Posted 12/18/2019 by Richard West and Vamsee Pamula,
Founders of Baebies
Every company starts with a vision. It provides focused direction. We founded Baebies with the vision that “everyone deserves a healthy start”. Throughout the past 5 years and to this day, our work truly reflects this vision.
Looking back on 2019, we further diversified our offerings in order to reach more babies and impact the lives of all children faster. Here’s a look back and a glimpse at what’s to come:
6 Million Newborn Screening Tests Shipped Globally
To date, Baebies has shipped a total of 6 million newborn screening (NBS) tests – which translates to 6 million chances to save a life. This year alone, we shipped over 2 million tests including our first international shipments. Our FDA-authorized, CE-marked newborn screening platform SEEKER® is used to screen babies in the U.S. (installed in 7 states) and Qatar. Multiple international locations have conducted initial pilot studies with plans to start live screening with SEEKER in early 2020. SEEKER’s flexible throughput, small footprint, easy installation and simple operation makes it an ideal solution for many NBS programs.
Our team traveled the globe to over a dozen conferences discussing the expansion of newborn screening with expert clinicians and NBS thought leaders. While we discussed plans for adoption of NBS for lysosomal storage disorders (including MPS I, Pompe, Gaucher and Fabry diseases), we also shared plans for expansion of Baebies assay pipeline including tests for biotinidase deficiency and galactosemia.
First Anniversary of Testing in Baebies CLIA-certified Laboratory
To further expand our newborn screening efforts, Baebies launched our CLIA-certified laboratory in late 2018. One of the services offered by this lab is second tier testing by DNA sequencing for public health labs. Multiple state NBS programs are performing first tier newborn screening with SEEKER and sending any positive screens to our lab for second tier sequencing to further reduce the false positive rate and referral burden to follow-up programs.
FINDER™ Receives CE Mark, Clinical Trials Underway
Life-threatening conditions for newborns require multiple tests and large sample volumes for an accurate diagnosis. Minimizing blood loss in critically ill newborns and children can save lives. Baebies’ solution is FINDER. FINDER uses one drop of blood to test for Glucose-6-Phosphate Dehydrogenase (G6PD) and is designed specifically around neonatal and pediatric patient needs.
This month FINDER received CE mark, with plans to apply for FDA clearance in early 2020. Clinical trials are underway at multiple sites. The first international clinical evaluation will start in the new year.
Our plans for 2020 include expanding our customers and obtaining CE marking and FDA clearance for additional NBS assays on SEEKER and diagnostics panels on FINDER.
But we cannot look ahead without first recognizing the contributions of our employees and supporters.
None of this would be possible without the Baebies staff. Our 90-person team can be described by our core values: innovative, customer-centric, high-velocity and mission-driven.
To our investors, we appreciate your backing as we grew our Series B to $19M.
We are thankful that the National Institutes of Health (NIH) continues to be a supporter of our work through grants including recently awarded Phase IIB SBIR Grant for Hyperbilirubinemia Testing Solution.
To our board, collaborators, informal advisors, and advisory board members – thanks for your guidance, time and participation at events with our team.
It is important to remind ourselves, especially around the holidays, why our work matters. During Newborn Screening Awareness Month, we shared the story of two-year-old Maggie who was diagnosed with MPS I, a progressively debilitating genetic disorder, just after her first birthday. Her diagnostic odyssey could have been avoided with newborn screening. There is still much more work to do to reach all children – in the U.S. and beyond – with products and services that enable early disease detection and comprehensive diagnosis. We look forward to reaching millions more families in 2020.
Happy Holidays to you and your family!
Richard West and Vamsee Pamula
Founders of Baebies