancing newborn screening and pediatric testing, announced the first assays on the FINDER launch panel, currently under development. The panel includes tests for total serum bilirubin, albumin, direct bilirubin, and glucose-6-phosphate dehydrogenase (G6PD) on a single cartridge, making it the first comprehensive, rapid and near-patient testing solution for hyperbilirubinemia. A robust pipeline of future panels for other disorders using the same cartridge on FINDER is also in development.

Press Release
June 22, 2017

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.

White Paper
June 7, 2017

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.

White Paper
February 27, 2017

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.

Press Release
February 3, 2017

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.

Press Release
August 24, 2016

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.

Announcement
July 30, 2016

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.

Press Release
June 30, 2016

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.

Press Release
May 27, 2016

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.

Announcement
July 28, 2015

Baebies, Inc. Raises $13 Million in Oversubscribed Round of Financing

Baebies, Inc. today announced the completion of a round of equity financing totaling $13 million. The oversubscribed round of financing included key investors Rex Health Ventures, DUMAC, LLC (managers of the Duke endowment), Cunning Capital, Triad, LLC, the Duke Angel Network and a loan from the North Carolina Biotechnology Center. Many of Advanced Liquid Logic’s (ALL) former investors including Charleston Angel Partners, and Baebies’ executive team, also invested.

Press Release