Advocacy - Congressional Briefing

Ensuring Our Children have Access to Quality, Accurate Laboratory Testing

Thursday, October 29, 2025

Time: 12:00 pm - 1:00 pm

Where: Senate Russell Building Room 198

Moderator:

Dennis J. Dietzen PhD, Chair of Pathology and Laboratory Medicine, Phoenix Children's Hospital

Speakers:

Danyel Tacker, PhD, Clinical Professor, West Virginia University Hospitals, WVU Clinical Laboratory
Newborn Screening – Early Diagnosis Leads to Better Outcomes

Stanley Lo, PhD, Professor, Pathology, Medical College of Wisconsin; Children’s Wisconsin Clinical Laboratories
Pediatric Reference Intervals – The Need for Better Diagnostic Tools

Dennis J. Dietzen PhD, Phoenix Children's Hospital
Laboratory Developed Tests (LDTs) - Critical to Ensuring Healthy Children

There are 73 million children in the United States, 22 million of them under the age of 5. More than half of the 30 million Americans with a rare disease are children. More than 4 million babies are born annually, each of whom is screened for a series of potentially lethal conditions that are treatable if captured early.

For two decades, federal and state policymakers have worked together to identify and develop treatments for newborns with rare diseases. This collaboration has saved and improved the lives of thousands of babies. Maintaining this federal-state partnership is essential to continuing to meet the ongoing needs of those young children in need of help.

Care for our youngest doesn’t stop with birth. Laboratory tests are vital to diagnosing and treating children from infancy through adolescence to adulthood. While the tests are precise and accurate, healthcare providers need results from pertinent healthy populations to appropriately interpret the results and determine how to treat the child. Unfortunately, these reference intervals (normal ranges) are often of poor quality or nonexistent, resulting in unnecessary testing, misdiagnosis, and unnecessary intervention. Better reference intervals are vital to improving the health of children.

To further complicate matters, few test manufacturers develop tests for young children because childhood disorders are rare. Laboratories have filled this gap by developing their own test methods (LDTs). Without these LDTs, children would remain undiagnosed, causing irreparable pain and suffering to some and death to others. Existing federal regulations assure the accuracy and quality of these tests. In recent years, there have been efforts to create duplicative regulations that could endanger access to these tests.

The Association for Diagnostics & Laboratory Medicine invites you to attend this special briefing on children’s health so you can understand the importance of laboratory testing in pediatric care and how Congress can help ensure that America’s children continue to have access to quality testing.