The Food and Drug Administration (FDA) has permitted marketing of the Miris Human Milk Analyzer to help healthcare professionals measure nutrients in breast milk, including fat, carbohydrate, and protein concentrations, total solids and energy. 

The test is intended to aid clinicians in the nutritional management of newborns and young infants who are at risk for growth failure due to prematurity or other medical conditions. Healthcare professionals and parents can make informed decisions on how to fortify the breast milk based on the individual needs of the infant once the macronutrient levels are determined.

The Miris Human Milk Analyzer uses an infrared spectroscopy system to analyze milk samples and provide measurements of fat, protein, and total carbohydrates (including total solids and energy) found in the milk. To test the accuracy of the device, 112 human milk samples were analyzed and the values were compared to those obtained through other measuring methods. Results showed that the Miris test was effective at determining levels of protein, fat, and carbohydrate in the breast milk.

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Test results should be evaluated in conjunction with clinical assessments (weight and growth) when creating a nutritional management plan for an infant or newborn. In some cases, results may be limited, such as when a nursing mother is on a medication that may interfere with the test’s ability to accurately determine nutrient levels.

“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,” stated Courtney Lias, PhD director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health.

The diagnostic test is a prescription device for use by trained healthcare personnel at clinical laboratories. 

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