Posted 12/17/2018 by Richard West and Vamsee Pamula,
Founders of Baebies

Four years ago, we started Baebies with a singular mission to save lives and make lives better for all children. Today, we celebrate the shipment of our 4 millionth test to newborn screening programs. Six states are now using Baebies SEEKER, the first FDA-cleared newborn screening platform for lysosomal storage disorders (LSDs). Our digital microfluidics technology has helped to identify babies with these rare diseases early enough to start treatment before life-threatening symptoms appear. By working closely with state newborn screening programs, we have helped children thrive, such as Georgia – a bubbly four-year-old with Pompe disease.

We are proud of our work so far in contributing to millions of healthy starts for babies across the U.S. The extra ‘e’ in our name is a daily reminder to us that every child, here and worldwide, deserves a healthy start. So, what’s next?

Take SEEKER International

Baebies has officially gone global! We have secured our first customer outside the U.S. and will be sending SEEKER overseas this month. SEEKER is the only practical newborn screening solution for many countries around the world because of its flexibility, easy installation, zero maintenance requirements, and simple workflow. Whether a lab is testing 40 babies a day on one instrument or over 400 babies a day with three runs on a four-instrument workstation, SEEKER fits on a standard lab bench. We are agile and poised to get more pilots up and running for LSD screening worldwide.

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Expand State Newborn Screening Panels

Currently, 17 out of 53 U.S. states and territories are screening for Pompe disease and even fewer for MPS I, Fabry, and Gaucher. Many precious babies are becoming disabled while the implementation is delayed. Days matter for Pompe and years are rolling by! In 2019, we want to see more states adopt the Secretary of Health’s recommendation to screen all their newborns for Pompe and MPS I. As advocates for babies with rare and congenital diseases, we will work with newborn screening stakeholders across the country to help accelerate implementation.

Although the Secretary’s committee has thoroughly vetted the additions of Pompe and MPS I to the Recommended Uniform Screening Panel, each state still has to adopt the recommendation. During that process, some states and their advisory committees prefer to see more evidence on effectiveness of screening. State newborn screening staff do a terrific job of ensuring every baby, within their mandate, gets a healthy start and we work closely with our customers to help analyze data in support of expanding screening for LSDs to other states. Our work goes above and beyond the typical lab-vendor relationship. Baebies is a partner with our state public health lab customers and we will continue to invest in the progress of newborn screening programs.

Address the Gap with Supplemental Newborn Screening

While newborn screening is one of the most successful U.S. public health programs, each state on average screens for just over 40 conditions. Therapies are available for hundreds more conditions. With many of these conditions, the symptoms are not obvious at birth. Without newborn screening, families are set off on diagnostic odysseys spanning years, missing the precious window within which clinical outcomes could be better with early intervention. We believe that this diagnostic odyssey is unnecessary, expensive, and emotionally draining for patients and families.

To bridge the gap between state public newborn screening programs and available therapies, Baebies developed Eli, an innovative supplemental newborn screening service for families because Every Life is Important. Eli serves to supplement, and not compete with, the screening that is typically conducted in public health labs around the world.

 

As of October 2018, Eli is now available for expecting families to purchase in most of the United States. Eli screens for 32 treatable conditions; samples are tested in our CLIA-certified lab on site at our headquarters in Durham, NC. We will continue to develop new newborn screening tests, add them to the Eli panel, and create additional channels to bring these new tests to newborns.

Introduce FINDER

When it comes to healthy starts, high throughput, lab-based newborn screening is just one part of the solution. For newborns who stay in neonatal intensive care units (NICU), there are no panels of tests devised addressing their unique needs. That’s why we are developing FINDER, a small, innovative and connected testing solution that is designed to use a tiny blood sample to quickly perform time-critical tests. Utilizing a single instrument and many disease-specific cartridges, FINDER is designed solely to address the needs of babies in the NICU and pediatric patients. Our launch panel on FINDER is for jaundice, including tests for Glucose-6-Phosphate Dehydrogenase (G6PD), Total Serum Bilirubin, and Albumin. In August, we began pre-clinical evaluation at Stanford University. 2019 will be a milestone year for FINDER as we get ready for commercialization.

With the holidays upon us, we pause to spend time with our families and we are reminded of life’s most cherished gifts – health and happiness. We celebrate the healthy starts that have been aided by our four million tests and look forward to still many more in the coming year. Besides many others in the newborn screening ecosystem, much of the credit goes to our fellow Baebies employees who are driven to accomplish our mission of ensuring a healthy start to all babies. Baebies will be there, bigger and better in 2019. We hope you will stay tuned to our progress in the new year.

Happy Holidays to you and your family!

Richard West and Vamsee Pamula
Founders of Baebies