On September 9th I testified before the U.S. House of Representatives Energy and Commerce Health Subcommittee at a hearing entitled 21st Century Cures: Examining the Regulation of Laboratory-Developed Tests. This forum followed the announcement by the Food and Drug Administration (FDA) of its intention to issue draft guidance in 60 days to newly regulate LDTs. This is a pivotal moment for the clinical lab industry, and moving forward it is essential we consider all the ramifications of this proposal.

The American Clinical Laboratory Administration (ACLA) and its member laboratories are committed to developing and providing safe, reliable, and clinically meaningful diagnostic testing services to patients as well as ensuring adequate and appropriate regulatory oversight of the tests they perform. However, ACLA and the FDA fundamentally disagree on several key issues, including its perceived statutory authority to regulate LDTs and the promulgation of new regulatory oversight through guidance documents.  

As detailed in the Citizen Petition filed by ACLA last year, ACLA strongly believes that the FDA cannot regulate LDTs, through guidance or otherwise, for several reasons. Most important, LDTs are not “devices” as defined by the Food, Drug and Cosmetic Act (FDCA). As the text and legislative history of the “device” definition show, this term encompasses only articles. LDTs are proprietary procedures for performing a diagnostic test using reagents and laboratory equipment. They are essentially know-how, not physical articles. 

In addition, commercial distribution is an essential prerequisite for FDA jurisdiction under the FDCA. The FDA has defined “commercial distribution” in various contexts to require that a product be delivered, distributed, or placed on the market. LDTs are created and performed in a single laboratory, not manufactured and distributed.

Finally, in 1988 when Congress amended the Clinical Laboratory Improvement Amendments (CLIA), the current regulatory framework for LDTs, it explained its intent to regulate laboratory testing under a single statute: the amended CLIA. To that end, Congress created a comprehensive statutory framework for precisely the services that FDA now seeks to regulate under the device authorities of the FDCA.

There is limited rationale for duplicating existing regulation that has proven effective for the lab industry, as well as patients benefitting from LDTs, in that it provides appropriate safety protocols and does not stand in the way of innovative diagnostic discoveries. Improvements can be made to the regulation of LDTs, but they should be addressed within the existing CLIA regulatory structure for continuity and efficiency. 

However, challenges can present opportunities, and the FDA’s current proposal provides a forum for the lab industry to educate members of Congress and other stakeholders about the history of LDTs, their value to society, and the regulatory framework that has allowed ongoing advances in diagnostics.  

LDTs are an extremely common part of laboratory medicine and the backbone of clinical care in the United States. The diagnostic information they yield empowers patients and their doctors with the tools they need to best manage patient care. Nearly all FDA-approved and FDA-cleared test kits begin as LDTs, and, in many cases, LDTs represent the standard of care. 

A large proportion of the clinical laboratory tests performed in this country are performed as LDTs, from routine tests such as pap smears and complete blood counts, to the most cutting-edge molecular and genetic tests in cancer, heart disease, and rare and infectious diseases. These are tests developed by physicians, scientists and other highly-trained personnel working in a single laboratory, according to its own processes, to furnish a diagnostic result for use by a clinician. These tests most often are created in response to an unmet clinical need, or where the existing diagnostic tests are insufficient or fail to incorporate the latest in scientific and medical research.

LDTs have played a central role in diagnosing epidemics as well as providing crucial information to oncologists. They have helped eliminate trial and error treatments and get the right therapy to the cancer patient, thereby saving precious time. For instance, no HIV-1 antibodies confirmatory test was available when the HIV-1 screening test was introduced in 1985. Clinical laboratories developed and validated the Western blot test to meet the critical need to establish definitive diagnoses of HIV-1. It took two years before an FDA-approved Western blot test became available. Another example of the dynamic role of LDTs in transforming clinical care is a genomic LDT shown to predict whether chemotherapy is likely to benefit women with early-stage invasive breast cancer. The test has helped many patients avoid costly, chemo-toxic, and ultimately unnecessary treatments and led to better outcomes.

Providing the regulatory framework for these groundbreaking advances is CLIA. CLIA creates stringent requirements governing the operation of clinical laboratories to ensure the safe and accurate function of laboratories and the testing services they provide. These requirements cover the laboratories themselves, the necessary certifications for laboratory personnel from pathologists and geneticists to technicians, and the documentation of procedures for individual clinical laboratory tests. In addition, laboratories are also subject to inspections under both CLIA and state law. Further, many moderate and highly complex laboratories, including all ACLA members, submit to additional oversight through deemed peer review authorities, such as the College of American Pathologists and the Joint Commission, and others, which adds additional expertise in reviewing both the operation of the laboratory and the analytical and clinical validity of individual tests. This additional oversight for moderate and high complexity laboratories also involves the use of proficiency testing to ensure the accuracy of testing results.  

Technology can move at lightning speed though, and regulation must fit the current pace of innovation. ACLA has long supported modernizing the regulatory requirements under the CLIA program to stay current and effective within the diagnostic world of LDTs. We are confident there are policies that can be developed to accomplish this without doubling or tripling the regulation, oversight, and cost.

Medical innovation in the U.S. has moved healthcare ahead by leaps and bounds, and even more exciting innovations are just on the horizon. Clinical laboratory diagnostics are a critical and powerful tool in this effort and will enable us to provide patients with higher quality healthcare at lower costs. To the extent that additional oversight of LDTs is necessary, ACLA asserts it can be implemented through amendments to CLIA and should strike the right balance between innovation, safety, and patient access.