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  • Diagnostics

    Diagnostics 2

    Despite advances in diagnostic technology, there is an urgent need for tests that are easy to use, identify the microbe causing the infection, determine whether it is drug resistant, and provide results faster than current tests. Faster, more accurate tests would help ensure that patients are receiving the best treatment for a variety of infectious diseases, guide more effective infection control practices, and improve the tracking of outbreaks. Better tests would also help protect our dwindling supply of effective antibiotics by reducing their misuse.

    Infectious disease physicians serve as a critical bridge between the laboratory and other health care providers to ensure the proper use and interpretation of diagnostic testing. IDSA is committed to supporting improved diagnostics including providing recommendations to spur research and development of new tests, and encouraging their use in patient care and public health.

    Better Tests, Better Care:  The Promise of Next Generation Diagnostics (PDF) (For Policymakers) 

    Better Tests, Better Care: Improved Diagnostics for Infectious Diseases (Clinical Infectious Diseases) 

    IDSA's Efforts in Diagnostics


    IDSA Comments to FDA on Emergency Use Authorizations (PDF)

    IDSA submitted comments to the FDA on its recent draft guidance that updates the EUA pathway.  IDSA supported the updates that increase flexibility and clarity for sponsors seeking an EUA for diagnostic devices but also expressed concern on the requirement that EUA sponsors seek support from federal agencies responding to an outbreak, and offer recommendations to address these concerns.

    IDSA Shares Evidence on Diagnostics for Transplant Viruses with FDA (PDF)

    In response to IDSA concerns that its proposed regulation of laboratory developed tests (LDTs) may negative impact viral load testing for transplant patients, the Food and Drug Administration (FDA) has expressed a willingness to hold an expert panel meeting devoted to viral load testing for transplant-associated opportunistic viral infections.  IDSA enthusiastically supports this meeting, and developed a letter with peer-reviewed evidence to inform the FDA’s efforts as well as a list of recommended subject matter experts to serve on the panel.

    IDSA Comments on CARB Diagnostics Challenge (PDF)

    IDSA drafted comments to the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA) on the $20 million “Antimicrobial Point-of-Care Diagnostics Test Challenge.”  IDSA strongly supported the prize and its potential to combat antibiotic resistance, and listed considerations around the types of diagnostics needed to achieve the challenge’s objectives.

    IDSA Comments to FDA on Laboratory Developed Tests (LDTs) (PDF)

    IDSA provided comments to FDA on its recent draft guidance to regulate laboratory developed tests (LDTs).  IDSA agrees that LDT oversight is needed; however, it expressed major concerns that the regulatory framework, in its present state, would negatively impact patient access to infectious disease diagnostic testing and provided recommendations to improve oversight.

    AMA House of Delegates Approved IDSA Resolution on ID Diagnostics (PDF)

    IDSA developed a resolution for the American Medical Association (AMA) House of Delegates (HOD) in support of policies to advance next generation ID diagnostics research, development, and appropriate use.  The proposal was submitted for consideration at the June AMA HOD meeting by IDSA Representative Dr. Michael Butera, and was approved.

    Diagnostics Reimbursement Improvements Enacted (PDF)

    The Protecting Access to Medicare Act, signed into law on April 1, 2014, included key provisions to strengthen reimbursement for diagnostics tests, as championed by IDSA.

    Infographic: Better Tests, Better Care

    Infographic illustrating IDSA diagnostics policy paper Better Tests, Better Care:  Improved Diagnostics for Infectious Diseases.

    IDSA Responds to House Discussion Draft on Diagnostic Regulatory Reform (PDF)

    IDSA responded to a House discussion draft of legislation to reform diagnostic regulatory oversight for both in vitro diagnostics and laboratory developed tests (LDTs).  In its letter, IDSA expresses serious concern that the legislation may potentially limit patient access to test, while supporting specific provisions that improve upon the FDA proposed regulatory framework for LDTs.  IDSA then lists specific recommendations to improve on the discussion draft’s areas of concern.

    IDSA Makes Recommendations on Diagnostics for 21st Century Cures Legislation (PDF)

    IDSA offered policy recommendations to spur development and appropriate use of rapid infectious disease diagnostics for inclusion in the 21st Century Cures Initiative legislation that is being developed by the House of Representatives.

    IDSA Promotes ID Diagnostics in Congressional Funding Process (PDF)

    IDSA offered members of Congress policy recommendations to promote the development and appropriate use of rapid infectious disease diagnostics as the FY 2016 appropriations process begins.

    IDSA Provides Feedback on Proposed Regulatory Frameworks for LDTs (PDF)

    IDSA submitted comments in response to a House committee’s draft of a new regulatory framework for laboratory developed tests (LDTs). The response requested that any steps to alter the regulation of LDTs appropriately balance the need for oversight with the need to maintain and enhance innovation and patient access to state-of-the-art testing.


    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.

    IDSA Statement to Senate HELP Committee on Laboratory Developed Tests (PDF)

    IDSA provided a statement at the Senate Health, Education, Labor and Pensions (HELP) Committee hearing on laboratory developed tests (LDTs) regarding the important role they play in infectious disease clinical care, public health, and on the potential impact proposed new regulations may have on innovation and patient access to testing.

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