ACLA Statement on Changes to LDT Regulation and Review
Following the announcement from U.S. Department of Health and Human Services Secretary Xavier Becerra regarding regulation and review of laboratory developed tests (LDTs), ACLA President Julie Khani issued the following statement:
“Laboratory developed tests (LDTs) are a vital tool in our fight against complex and often devastating diseases facing patients and their families. Clinical experts rely on LDTs to fill emerging gaps in medical care for which a test may not currently exist, such as for cancers and rare diseases. In the case of COVID-19, many of the first tests available were LDTs developed by ACLA member companies. As this pandemic has illustrated, a clear and nimble regulatory framework with appropriate and clear pathways for test development is essential to public health and patient care.
Today’s announcement from the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) marks another shift in federal policy regarding the regulation of LDTs. While we appreciate the Administration’s focus on the need for high-quality testing, continually shifting regulatory policies creates uncertainty and undermines patient access to lifesaving diagnostics. This underscores the clear need for comprehensive diagnostic reform legislation that can provide long-term clarity and continuity for clinical labs and their work to support medical breakthroughs moving forward. We remain focused on the continuing pandemic response and our continued work with stakeholders and congressional leaders to advance meaningful comprehensive diagnostic reform and achieve this shared goal.”
To view ACLA’s previous letter to Secretary Becerra on LDT regulation, click here.
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.