Today, the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer, a new diagnostic test to aid healthcare professionals in measuring nutrients in breast milk, including the concentration of fat, carbohydrate, protein, total solids and energy. 

The test provides healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions. "Breast milk provides many health benefits to infants, and for many babies, it can meet their new nutritional needs.


But some infants including those who may be born preterm or have certain health conditions may need additional nutrients to support their optimal growth," said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health. "For the first time, doctors have access to a test to help analyze the nutrients in breast milk.

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."

Some infants who are born prematurely or with health conditions may have special nutritional needs. Breast milk composition can vary in individuals, and, in some instances, breast milk may not contain sufficient protein and energy levels for these infants with increased nutrient needs. In those instances, healthcare professionals may want to test the nutrient content of the milk to help guide nutritional care.

Knowing the macronutrient content of the breast milk may improve the health care team and parents make informed decisions on how to fortify breast milk based on the individual needs of the infant.

The Miris Human Milk Analyzer uses an infrared spectroscopy system to analyze samples of human milk and provide a quantitative measurement of fat, protein, and total carbohydrate content as well as calculations of the total solids and energy content contained in the milk. This is a prescription device intended for use by trained health care personnel at clinical laboratories.

The FDA reviewed data submitted by the sponsor of 112 samples of human milk to analyze the performance of the device. For the study, the sponsor tested the same 112 samples in the machine and compared them to the expected correct values obtained by independent methods; both systems provided similar results for each test.

The data showed that the Miris Human Milk Analyzer test was effective at determining levels of protein, fat, and carbohydrate in the milk. There may be conditions that limit the information available from the Miris Human Milk Analyzer. For example, certain medications that a nursing mother may be taking could interfere with the test's ability to measure nutrient levels in breast milk accurately.