Lactation Lab receives FDA Breakthrough Device designation for breast-milk-testing device that allows mothers to test for key nutritional elements in their milk
By Nicole Wilkins
Lactation Lab, which offers the most scientifically advanced breastmilk testing available, has announced today that the U.S. Food and Drug Administration (FDA), has granted the company Breakthrough Device designation for its latest device Emily’s Care Nourish Test System that tests and provides a nutritional analysis of breastmilk.
This first-of-its-kind breastmilk (point of care) test allows mothers to test for key macronutrients (fat, protein, carbohydrates) and adjust their nutritional intake accordingly. The test was developed for use in the NICU, hospital clinics, milk banks and home use.
“The FDA Breakthrough Device designation for Emily’s Care Test System is a critical step in serving the most vulnerable infant population,” says Dr. Stephanie Canale, CEO of Lactation Lab. “Research in the past five years demonstrates how important key nutrients are for babies in the first five weeks of life. Nutrition is the only modifiable factor for preterm babies, and our Emily’s Care device provides potentially life-saving data, especially for those at risk of life-threatening conditions.”
The FDA Breakthrough Device designation will expedite regulatory review of Emily’s Care to provide patients and health care providers with quicker access. The designation is only awarded to breakthrough technologies that have the potential to provide effective treatment and diagnosis for life-threatening or irreversible debilitating diseases or conditions.
Founded in 2017 by CEO Dr. Stephanie Canale, Lactation Lab’s proprietary tests were developed by a team of practicing physicians, Ph.D. chemists and toxicologists. The startup company is housed at the Magnify Incubator at the California NanoSystems Institute at UCLA, which provides access to one of the most advanced research labs in the world.
Canale, a physician formerly at UCLA whose practice largely consisted of new mothers and babies, started Lactation Lab to provide parents with scientific and evidence-based insights, resources, and guidance. As a mom with an infant diagnosed with “failure to thrive,” also known as growth faltering, Canale wondered why there was no way to know what was in her own breastmilk.
“The time is now to empower moms with the kind of information and peace of mind I needed during my own breastfeeding journey. During the Covid-19 pandemic, amid the anxiety of leaving the home and going to doctor’s visits, we decided to bring Emily’s Care directly to mothers and take the guesswork out of breastfeeding,” said Canale.
Lactation Lab’s breastmilk-test surpasses the creamatocrit breastmilk test first developed in 1978. This rudimentary test is still widely used in hospitals, NICUs and support centers. Lactation Lab aims to replace the existing test with Emily’s Care, which provides more accurate data than infra-red human milk analyzers. The company also just launched Emily’s Care infant supplement, which is the first infant supplement to receive Clean Label Project Certification and will support breastfeeding babies.
“We would like to continue advancements in women’s health to remove the current stigma around postpartum care and breastfeeding,” said Canale. “The data supports objective, evidence-based decision-making not only for hospitals and NICUs, but also for mothers at home. These are revolutionary steps to improve the standard of care surrounding breast milk for mom and baby.”
About Lactation Lab
Founded by CEO Stephanie Canale, a doctor and mother of two, Lactation Lab is a first-of-its-kind breastmilk testing kit. Lactation Lab analyzes your breast milk for basic nutritional content like protein, carbohydrates, fats, calories, as well as vitamins, fatty acids, and environmental toxins. Results are delivered in a user-friendly report that reads like a food label. Lactation Lab explains how results affect children, offers suggestions for enhancing the quality of milk, and also offers personal consultation. Other products include mastitis screening test strips, and the company recently launched the first and only Clean Label certified infant supplement. Learn more at www.lactationlab.com.
About the FDA Breakthrough Device Program
The FDA Breakthrough Device program enables expedited regulatory assessment of novel technologies with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.
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.