Annual Report Annual Report 2015 : Page 11

NE W B O RN S C REENING The Newborn Screening and Genetics Program and partners at the Colorado School of Public Health celebrate Newborn Screening Awareness month in September Alisha Wruck uses micropipettor to perform laboratory exercise at the Newborn Screening Molecular Training Workshop held at CDC’s Newborn Screening and Molecular Biology Branch in March 2015 What happens when there is no commercial laboratory test? When newborn screening programs want to add a new disorder to their test panels, often they have to develop it them-selves, because there are no commercial test kits for most extremely rare disorders. The first states to screen for severe combined immunodeficiency (SCID), for example, began in 2010; the first commercial, FDA-approved SCID test wasn’t available until 2015. Similarly, when emerging diseases arise — such as chikungunya and Ebola — CDC and governmen-tal public health laboratories are virtually always the first to bring diagnostic tests online. Again, there are no pre-exist-ing FDA-approved commercial test kits. Even today, there is no FDA-approved molecular assay for measles. This ability to create laboratory-developed tests (LDTs) has been crucial to meet emerging public health needs. Yet, FDA is considering changing the rules to make the process more costly and burdensome, and public health laboratories less nimble. In response, APHL called upon its members to speak at a public FDA forum in January 2015 and submitted written comments to the agency. The association remains hopeful that any new FDA LDT guidance will not obstruct potentially life-saving public health laboratory work. Dr. Horng-Yuang Kan performs a laboratory technique with instruction from Dr. Rachel Lee during the Newborn Screening Molecular Training Workshop held at the at the CDC’s Newborn Screening and Molecular Biology Branch in March 2015 Jelili Ojodu and Careema Yusuf and the participants and instructors for the first training workshop on Genetic Education & Counseling for Sickle Cell Conditions (GENECIS) at the University of Ghana, Legon in June 2015 2015 2015 APHL APHL ANNUAL ANNUAL REPORT REPORT 11 11

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