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  • Senate Health, Education, Labor and Pensions Committee Hearing: “Laboratory Testing in the Era of Precision Medicine”


    The Infectious Diseases Society of America (IDSA) is pleased that the Senate Health, Education, Labor and Pensions (HELP)” Committee has scheduled the hearing, “Laboratory Testing in the Era of Precision Medicine,” for September 20, 2016. Infectious diseases (ID) physicians rely upon diagnostics—both laboratory developed tests (LDTs) and commercial tests—to identify infecting pathogens and their antimicrobial susceptibility and to monitor response to treatment.

    As the FDA considers imposing new regulations on LDTs, it is critical that Congress understand the important role of LDTs in ID patient care and public health, and how the FDA’s draft guidance as currently written could severely limit patient access to testing and quell innovation.

    LDTs are often developed to test for pathogens for which there are no available commercial tests on the market. Additionally, LDTs are often the most rapid testing option available, especially if the only alternative is sending specimens to an external reference laboratory. For individuals afflicted with infectious diseases, delays in testing of even a few hours can have devastating impacts on patients and public health. LDTs have been used to diagnose and manage a variety of infectious diseases since the mid-1990s. They are well designed and validated for reliable use in patient care. In many instances, they have become the diagnostic standard of care. IDSA recognizes that there are valid concerns about potential risks associated with LDTs, particularly in areas such as oncology or genetic testing. However these risks are not equally represented across all areas of medicine, and there is little evidence that ID LDTs provide unreliable results that lead to harmful patient care decisions. IDSA believes that the potential risks raised by the use of ID LDTs are dwarfed by their advances and benefits to patient care.

    In a detailed statement to the Committee, IDSA discussed four examples of how ID LDTs are currently being used: 1) detecting and monitoring opportunistic viruses in patients receiving solid organ and bone marrow transplants; 2) gonorrhea screening; 3) screening for herpes simplex virus infection in newborns (a rare disease with high morbidity and mortality); and 4) diagnosing emerging pathogens during outbreaks, including Zika, Ebola, pandemic influenza and Enterovirus D68.

    IDSA also provided comments on FDA’s draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),” in which we expressed concern that the guidance as drafted could force many clinical laboratories at major academic medical centers to stop or significantly reduce their development and use of LDTs. This could impede patient access to existing high quality or state of the art tests. We remain in a productive dialogue with the FDA, and are pleased that the FDA has scheduled a public meeting with the Microbiology Devices Panel of the Medical Devices Advisory Committee in November to discuss one of our recommendations: appropriate classification of tests for detection of transplant- associated opportunistic viruses.

    IDSA also appreciated that the FDA draft guidance provided several categories of LDTs that would be exempt from additional regulatory oversight, including LDTs for rare diseases and unmet medical needs and LDTs used within a healthcare system. However, we are concerned that each of these definitions as written are inappropriately narrow, and would fail to actually maintain adequate access to these categories of tests.

    IDSA appreciates the federal government’s responsibility to ensure that all diagnostic tests used to evaluate patients are safe and reliable. However, we believe that the government can improve the regulation of LDTs in a manner that does not impede patient access to high quality testing or innovation. As we have discussed in our statement to the Committee, we urge policymakers to modernize the Clinical Laboratories Improvement Amendments (CLIA) oversight of laboratories to include clinical validity of LDTs in addition to CLIA’s current regulation of analytical validity. As academic clinical laboratories are already familiar with CLIA, this approach will likely be far less disruptive to patient access to testing than subjecting all LDTs to FDA regulation.

    Diagnostics innovation and patient access to testing are essential to providing high quality ID patient care and protecting public health. IDSA looks forward to working with the Committee, the FDA, and other stakeholders to promote a regulatory environment for commercial tests and LDTs that facilitates innovation and protects patient safety.

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