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Laboratory developed tests (LDTs) are non-commercial tests that labs create and use internally. These tests play a vital role in getting patients accurate diagnoses and effective care, and at no time has their importance been more evident than during the current pandemic. When the coronavirus first reached the U.S., the only widely available test for the virus was flawed. As a result, healthcare providers had to rely instead on LDTs created by commercial laboratories and academic medical centers to diagnose and triage patients.
As the pandemic goes on, LDTs continue to play a critical role in efforts to combat the coronavirus. In this video, AACC laboratory experts discuss this in detail, as well as the regulatory barriers that nearly prevented laboratories from developing and introducing these tests for the coronavirus.
Patricia M. Jones, PhD, DABCC, FACB, is a professor of pathology at University of Texas (UT) Southwestern Medical Center and medical director of laboratories at Children’s Medical Center in Dallas. Dr. Jones is a past president of AACC and is currently the chair of AACC’s Policy and External Affairs Core Committee, which is responsible for providing guidance to the AACC president and board of directors on legislative and regulatory issues.
Dennis J. Dietzen, PhD, DABCC, FAACC, is a professor of pathology and immunology and of pediatrics at Washington University School of Medicine and medical director of laboratory services at the St. Louis Children’s Hospital in Missouri. Dr. Dietzen is a past president of AACC and is a member of the Society for Pediatric Research, the Society for Inborn Metabolic Disorders, and the Academy of Clinical Laboratory Physicians and Scientists. Dr. Dietzen also received the AACC Award for Outstanding Contributions to Pediatric Clinical Chemistry in 2012.
Carolee D. Estelle, MD, is an assistant professor in the department of internal medicine at UT Southwestern Medical Center. She serves as interim chief of healthcare epidemiology for Parkland Health & Hospital System and specializes in infectious diseases. Certified by the American Board of Internal Medicine, Dr. Estelle joined the UT Southwestern faculty in 2017. Throughout the coronavirus pandemic Dr. Estelle has helped lead the response at Parkland Health & Hospital System.
If you have questions about LDTs, please send them to Vince Stine, PhD, AACC’s Senior Director of Government & Global Affairs at [email protected].
You can also learn more about AACC’s policy views on LDTs.