Posted 12/22/2020 by Richard West and Vamsee Pamula, Founders of Baebies
We express our deepest gratitude to the laboratory professionals in public health and medical labs during a tumultuous year with the raging pandemic.
Newborn screening did not miss a beat and, of course, hundreds of millions of COVID-19 tests were performed in the past few months. These unsung lab professionals have been quietly working behind the scenes, all the while making a tremendous positive impact. We recently posted this poll to the newborn screening (NBS) community:
In one word, how would you describe your newborn screening program in 2020?
Tenacious. Resilient. Dynamic. Family. These are just some of the words submitted by NBS programs around the world.
And they are words we use to describe our team at Baebies as well. We are grateful to have multiple reasons to celebrate as we reflect on the year:
Winner of the 2020 AACC Disruptive Technology Award
Baebies won the AACC Disruptive Technology Award which “recognizes innovative testing solutions that improve patient care through diagnostic performance or access to high quality testing”. We were selected by a panel of expert judges at the 2020 American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Lab Expo following a presentation on innovative applications of our digital microfluidics technology. Baebies was also selected as the Audience Choice Award winner, determined by audience voting.
Digital microfluidics technology powers both our FDA-authorized newborn screening platform SEEKER and CE-marked near-patient diagnostic platform FINDER - enabling us to meet unmet testing needs with speed and versatility.
Submission of 510(k) to U.S. FDA for Glucose-6-Phosphate Dehydrogenase on FINDER
Nearly 10% of all babies born are admitted to the neonatal intensive care unit, where they are evaluated using tests intended for adults that require large sample volumes. One of these tests is for Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. Newborns with undetected G6PD deficiency are at risk for extreme hyperbilirubinemia. (For more, see this PAS summer series webinar: Evaluation of a near-patient diagnostic platform for G6PD)
Currently under review by the U.S. Food and Drug Administration, FINDER tests for G6PD from low blood volume (50 µL) with a turn-around time of approximately 15 minutes after sample introduction.
Digital microfluidics enables testing with “micro” volumes of sample and reagent with the capability to support multifunctional test methods – including molecular, immunoassay, and chemistry.
In addition to testing for G6PD, we have a robust development pipeline including a SARS-CoV-2 RT-PCR test to detect COVID-19 on FINDER 1.5 currently under development. [1 - updated 4/5/2021]
Our research work (in collaboration with Duke, Stanford, and University of Alabama) on various assays on FINDER was featured in over half a dozen presentations at conferences around the world including acute kidney injury (AKI) and congenital cytomegalovirus (CMV). We started the year with a peer-reviewed article on performing PCR within 5 minutes for CMV and ended with one from our Stanford collaborators.
9 Million Newborn Screening Tests Shipped and New Assays on SEEKER
Every test shipped is a chance to save a life. FDA-authorized newborn screening platform SEEKER is used by laboratory professionals to test 1 in every 7 babies born in the U.S. for lysosomal storage disorders (LSDs). Screening babies for these diseases at birth enables early diagnosis and can lead to earlier initiation of treatment – dramatically impacting the outcome for the baby. We've been working with NBS programs for over 7 years on LSD screening, including providing second tier DNA sequencing services in our CLIA laboratory. (See NBS for LSDs webinar for more.)
This year we contributed to multiple peer-reviewed publications sharing the impact of digital microfluidics technology on NBS:
- Lessons Learned from Pompe Disease Newborn Screening and Follow-up
- Digital Microfluidics in Newborn Screening for Mucopolysaccharidoses
- Emerging Approaches for Fluorescence-Based Newborn Screening of Mucopolysaccharidoses
In May, we announced CE marking (under the IVD Directive 98/79/EC) for newborn screening assays for galactosemia and biotinidase deficiency on SEEKER. We look forward to bringing more healthy starts to babies around the world with these tests.
Our team recently celebrated - at a social distance - over 9 million newborn screening tests shipped since we started Baebies. We are proud to be part of the NBS community. (Read Hari's NBS story.)
Poised for Growth in 2021
As we approach the end of 2020, the world is filled with heroism like never before. Heroism is defined in part by special achievement, especially in the face of difficult circumstances. It is performing great service to your fellow humans despite the risks.
To the Baebies team of over 90 employees, thank you for your heroism. You have embodied each one of our core values – mission-focused, high-velocity, customer-centric, and innovative. While physically apart in 2020, we came together to accomplish major milestones - paving the way for an exciting new year.
2021 will be transformational for Baebies. We’ll be building our commercial organization in the U.S. to launch FINDER in the hospital segment while we continue to grow our newborn screening business. We’ll also be expanding our operations organization – including building a new facility - to prepare for rapid growth. Our product development, technology development, and regulatory teams will be very busy as well bringing new tests to market.
We invite you to follow along on LinkedIn and sign up to stay tuned with our newsletter.
Happy Holidays! All the best in the new year,
Richard West and Vamsee Pamula
Founders of Baebies
 Updated 4/5/2021: FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test have been validated but FDA’s independent review of this validation is pending.