FDA Approves Marketing for Breast Milk Nutrient Test

The US Food and Drug Administration (FDA) has granted marketing to a new diagnostic test capable of measuring nutrients in breast milk.

The Miris Human Milk Analyzer, a test which can aid healthcare providers in measuring concentrations of fat, carbohydrate, protein, total solids, and energy in breast milk, will provide more insight into the nutritional management of newborns and young infants—particularly those at risk for growth failure due to prematurity or other conditions.

As breast milk composition can vary in individuals or even not contain sufficient protein and energy levels, providers are often in need to know the breast milk’s nutrient content in order to help guide nutritional care.

The analyzer tests samples with an infrared spectroscopy system, providing measurements of various nutrients. It is intended for use by trained personnel in clinical settings.

Its accuracy was evidenced by an analysis of 112 samples of human milk, which were tested in both the Miris analyzer and in tests obtained by independent methods. Data showed the investigative test was effective at determining levels of protein, fat, and carbohydrate in the milk. That said, investigators noted information can be limited from the test due to varying conditions: certain therapies taken by a nursing mother could negatively interfere with accurate measures of nutrient levels.

The FDA advised that providers carefully evaluate test results in conjunction with clinical assessments—including weight and growth—to better inform their plans for improving newborn or infant nutrition.

In a statement accompanying the marketing approval, Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices at the FDA’s Center for Devices and Radiological Health, praised the new test as an added tool towards optimizing growth and nutrition in at-need infants and newborns.

“For the first time, doctors have access to a test to help analyze the nutrients in breast milk,” Lias said in a statement. “While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected.”