Baebies Delivers a Landmark 10 Million Newborn Screening Tests
Baebies, a Durham-based company specializing in disorder screening for newborns, has reached a company milestone of 10 million tests delivered to labs since its founding in 2014 that was bootstrapped by the North Carolina Biotechnology Center.
The company seeks to promote a healthy start in newborns’ lives using digital microfluids technology, which quickly and efficiently reads a small fluid sample for a variety of disorders. In the United States, more than one in 300 babies have a condition that will appear in these lab tests. Early detection of congenital disorders can provide a baby with proper therapy, often saving their lives.
NCBiotech awarded the company a $500,000 loan in 2014.
Baebies licensed its microfluidics technology from Illumina, a global genetic sequencing and genotyping company based in San Diego. Illumina, which has an equity stake in Baebies, acquired the technology from Morrisville-based Advanced Liquid Logic in 2013 for $96 million. Advanced Liquid Logic was a Duke University spinout company co-founded by President Vamsee Pamula, and led by CEO Richard West. So the technology has made an ironic full circle with Baebies.
Since receiving the financial boost from NCBiotech in 2014, the company has worked on building its product portfolio with two newborn testing systems, SEEKER and FINDER. Approved by the U.S. Food and Drug Administration in 2017, Baebies’ product SEEKER identifies rare lysosomal storage disorders, which cause toxic buildup in the body, damaging cells and organs. Four disorders that SEEKER tests for are Mucopolysaccharidosis type 1, Pompe, Fabry and Gaucher diseases, using only a small spot of dried blood. It can also aid in detecting Galactosemia and biotinidase deficiency by identifying reduced enzyme activity. Presently, one in seven babies born in the United States is screened using the SEEKER technology.
FINDER won the 2020 American Association for Clinical Chemistry’s Disruptive Technology Award and is currently under FDA 510(k) review. The system tests for glucose-6-phosphate dehydrogenase (G6PD) deficiency, which causes the premature breakdown of red blood cells. In the United States, one in 10 African American males present with this genetic condition, but many are unaware because they have never experienced symptoms. The FINDER test takes only 15 minutes, providing a necessary resource for G6PD detection
Both the SEEKER and FINDER technologies offer hospitals and labs a superior testing system, because they are small, cost efficient and require a smaller blood sample than other newborn screening tests. Also, multiple tests can be performed simultaneously, allowing for a quicker response.
Much of Baebies’ success has occurred in the last year, when it delivered three million of the 10 million tests.
“The milestone translates to 10 million chances to save a life,” co-founder and Chief Executive Officer Richard West said in a news release. With the first 10 million screening tests under its belt, West said Baebies looks forward to continuing developing and supplying its technology to hospitals and labs around the country, expanding its existing footprint in the newborn-disorder screening field.