Lactation Lab receives FDA approval for novel point-of-care device that tests for key nutritional elements in breastmilk

Lactation Lab, pioneers in breastmilk nutrition testing, has been granted full approval by the U.S. Food and Drug Administration (FDA), for its breakthrough device, Emily’s Care Nourish Test System which provides point-of-care nutritional analysis of breastmilk.  

Premature infants have increased nutritional needs, requiring that breastmilk be fortified with additional macronutrients in NICUs.  Standard fortification is a one size fits all approach where assumptions are made about the baseline macronutrient content of breast milk.  Because there can be large variations in the macronutrient content of breast milk in neonatal care, NICUs have sought to provide individualized targeted fortification which has shown improved neurodevelopmental, intestinal, renal, and behavioral outcomes.  However, the technologies used to provide targeted fortification have been costly and impractical to implement.  Emily’s Care Nourish Test System provides simple and inexpensive breastmilk testing to accurately fortify feeds and optimize nutrition for preterm infants in the NICU.

Emily’s Care Nourish Test System, a first-of-its-kind breastmilk analysis device, measures protein, fat and lactose levels in human milk and calculates the caloric content. The device consists of a test strip that requires only a small volume of breastmilk and is read using an iPhone app.  Test results are provided within minutes.  Understanding the nutritional composition then allows for targeted fortification of the breast milk to ensure precise nutritional intake for the most vulnerable babies.  The device was developed for initial use in the NICU, hospitals, clinics and milk banks, but may have future application to help prevent infant malnutrition more widely

“As a family doctor and a mom myself, I realized there were few tools available to test breastmilk and analyze the nutritional content,” said Canale. “For babies, especially those born prematurely and admitted to the NICU, breastmilk is the only modifiable nutrition factor that improves clinical outcomes. By understanding the nutritional contents of a mother’s breastmilk, and allowing for targeted fortification adjustments, we can make a significant difference during that first crucial period of an infant’s life.”

Full FDA approval for Lactation Lab’s point-of-care test comes after receiving FDA Breakthrough Device Designation in 2022 which helped expedite regulatory review of the test to provide patients and healthcare providers with quicker access. FDA approval demonstrates that the product is safe and effective for its intended use.

Lactation Lab was founded in 2017 by Dr. Stephanie Canale to provide lab-based breast milk nutrition analysis and is the only lab that currently provides this service directly to consumers.  Lactation Lab’s proprietary tests were developed at UCLA by a team of practicing physicians, scientists, and chemists.

The World Health Organization, Centers for Disease Control and Prevention and American Academy of Pediatrics recommend infants be breastfed exclusively until six months of age with breastfeeding continuing as an important part of the infant’s diet until at least two years old.

Lactation Lab is housed at the Magnify Incubator at the California NanoSystems Institute at UCLA, which provides access to advanced research labs and instrumentation for startup companies.

“Magnify Incubator is proud to support Lactation Lab in their groundbreaking achievement,” said Nikki Lin, Director of Entrepreneurship and Commercialization at the CNSI as well as director of the Magnify incubator. “The FDA approval of the Emily’s Care Nourish Test System marks a significant advancement in neonatal care, providing precise nutritional analysis of breastmilk. This innovation epitomizes the kind of transformative health solutions we aim to foster at Magnify, enhancing the well-being of both mothers and their infants.”

Ultimately, for Dr. Canale, receiving FDA approval is an incredible achievement. “As a female founder of a startup company we are proud of the company and solution we have created and what this means for improving the standard of care surrounding breastmilk for baby and mom.”

About Lactation Lab

Founded by Stephanie Canale, a doctor of family medicine and mother of two, Lactation Lab developed a first-of-its-kind breastmilk testing kit that analyzes breastmilk for basic nutritional content.  Learn more at www.lactationlab.com.

About the FDA  

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. https://www.fda.gov/

About Magnify Incubator at the California NanoSystems Institute at UCLA

Centrally located at UCLA’s Court of Sciences, Magnify strives to enhance the vibrant culture of entrepreneurship at UCLA and the broader Los Angeles region. Magnify was built with one goal in mind: to help startups succeed by vastly accelerating their access to facilities while increasing their capital efficiency and market opportunities.

Related Links magnify.cnsi.ucla.edu