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# Newborn Test for Duchenne’s Cleared for Use
- URL: https://www.fdaweb.com/newborn-test-for-duchennes-cleared-for-use/
- Published: 2019-12-12T12:00:00.000Z
- Updated: 2026-09-14T15:56:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145714

FDA has authorized the *de novo* marketing of PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Newborn screening uses a small amount of blood from an infant’s heel to test for a variety of diseases and conditions. The *de novo* authorization enables laboratories to add the GSP Neonatal test to their newborn screening panel if they choose to do so, the agency says in a release, adding that there is currently no recommendation to do that routinely.

The GSP test works by measuring the concentration of a type of protein called CK-MM, which is part of a group of proteins called creatine kinase, [FDA says](https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-test-aid-newborn-screening-duchenne-muscular-dystrophy?ref=fdaweb.com). “Creatine kinase is found in muscle tissue and CK-MM enters the blood stream in increased amounts when there is muscle damage,” it explains. “This test measures the levels of CK-MM from the dried blood samples collected from the prick of a newborn's heel 24 to 48 hours after birth. Elevated levels of CK-MM detected by the kit may indicate presence of DMD. Results showing elevated CK-MM must be confirmed using other testing methods, such as muscle biopsies, genetic and other laboratory tests.”