ACLA Statement on Recent HHS Announcement Regarding Regulation of Laboratory Developed Tests

Washington, D.C. Following the recent announcement from the U.S. Department of Health and Human Services (HHS) that the U.S. Food and Drug Administration (FDA) will not require premarket review of laboratory developed tests (LDTs) without first going through notice and comment rulemaking, ACLA President Julie Khani released the following statement:

“We agree that labs providing vital testing services during the pandemic need clarity and certainty about how those services are regulated. We appreciate that HHS recognizes the importance of flexibility to innovate for laboratories bringing quality testing services to the market.  We also believe it is critical that all laboratories developing and performing testing for COVID-19—irrespective of the regulatory authorities under which they operate—have the appropriate expertise, equipment and training to develop valid tests and deliver the accurate and reliable results that patients and clinicians depend on.

As a key source of diagnostic quality and innovation, laboratory developed tests play a critical role in our healthcare system, especially during a pandemic. These tests are often developed to address unmet clinical needs and are critical tools in the fight against cancer, rare diseases, and emerging outbreaks. Indeed, in the case of COVID-19, many of the first widely available tests in the U.S. were LDTs developed by ACLA members.

Since the start of this pandemic, ACLA member laboratories have made significant investments in automation and quality checks to maintain the accuracy and reliability of test results while dedicating resources to meet the extraordinary and often unpredictable demand for testing.

To date, ACLA member laboratories collectively have performed nearly 35 million molecular tests for COVID-19 and are actively developing new tests and methods, adapting workflows, bringing on new platforms and retraining workers.  We remain laser focused on continuing to innovate, scale up capacity, and perform tests with quick turnaround time for the patients and clinicians who are counting on us.”


The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.

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