Minimizing Blood Loss from Testing of Neonatal and Pediatric Patients
Durham, N.C. – (May 19, 2021) – Baebies, a growth-stage company developing innovative products to enable early disease detection and multifunctional diagnostics for syndromic testing, was recently awarded $2.7 million in a Phase IIB SBIR grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). This award supports validation, clinical evaluation, and FDA submission of a rapid test panel for near-patient heparin monitoring. This project is a continuation of a long-standing collaboration with Boston Children’s Hospital to develop a low blood volume platform for heparin monitoring particularly for neonates and pediatric patients.
Heparin is an anticoagulant prescribed to patients at high risk for thrombosis or who are being treated for conditions requiring anti-coagulant therapy such as those with congenital heart defects or other hospitalized patients. A patient who undergoes cardiac surgery will invariably be put on heparin to prevent blood clots. The exact dosage of heparin is critical and should be closely monitored in order to avoid either excessive bleeding or clotting.
“Activated partial thromboplastin time (aPTT) and anti-Factor Xa are the most common tests to monitor and adjust dosage of heparin in pediatric patients requiring anticoagulation, but current practice requires frequent blood draws requiring large volumes that can lead to iatrogenic anemia and potentially further blood transfusions,” said Dr. Sitaram Emani, pediatric cardiac surgeon Director of Cardiovascular Program Coagulation Laboratory, and Surgical Director of Adult Congenital Heart Program at Boston Children’s Hospital. “Our work with Baebies minimizes blood loss due to heparin monitoring especially in our smaller patients who have a fraction of the blood volume of adults. Additionally, obtaining results in a near-patient platform within minutes allows timely adjustments of heparin dosage.”
Dr. Emani recently presented data from the feasibility study at the premier pediatric conference 2021 PAS Annual Meeting being held virtually now through June. Baebies’ multifunctional testing platform, FINDER, has been recently featured in 4 additional presentations at PAS demonstrating results from chemistry, immunoassays, molecular, and hematology assays. Combined with the successfully completed Phase I and II projects, funding through this Phase IIB mechanism will complete the product development cycle for Baebies’ FINDER heparin monitoring platform, from concept to product launch. Baebies has a highly successful track record of leveraging NIH funding in launching multiple commercial products as featured recently by NIH in their SBIR Success Stories.
“This work fills a major gap for the diagnostic testing of newborns,” said Ronald Warren, Ph.D., an NHLBI program officer for the project and a member of the Molecular, Cellular and Systems Blood Science Branch in NHLBI’s Division of Blood Diseases and Resources. “Most FDA diagnostic testing is geared toward adults and involves taking large blood samples. If microfluidics is widely commercialized, it could have a huge impact on the treatment of newborns.”
The underlying digital microfluidics (DMF) technology is a method to programmably manipulate tiny droplets of liquid by electrical control of surface tension on a disposable cartridge. Powered by DMF technology, Baebies’ FINDER has recently won the prestigious 2020 AACC Disruptive Technology Award and has been named a finalist for the Medical Device Excellence Awards (MDEA) 2021. Last month, Baebies announced that CARB-X has awarded the company up to $11.6 million in non-dilutive funding for the development of a rapid diagnostic platform for neonatal sepsis.
Baebies – guided by the vision that “everyone deserves a healthy start” – develops and commercializes products and services that enable early disease detection and comprehensive diagnosis. Baebies has shipped over 10 million tests. Baebies’ SEEKER® is an FDA-authorized and CE-marked high throughput newborn screening platform. Recently launched, Baebies’ FINDER SARS-CoV-2 Test and the FINDER 1.5 Instrument are now available for sale in the U.S. – both of which have been validated but FDA’s independent review of this validation is pending. FINDER®, a CE-marked flexible, single sample testing platform for G6PD deficiency, is under FDA 510(k) review and is currently not commercially available in the U.S. Our mission is to save lives and make lives better for all by bringing new technologies, new tests and new hope to children, parents and healthcare professionals worldwide. To further our mission, Baebies also provides expanded newborn screening services from our CLIA-certified laboratory. Baebies is headquartered in Durham, North Carolina. For more information, visit baebies.com and follow us on LinkedIn, Twitter and YouTube.
- Press Release: Baebies Awarded up to $11.6 Million from CARB-X for the Development of a Diagnostic Platform with Rapid Results for Sepsis
- Press Release: Baebies Wins the 2020 AACC Disruptive Technology Award
- Blog Post: 5 Things to Know about Testing with Digital Microfluidics
- Publication: A Novel Point-of-care Device for Measuring Glucose-6-phosphate Dehydrogenase Enzyme Deficiency
- White Paper: Do More With Less: Approaches to Minimize Blood Loss in Critically Ill Newborns and Children