The Importance of Laboratory Developed Tests in Diagnosing COVID-19

WASHINGTON – Laboratory developed tests play a vital role in getting patients accurate diagnoses and effective care, and at no time has their importance been clearer than during the current pandemic. In this briefing, AACC’s leading experts in laboratory medicine will discuss why laboratory developed tests are crucial to fighting the coronavirus, as well as the regulatory barriers that nearly prevented labs from developing and introducing these tests for the virus. 

Speakers will address:

• The development and use of coronavirus laboratory developed tests and how they are regulated

• How laboratory developed tests are used to diagnose COVID-19 patients and why they are important to patient care

Laboratory developed tests are non-commercial tests that labs create and use internally, and the labs that perform these tests meet stringent regulatory requirements under CMS and the Clinical Laboratory Improvement Amendments. When the pandemic first began and almost no commercial coronavirus tests were on the market, it was these CMS-certified labs that developed, validated, and performed laboratory developed tests for the virus, enabling patients to access testing much faster than if the U.S. had waited for commercial tests to become available. 

Over the last several years, FDA has tried to make the case that it should regulate laboratory developed tests in addition to CMS. However, this proposed FDA regulation would be duplicative and burdensome, and would only stymy the ability of labs to respond quickly to new conditions such as COVID-19. Thankfully, the Department of Health and Human Services recently declared that FDA does not have authority to regulate laboratory developed tests without formal notice-and-comment rulemaking. Moving forward, it is vital that any future changes in healthcare policy and regulation follow suit and continue to ensure patient access to these essential tests. 

Speakers:

• Moderator: Patricia Jones, Children’s Medical Center, Dallas, TX
• Dennis Dietzen, St. Louis Children’s Hospital, St. Louis, MO
• Carolee Estelle, Parkland Health and Hospital System and University of Texas Southwestern Medical Center, Dallas, TX

RSVP: Email Christine DeLong, AACC Senior Manager, Communications & PR at [email protected]. 

How to access the briefing: On Wednesday, October 14 at 2 p.m. Eastern Time we will email a link to the briefing to everyone who RSVPed. 

After you receive the link, you will be able to watch the briefing at any time. 

About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.